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The Blood Cold Chain - World Health Organization

1. 500 4R E CODE VR 01 ES Li 08 MES al Tee EN OCS E COMPANY NAME AND ADDRESS Advance Galatrek Advance Park Wrexham LL14 3YR United Kingdom Tel 44 1978 82 10 00 Fax 44 1978 81 08 52 E mail sales aelgroup co uk SPECIFICATIONS Nominal voltage 220 V Continuous power 2500 VA Frequency 50 Hz Phase I Input voltage range 145 278 V Output voltage range 198 225 V Input connection 2 metre fly lead Output connection socket with plug specify type required Indicators on input green neon Indicators on output red neon External materials grey painted steel Weight unpacked 10 kg External dimensions unpacked in cm 15 3 x 16 7 x 35 5 No per package 1 Test Report CATR A 92071 1988 Meets WHO UNICEF Standard E7 VR 1 E COMMENTS Unit is fitted with a circuit breaker as well as a 6 12 min delay cut out on input to protect against high low voltage Minimum order 1 Shipping net volume 0 091 m 44 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Equipment maintenance CHAPTER 10 Equipment maintenance is part of the global Health Care Technology Management process The aim of The availability of spare parts does not guarantee the uninterrupted and proper performance of the blood cold chain equipment an equipment maintenance programme is to assure the maximum working life of the equipm
2. in E d a RECEIVER He LIIS MU COMPANY NAME AND ADDRESS MARKETING Berlinger amp Co AG 9608 Ganterschwil Switzerland Tel 41 71 982 88 11 Fax 41 71 982 88 39 E mail info berlinger ch Internet www berlinger ch E SPECIFICATIONS Temperature thresholds 10 C and 17 C External dimensions 12 x 15 cm No per pack 250 pk Minimum order 500 pk 2 packs Test report Lab tested at Which Laboratories UK WHO field tested in 6 countries 1999 E COMMENTS BTTI must be kept at 4 C or below for four hours before activation Shipping net weight 1 7 kg pack 40 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES CHAPTER 9 In addition to the blood cold chain equipment there is a need for devices and accessories to support the equipment broadly grouped under the following headings 9 1 Voltage regulators When a power supply is not stable there are often voltage fluctuations that may damage the compressor fan motors or other electronic components of the cold chain equipment Even if the compressor has been tested for certain voltage fluctuations see performance specifications there may still be a need to protect the equipment by installing a voltage regulator on the power When a power supply lines that supply the cold chain is not stable voltage fluctuations may damage the electronic components of the cold chain eq
3. Item Quantity Tiny TTM G IP68 1x5 Software 1 1 IP 68 Interface cable 1 38 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES E MODEL AUTOLOG 2000 TM E CODE TD 05 PIS E6 47 E COMPANY NAME AND ADDRESS Remonsys Ltd Distributor for Gemini Data Loggers UK Ltd The Stables Church Hanborough Witney Oxfordshire 0X29 8AB United Kingdom Telephone 44 1993 886996 Fax 44 1993 886997 E mail lewis autolog u net com E SPECIFICATIONS Temperature range 30 C to 70 C Accuracy 0 1 C Measuring interval 1 60 mins Memory size 8K Size dxl 195 x 100 x 43 mm External materials ABS plastic case Weight 300 g without sensors 1000g with 4 sensors No per package 1 Power source internal Lithium battery Battery life available 10 years Test Report USDA approved No WHO UNICEF Standard exists E USE Functions as reusable cold chain monitor for use in vaccine refrigerators shipments and cold chain studies It displays and stores data that can be downloaded by special cable to the serial port of a PC with MS Windows supported software Comes equipped with 4 sensors 2 x 6m and 2 x 20m Shipping weight volume 1pk 1 3kg 0 006 m Item Quantity Autolog 2000 1 Software and cable 1 CHAPTER 8 TEMPERATURE MONITORING DEVICES E MODEL THERMO TRACER E CODE TD 06 PIS E6 48 E COMPANY NAME AND ADDRESS OCEASOFT
4. Blood Cold Chain Guide to the selection and procurement of equipment and accessories Department of Blood Safety and Clinical Technology World Health Organization Geneva The Blood Cold Chain Guide to the selection and procurement of equipment and accessories Department of Blood Safety and Clinical Technology World Health Organization Geneva WHO Library Cataloguing in Publication Data World Health Organization The blood cold chain guide to the selection and procurement of equipment and accessories 1 Blood preservation instrumentation 2 Plasma 3 Blood platelets 4 Refrigeration methods 5 Equipment and supplies standards 6 Guidelines I Title ISBN 924 154579 8 NLM classification WH 460 Acknowledgements The Department of Blood Safety and Clinical Technology acknowledges the continued support of the Government of Luxembourg towards the WHO Blood Cold Chain Project and to the production of these guidelines The support of the WHO Department of Vaccines and Biologicals and the WHO Procurement Services are also gratefully acknowledged This publication was prepared under the direction of Mr David Mvere WHO Consultant and edited by Ms Kay Bond BCT WHO Printed November 2002 Copies may be requested from Department of Blood Safety and Clinical Technology World Health Organization 1211 Geneva 27 Switzerland Fax 41 22 791 4836 E mail bct who int www who int bct Information on procuring
5. set of fan belts 1 water pump 1 fuel pump with plunger and delivery valve 1 set of front and rear oil seals 1 gasket O H set 1 set of piston rings 1 sets of decarbonizing joints 2 set of nozzles 1 set of inlet and exhaust valves with guides 1 set of brushes 1 set of rubber parts 2 if used at places liable to distortion set of hose pipes 1 air oil fuel filters 5 Other recommended items Mains isolator switch fuse protection for all phases for the generator a see through fuel gauge this is a cheap feature which enables the operator to see at a glance whether the unit needs refilling Soundproofing Soundproofed enclosures are usually expensive and could be the subject of a separate bid Locally made brick enclosures are often a cheap 42 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES soundproofing option and in the case of units installed outside provide protection against the weather Fuel consumption Ask for fuel consumption figures per hour and verify the accuracy of the supplier s figures against similar models in local use Choosing among suppliers There are many reasons for not purchasing from the lowest bidder However consider significant factors which reduce running costs such as Fuel consumption A model which has low fuel consumption may be cheaper to run over its whole working life than one with a higher fuel consumption b
6. C This means that if the temperature inside the box drops because of incorrect ratio of ice packs to red cell packs or due to a drop in environmental temperature there will be no colour change detected 36 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES MODEL T616 WHO CODE TD 01 PIS E6 09 E COMPANY NAME AND ADDRESS Pacific Transducer Corporation 2301 Federal Avenue Los Angeles CA 90064 United States of America Tel 1 310 478 11 34 Fax 1 310 312 0826 E SPECIFICATIONS Temperature range 40 C to 70 C External dimensions 9 x 10 cm External materials aluminium Weight 0 6 kg No per package 1 Test Reports CATR Z 9955 2 1978 Meets WHO UNICEF Standard E6 TR 2 E COMMENTS Includes polyethylene bag for protection against internal corrosion Also available in Fahrenheit Extra charts Part No 615 47CB 40 to 70 C Dry stylus operation Carrying case Part No 615 99 Important give entire product description and specify time temperature range in your order Shipping weight volume 0 91 kg 0 0013 cm Item Code Quantity Thermometer 616 WHO 1 Package charts 615 47CB 100 Carry case 615 99 1 CHAPTER 8 TEMPERATURE MONITORING DEVICES MODEL MR10 GT S E CODE TD 02 PIS E6 28 COMPANY NAME AND ADDRESS Hyoda Instruments Corporation 16 10 Kitahorie 1 Chome Nishi Ku Osaka 550 0014 Japan Telephone 81 6 65 38 12
7. Cap Alpha Avenue de l Europe Clapiers 34940 Montpellier Cedex 9 France Telephone 33 4 67 59 36 30 Fax 4 33 4 67 59 30 10 E mail info oceasoft com E SPECIFICATIONS Temperature range 40 C to 85 C Accuracy 0 3 C Measuring interval 1 255 mins Memory size 2048 measurements Size dxl 17 35 x 5 89 mm External materials Stainless steel Weight 3 30 g No per package 1 Power source internal Lithium battery Battery life available 5 years or 1 million measurements Test Report CEMAGREF and LCIE approved No WHO UNICEF Standard exists E USE Functions as a reusable cold chain monitor for use in vaccine blood refrigerators shipments and cold chain studies It displays and stores data that can be downloaded to a PC with MS Windows supported software Reading software available separately Shipping weight volume 1pk 1 kg 0 002 m Item Quantity Software cable 10 loggers 1 Logger 1 Interface cable 1 Portable controller 1 39 PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO BLOOD TIME TEMPERATURE INDICATORS BTTI Transport Card E MODEL NO 80 1017 E CODE TD 07 Blow Time Termperature ATTI Y thy rara e cado n sf beg SENDER PETIT Tan ra SiBinaa Syra ora ce inpri 421m iz uro Se Is JE 1 d A ng line calumr Lotes E rod a r cn aA Lom
8. THE BLOOD COLD CHAIN PROCESS Table 3 Maintenance of cold chain equipment Process components Example Input What goes in Information Determine the types and number of refrigeration equipment available their location and the specifications provided Materials Manufacturers instructions on maintenance of the equipment Elements Methods What makes the process work Develop Standard Operating Procedures for usage installation and maintenance of Blood bank refrigerators Freezers Cold boxes Platelet rotators Electric generators A maintenance schedule for all equipment needs to be developed and all individual schedules compiled into a single annual plan Equipment Refrigerators freezers platelet incubators and thermometers cleaning materials timers Personnel Identify who and how many people are needed to develop the SOPs put together the equipment registry and maintenance plan and who will be in charge of the daily temperature checks Environment Measurements What data will help keep this process working well Identify the location of each piece of equipment Numerical indicators should be identified that can monitor and evaluate the effectiveness of the process e g No of days equipment not maintained at correct temperature Service and repair actions per equipment Costs associated with repairs Years of service per equipment Donor Clinic Assis
9. ozonaction unep fr Internet www uneptie org ozonaction html appliances are still listed in the Product Information Sheets WHO EPI has decided not to accept the use of R600 or any other flammable gas for cold chain equipment recommendations of the TechNet subcommittee meeting on CFCs October 1995 and 1998 3 Manufacturers in developing countries continue to manufacture equipment with CFCs but many of them have already submitted CFC free samples for testing WHO Policy WHO BCT fully supports the recommendations of the Montreal Protocol and therefore recommends the following 1 Countries should know that the continued use of CFC equipment after 2010 is not in conformity with the Montreal Protocol and are urged to stop pur chasing equipment using CFCs forthwith 2 Managers of national blood programmes are urged to purchase blood cold chain equipment that meets WHO minimum performance specifications for the safe storage of blood components WHO will shortly publish such information 3 Manufacturers in developing countries are encour aged to switch to CFC free production as soon as possible 4 The maintenance staff of the Ministry of Health will require retraining on CFC free equipment if this has not already been done under the vaccine cold chain programme The Ministry of Health or the WHO country office has more information on the training courses available 5 Thereis need to adopt a systematic and coordinated
10. plan to replace CFC equipment within the blood transfusion service or Ministry of Health The policy has to be supported by a budget line that covers equipment procurement and a maintenance plan 59 6 This will be a good opportunity to develop a proper equipment inventory and maintenance plan not only for the blood cold chain equipment but also for other blood bank equipment In view of the foregoing there is evident need to assess the extent to which blood storage refrigerators and plasma freezers need to be replaced in a given country Annex 1 will assist countries in the development of a plan for the replacement of the equipment in line with the Montreal Protocol Recommendations to countries purchasing CFC free equipment When ordering new equipment blood cold chain managers should ensure that it is CFC free and that it meets or exceeds the minimum performance specifications for the blood cold chain published by WHO The following issues are also important Are tools locally available for the repair of CFC free equipment and have cold chain technicians been trained When the equipment arrives in the country Check that the compressors are marked with a 100 mm blue disk that helps draw the attention of repair technicians Check that blood cold boxes are marked with the recommended WHO emblem Keep an inventory of where the CFC free appliances are installed To the extent possible phase in the introduc
11. retrieval of packs is easier as the pack numbers are readable from a distance CHAPTER 9 ACCESSORIES TO THE BLOOD COLD CHAIN EQUIPMENT Blood packs When pre supplied trays are not provided it is necessary to design a system to hold the packs The key points in designing a tray for holding blood packs are 1 The material used must be strong and sturdy e g perspex or varnished wood 2 The design must allow the blood packs to stand straight Trays and pack holders provide for easier inventory management when about three quarters full 3 When full the tray should have a maximum weight of 3kg to allow for ease of carrying a single tray 4 The tray surface must be smooth to avoid any scratches to blood packs since they are made of plastic 5 The trays should be washable without damaging the construction material 6 The trays should be moisture resistant Plasma packs Plasma packs are different Plasma has to stay frozen and the best way to keep it frozen and for easier handling is for the packs to stay flat by putting the wet plasma pack in a pack holder The tray should still have a maximum weight of 3kg to allow for easier handling Once the packs are frozen they may be removed from these trays and packed in suitable cartons in the freezer which are properly labelled for ease of identification Manufacturers of plasma derivatives prefer single packs frozen flat for ease of handling 43 MODEL
12. reusable cold chain monitor for use in vaccine refrigerators shipments and cold chain studies The TTM is battery operated and small enough to fit inside a 35 mm plastic film container It stores data that can be downloaded by special cable to the serial port of a PC with MS Windows supported software Shipping volume 5 pks 555 cm Item Quantity Tiny TTM Type G 1x5 Software 1 1 IP 20 Interface cable 1 E MODEL TINY TYPE G IP68 E CODE TD 04 PIS 6 44 E COMPANY NAME AND ADDRESS Remonsys Ltd Distributor for Gemini Data Loggers UK Ltd The Stables Church Hanborough Witney Oxfordshire 0X29 8AB United Kingdom Telephone 44 1993 886996 Fax 44 1993 886997 E mail lewis autolog u net com SPECIFICATIONS Temperature range 40 C to 75 C Accuracy 0 2 C Measuring interval 0 5 secs to 4 hrs 48 mins Memory size 2048 readings Size L x B x H 70 x 60 x 50 mm External materials glass reinforced plastic Weight 150 g No per package 5 Power source battery 3 6 V Battery life available 2 years Test Report Univalle 1992 No WHO UNICEF Standard exists E USE Functions as a reusable cold chain monitor for use in vaccine refrigerators shipments and cold chain studies This version of Tiny TTM has a rugged enclosure It stores data that can be downloaded by special cable to the serial port of a PC with MS Windows supported software Shipping volume 0 001 cm
13. 1 Kwh per additional 10 litres gross volume at 43 C The temperature of the freezer section of solar powered equipment is typically below 10 C This is unsuitable for the medium to long term storage of fresh frozen plasma The key features for solar powered equipment are 1 Photovoltaic array Modules must meet the latest applicable specifications laid down by the Jet Propulsion Laboratory USA or Joint Research Centre Ispra Italy Array structures are designed to withstand wind loads of 200 kg per square metre and supplied with fixings for either ground or roof mounting Protection against the effect of lightning is provided for the battery charge regulator and other components The system is designed to enable continuous operation of the refrigerator and freezer loaded and including ice pack freezing during the periods of lowest sunlight in the year If other loads such as lighting are included in the system they shall operate from a separate battery set NOT from the battery set that supplies the refrigerator 2 Array to refrigerator cable This cable is sized so that when the array is at its maximum operating temperature and maximum output the voltage delivered CHAPTER 3 BLOOD BANK REFRIGERATORS is sufficient to charge the batteries at their maximum charge rate The manufacturer provides recommen dations for sizing the cable as a function of the distance from array to control box 3 Battery set Batteries sh
14. 3 isolated sections Rack is white PVC Metalecyne bladders separate tempered water from plasma bags Thawer has rocking agitation Temperature indicator Large digital thermometer Alarm systems Over temperature alarm and turn off when temperature reaches 38 C independent thermostat that turns off heaters at 42 C low water level alarm and heating turn off Senses plasma leaks Loading plasma packs Plasma packs are placed on the bladder and the lid closed Plasma bags and hands stay dry Temperature control Digital E SPECIFICATIONS Capacity in litres 12 Max no of plasma packs 6 x 450ml x 1000ml External dimensions in cm H x W x L 33 x 56 x 56 Gross volume litres 103 Weight kg 16 E PERFORMANCE DATA Full Min load load 16 mins 16 mins 6 bags 1 bag Thawing time 300ml bag of 250ml plasma Water bath temperature 37 C Noise level Low Free video and literature available CHAPTER 6 PLASMA THAWING EQUIPMENT E ENERGY REQUIREMENTS Rated voltage frequency 120 or 240V 50 60Hz Energy source AC Electricity Min voltage 105 VAC for 120 VAC unit 210 VAC for 220VAC unit Max voltage 135 VAC for 120 VAC unit 270 VAC for 220VAC unit E ADDITIONAL INFORMATION International standards equipment complies with CE UL 2601 1 CSA C22 2 No 601 1 FDA BK960012 Shipping volume gross weight 0 226 19 kg E SPARE PARTS FOR 10 UNITS ALL ACCESSORIES INCLUDED WITH UNIT Magne
15. 50Hz 58 60 60Hz 70 72 Energy consumption 115V 9 0A 230V 4 5A E ENERGY REQUIREMENTS Rated voltage frequency 110 120V 50 60Hz 220 240V 50 60Hz E ADDITIONAL INFORMATION International standards equipment complies with EN60601 1 EN61010 Shipping volume gross weight 2 5m 125kg PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO MODEL NOS PFS15 PFS42 PFS84 PFS396 E CODE PA 02 f CODE PA 03 f E COMPANY NAME AND ADDRESS Helmer 15425 Herriman Blvd Noblesville IN 46060 USA Tel 1 317 773 9073 Fax 1 317 773 9082 E mail sales helmerinc com www helmerinc com E FEATURES Design and construction Ball bearing motors circulation fans one piece perforated drawers and large diameter rollers for quiet operation Temperature indicator Not applicable Helmer offers four different flatbed platelet agitator models for different capacity needs not evaluated by WHO CHAPTER 5 PLATELET AGITATORS Alarm systems motion and power failure Independent built in motion alarms including adjustable time delay and separate power switch Power failure conditions signalled by the motion alarm after the delay period ends SPECIFICATIONS Capacity maximum no of platelet PSF15 15 packs 60ml or 240ml volume loaded PSF42 42 PSF84 84 PSF396 396 External dimensions in cm H x W x D PSF15 32x40x24 PSF42 35x46x36 PSF84 35x84x36 PSF396 157x94x68 PSF15 30 PSF42 60 PSF
16. Agitation at 1 5 inch 3 6 4 cm side to side stroke 65 75 strokes min Flatbed platelet agitators Specification Reference BTS PA IN 1 Purpose of Equipment To continuously agitate platelet concentrates in a temperature controlled environment at 22 C 5 C in an even suspension in a plasma bag Type of Equipment Flatbed agitator which uses electricity from the national grid Laboratory Test Procedure Standard Test Procedure BTS PA 1 Proc 1 Construction Open system with no doors and a strong base with handles Designed to hold a load of 300 ml random or apheresis type platelet packs of up to a litre or a mixture of both Design of Shelves Shelves are made of corrosion resistant material Easy loading and withdrawal of platelet packs Shelves cannot be pulled out in error The agitator holding the shelves is suspended in such a way as to ensure minimum noise for the life of the agitator Electrical Characteristics Nominal input voltage 220 240V 50Hz or 110V 60Hz Equipment meets electrical safety specifications such as that of IEC Internal Temperature Control Not applicable External Ambient Temperature Performs in an ambient temperature of 22 C 5 C Monitoring Motion of Agitator A motion alarm and power failure alarm Performance Agitation at 1 5 inch 3 6 4 cm side to side and 65 75 strokes min 24 BLOOD COLD CHAIN PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO PLATELET AGITATORS
17. B MODEL NO AGITATOR PFS42 INCUBATOR PC900 E CODE PA 01 f E COMPANY NAME AND ADDRESS Helmer 15425 Herriman Blvd Noblesville IN 46060 USA Tel 1 317 773 9073 Fax 1 317 773 9082 E mail sales helmerinc com www helmerinc com E FEATURES Design and construction Powder coated steel construction with stainless steel interior chambers Digital controls Temperature indicator LED temperature indicator operated by microprocessor PID digital controller Actual and set point temperatures can be displayed Alarm systems motion and power failure Agitators equipped with independent built in motion alarms adjustable time delay and separate power switch Incubators include power failure alarm with a keyed on off switch audible and visual high low temperature alarm and remote alarm contacts Thermographs Incubators include an inkless 7 day chart recorder with independent battery backup SPECIFICATIONS Capacity max no of platelet packs 60ml or 240ml volume loaded 42 External dimensions in cm H x W x D 79 x 67 x 70 Gross volume litres PC900 370 Weight kg 97 Helmer offers six different platelet incubators that can be matched with one or more platelet agitators Each Agitator Incubator provides chamber uniformity of 1 C GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES E PERFORMANCE DATA Full Half load load Stroke amplitude 3 8cm 3 8cm Stroke frequency
18. Duty for such items d additional costs for any accessories or spare parts needed such as temperature recorder charts and ink 11 2 Preparing tendering specifications Tender specifications for blood cold chain equipment should generally refer to the minimum performance specifications defined by WHO and should clearly describe the responsibilities of the contracting parties The following examples illustrate this point Inasupply only tender e g the supply of refrigerators or freezers be clear about the critical point of delivery For example is the supplier to be responsible for the delivery to the port of entry CIF or is it to deliver duty unpaid or duty paid DDU or DDP toa distribution point within the country Cold rooms are generally tendered on a supply and install basis This ensures that the supplier is entirely responsible for delivering installing and commissioning a cold room which complies with the tender specifications It is essential to write the Tender Documents so that the detailed responsibilities of both parties are clearly defined Formal tendering A formal tender procedure is one where details of the equipment to be bought their specifications and the quantities required are published using approved national and or international publications such as government gazettes or other widely read media The publication is an invitation to suppliers to submit bids for the tender or formal bind
19. E CODE BB 06 3 PIS B4 76M COMPANY AND ADDRESS Blow Kings 53 C Mittal Court Nariman Point Mumbai 400 021 India Tel 91 22 284 0120 Fax 91 22 283 1412 E mail blowkings vsnl com E SPECIFICATIONS Blood storage capacity 20 units Weight fully loaded 49 kg Weight empty 20 kg External surface material Plastic Internal lining material Plastic Insulation material Polyurethane Insulation thickness in cm 11 External dimensions H x W x L in cm 78 x 54 x 55 Internal dimensions H x W x L in cm 56 x 32 x 33 Blood storage dimensions H x W x Lin cm 46 x 23 x 19 Lid type and fixings Hinged No of ice packs required 52 No of ice packs supplied 52 E3 12 of 0 3 litre Cold life is 145 hrs when E5 19 0 4 litre is used Ice pack types E5 12 19 Robustness in drop test Fittings 2 Casing 5 Cold life without openings hrs at 32 C 145 hrs at 43 C Standards complied with Test reports ERTL W 2001 ENV 421 Meets WHO UNICEF Standard E4 CB 2 Shipping volume gross weight 0 26m 27 kg Minimum order 1 Cold life with blood calculated on basis of tests described in CRL A 9000 which established difference between performance with vaccine and blood 34 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES CHAPTER 8 devices 8 1 Overview Temperature monitoring devices are critical to the quality management of the blood cold chain Technolog
20. Examples Specific Spare Part Manufacturer Only usable on defined equipment Compressor or LED system for when the part is faulty temperature monitoring Safety Device Usually only available from Parts which protect other compo Special Fuses manufacturer nents from excessive stress by disintegrating at a predefined force Normal wear and tear Usually only available from Parts which are replaced because of Gaskets door liners manufacturer wear and tear Consumables Usually only available from These parts are utilized whenever the Temperature recorder charts manufacturer equipment is operational or data loggers ink General spare part Universally available Spare part used universally on any Light bulbs switches nuts bolts equipment or with minimal modification fuses refrigerant gas Figure 3 Priorities for the purchase of spares Situation Priority Are qualified in house or external NO maintenance staff available a failure of the part endanger NO 1 products equipment or staff 1 YES Is the rate of failure high M 2 1 YES NO Is the part relatively cheap to buy 3 J YES Because of frequent failure is it NO gt 4 necessary to redefine the spare YES Can the part be used on different NO gt 5 equipment general spare part YES 10 3 Procuring essential spares for repairs and preventive maintenance An important aspect in the management of spares
21. RH RPM SOP TTM V amp B VAC VDC WHO International Electricity Council International Standards Organization kilogramme s kilovolts Kilowatt hours Light emitting diode itres metre maximum minimum millimetre Number not tested Personal Computer pack Product Information Sheets of WHO S Expanded Programme on Immunization Polyvinyl chloride plastic Relative humidity Revolutions per minute Standard Operating Procedures Time Temperature Monitor volt WHO Department of Vaccines and Biologicals voltage alternating current voltage direct current World Health Organization vii B Glossary Cold life ofa blood transport box the amount of time from loading a box with frozen ice packs until the warmest internal temperature reaches 10 C given a constant external temperature of 43 C The door to the unit is kept closed Compressor starting test to assess the minimum voltage required for a compressor to start Cooling down time the time taken by the equipment to cool down effectively a full load of blood or plasma to acceptable temperature limits see relevant WHO minimum performance specifications This is important to know since the faster the equipment is able to cool a load down the faster the products reach a safe storage temperature If the cooling down time is too long it may be necessary to reduce the load by half or a quarter De rating a generator s performance is affected
22. ambient temperature 154 V Minimum compressor starting voltage at operating temperature 154 V CHAPTER 3 BLOOD BANK REFRIGERATORS E ADDITIONAL INFORMATION Equipped with dual refrigeration system International standards equipment complies with ISO 8187 EN 28187 Shipping volume gross weight 1 71 3 210 kg ACCESSORIES Temperature recorder Recorder paper 100 pks Recorder pen Blood bag baskets total capacity 20 pks E RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Compressor 1501950 4 pks Evaporator coil 1801062 2 pks Evaporator fan motor 2501283 2 pks Condenser fan motor 2501283 2 pks Filter drier 3853070 4 pks Condensate heater 5502150 2 pks Service valve 7608558 4 pks Control unit 5201350 2 pks Transformer 5201300 2 pks Thermostat 4001410 2 pks Lamp 7700058 4 pks Contactor 6401000 2 pks Relay 8705006 1 pk Relay base 8705007 1 pk Door switch 6501540 2 pks Door gasket 5002115 2 pks t f MODEL NO BBR25SI 2A E CODE BR 04 4A E COMPANY NAME AND ADDRESS Jewett Refrigeration Inc 275 Aiken Road Asheville NC 28804 USA Tel 1 828 658 2845 Fax 1 828 645 9466 www jewettonline com E FEATURES Type of internal lining of the cabinet Stainless steel 13 Description of shelves and drawers 6 stainless steel drawers Doors Triple pane heated glass with heated frame Lockable Internal air cooling mechanism Blower coil Automa
23. any blood cold chain equipment If the supplier is expected to train users in the installation maintenance and servicing of the equipment the purchasing organization will need to allow for this in the budget The installation of cold chain equipment is relatively easy if the manufacturer s instructions are followed precisely Many blood transfusion services and large hospitals employ a technician with responsibility for the installation and training of users in the maintenance of cold chain equipment and who generally receive direct supervised training from equipment suppliers This is a much cheaper and more practical approach Backup support and spare parts It is important to ensure that suppliers of equipment are able to provide local back up support in case of breakdown of the equipment The location of the supplier is thus crucial If the supplier is outside the country for example each time there is an equipment breakdown which cannot be dealt with locally the organization will have to meet the costs of the refrigeration engineer to repair the equipment and arrange the importation of spare parts This can be avoided with a careful analysis of suppliers When purchasing equipment it is important to obtain a reasonable number of spare parts for the equipment at the same time However in order to avoid holding large stocks of spare parts that may not be needed in the short to medium term the range and quantity of the spare
24. bag i e in a double bag in order to provide better protection The most efficient cooling is achieved when the coolant pouch is in direct contact with the blood or platelet pack However the most important point is that the efficiency of the coolant depends on the insulating capacity of the blood transport box The coolant is reusable and therefore cost effective and eliminates the need for ice and water which can be messy It provides temperature stability between 20 and 24 C in hot or cold climates and is therefore useful in the following situations 1 To rapidly cool whole blood from 37 C to 20 C 2 To assist to maintain the temperature of whole blood at approximately 20 C during transport prior to processing the components 3 To provide temperature stability during platelet storage at 20 to 24 C and 4 For the transportation of platelet packs between the laboratory and patient recipient Blood transport boxes short cold life Specification Reference B4 BC1 Purpose of Equipment To carry whole blood from individual donors to blood bank or from blood bank to point of use Laboratory Test Procedure Standard Test Procedure B4 PROC 4 Robustness Fittings 2 casing 3 see ratings in test procedure Net Capacity for Blood Bags 1 4 litres 2 bags Maximum Weight Permitted 6 kg Cold Life Maintenance of under 10 C for minimum 30 hrs in ambient temperature of 43 C Maximum Ice Melting Rate Mo
25. cold chain equipment or accessories to participate in the Project by providing equipment to be laboratory tested and evaluated in the field The products featured in this Guide are from manufacturers that wished to contribute to this activity The results of the evaluation enabled WHO to develop the appropriate laboratory test procedures that meet the environmental and technical challenges posed in developing countries Some of the findings of this evaluation are outlined below 1 Appropriate equipment and spares are frequently not readily accessible 2 High ambient temperatures and or humidity in some countries affect the maintenance of temp eratures by the equipment in the blood bank setting as the door of the cold chain equipment is frequently opened Laboratories are not often air conditioned 3 Power cuts and voltage fluctuations affect the performance of the compressor and temperature monitoring devices 4 Temperature monitoring devices are not often in place particularly because domestic type equipment is commonly used for storage of blood components WHO minimum performance specifications for blood cold chain equipment have been determined for a wide range of equipment These specifications complement the relevant international standards and are intended to assist manufacturers in developing countries to be able to produce appropriate equipment locally thus making this equipment and spare parts readily accessible and ava
26. health care programmes to improve management of the blood cold chain This publication provides specific guidance in the selection and procure ment of blood cold chain equipment and accessories As mentioned in the copyright notice WHO does not endorse or recommend manufacturers or their products listed in this publication over those not mentioned The products featured are those that i were submitted by manufacturers that wished to participate in a WHO project to develop minimum performance specifications for all essential equipment and accessories needed for an effective blood cold chain and that ii met the WHO minimum performance specifications after laboratory testing and field evaluation The WHO Office of Procurement Services procurement who int can be consulted to provide up to date information on the procurement of medical equipment and supplies B Products featured in this guide Equipment and Model Code Manufacturer Page Blood Refrigerators Standard Electric BR320 01 2 Dometic Luxembourg 11 BB510 BR 02 2a Huurre of Finland 12 BB710 BR 03 2a Huurre of Finland 13 BBR 25SI 2A BR 04 4a Jewett Refrigeration USA 13 CT1 2A BR 05 2a Jewett Refrigeration USA 14 Solar Powered VC65F BR 06 1b Dulas Ltd UK 16 MB50DC BR 07 1b Dometic Luxembourg 17 Ice lined MB50AC BR 08 1c Dometic Luxembourg 18 MRB 2000 BR 09 1c Dometic Luxembourg 19 Plasma Freezers FR160 PF 01 3 Dometic Luxembourg 21 CTF406 2A PF 0
27. literature available 28 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES E ENERGY REQUIREMENTS Rated voltage frequency 120 or 240V 50 60Hz Energy source AC Electricity Min voltage 105 VAC for 120 VAC unit 210 VAC for 220VAC unit Max voltage 135 VAC for 120 VAC unit 270 VAC for 220VAC unit E ADDITIONAL INFORMATION International standards equipment complies with CE UL 2601 1 CSA C22 2 No 601 1 FDA BK960012 Shipping volume gross weight 0 153m 12 kg E SPARE PARTS FOR 10 UNITS ALL ACCESSORIES INCLUDED WITH UNIT Magnetic pump Board Heater E MODEL NOS DH8 E CODE 04 E COMPANY NAME AND ADDRESS Helmer 15425 Herriman Blvd Noblesville IN 46060 USA Tel 1 317 773 9073 Fax 1 317 773 9082 E mail sales helmerinc com www helmerinc com E FEATURES Internal lining of equipment Stainless steel water tank External material Powder coated steel Alarm systems for safe plasma thawing Adjustable high temperature alarm with visual and audible indicators The thawing basket raises out of the water automatically when a high alarm occurs Loading and retrieval of plasma packs Plasma packs are loaded into an overwrap bag which is placed immediately into the basket assembly while the basket is in the UP position out of the water The cycle start button automatically lowers the basket into the water When the thawing cycle is complete an aud
28. litres 70 Weight kg 60 E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 3 6 3 8 Internal temperature maximum 4 5 4 8 Hold over time 6 3hrs 3 5hrs 2 8 hrs Cool down time 37 1hrs 4 6 Energy consumption 1 68 Kwh 24hr E ENERGY REQUIREMENTS Rated voltage frequency 230 VAC 50 60 Hz Energy source AC Electricity Minimum compressor starting voltage at 32 C ambient temperature 132 V Minimum compressor starting voltage at operating temperature 132 V E RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Compressor 230 VAC 50Hz 296 9701 12 1 Compressor 115 VAC 60Hz 296 9701 13 1 Fan 12 VDC 296 9710 65 1 Fan 230 VAC 296 9759 53 1 Drier 296 0945 02 1 Main board 296 9764 02 1 ADDITIONAL INFORMATION International standards equipment complies with 73 23 EEC and 93 68 EEC Shipping volume gross weight 0 73m 78 kg E MODEL NO MRB2000 920 6811 2 E CODE 09 1 E COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 4 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic lu CHAPTER 3 BLOOD BANK REFRIGERATORS E FEATURES Type of internal lining of the cabinet PVC Description of shelves and drawers 2 wire baskets Doors Lockable lid Internal air cooling mechanism Yes Internal lighting No Temperature indicator
29. medical equipment may be obtained from Department of Procurement Services World Health Organization 1211 Geneva 27 Switzerland E mail procurement who int World Health Organization 2002 All rights reserved Publications of the World Health Organization can be obtained from Marketing and Dissemination World Health Organization 20 Avenue Appia 1211 Geneva 27 Switzerland tel 41 22 791 2476 fax 41 22 791 4857 e mail bookorders who int Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to Publications at the above address fax 41 22 791 4806 e mail permissions who int The mention of specific companies or their products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned Errors and omissions excepted the names of proprietary products are distinguished by initial capital letters The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned Errors and omissions excepted the names of
30. of 10 C or above As soon as 10 C is exceeded the first window starts to turn blue If the temperature remains above 10 C or at every successive exposure to this temperature the blue colour will migrate through windows 1 2 and 3 The higher the temperature the faster the blue colour will spread through these windows Window 4 will start to show traces of blue immediately the temperature in the container exceeds 17 C The coloration in the windows is easy to observe and although coloration may stop is irreversible Use The is not intended to replace existing quality assurance measures for the safe transportation of blood components It is a simple tool to assist personnel handling blood components to decide to use or discard a particular blood consignment In this way the BTTI transport card contributes to the goal of increasing the safety of the global blood supply in line with WHO recommendations related to the blood cold chain The BTTI will be useful to monitor the temperature of whole blood or red cell suspensions in many different situations 1 Storage in cold boxes in the case of breakdown in electricity or other powered supply 2 Shipment using blood transport boxes from one blood bank to another 3 Movement of blood from the blood bank to the bedside 4 Return of unused blood from the point of potential use to the hospital blood bank N B The BTTI will not indicate temperatures below 10
31. onto the PC to download the temperature recordings made The records may thus be printed and kept as a permanent record Temperature data loggers provide a very accurate record of the temperature of a cabinet or other environment Their major drawback is the need for a computer However in view of the increasing use of computers data loggers may be the best investment for the future There are other devices that simultaneously monitor the temperature of several pieces of blood storage equipment The original version is made up of wires 35 connected from an enabling temperature monitoring port at the back of the blood refrigerator leading to a remote device able to display a warning light green to red and or alarm sound The device is placed at a site that is permanently manned e g the hospital switch board Several pieces of blood storage equipment may be wired in this way The devices can also warn of a power failure to the equipment being monitored Finally there are new devices for monitoring up to 16 blood bank refrigerators simultaneously Temperature probes are connected from an enabling temperature monitoring port at the back of the blood refrigerator leading to a multi temperature data logger device The device is permanently connected to a PC The information can thus be continuously displayed and automatically saved and printed if required The software enables an alarm to be set off if temperature settings are excee
32. over time iii The time taken to cool down a load of blood or plasma packs to the temperature of the refrigerator or freezer respectively is referred to as the cool down time faster the cool down time the earlier the blood components attain the desired temperature and the safer the blood The cool down time depends on the temperature of the components when introduced into the cold chain equipment and on the capacity of the equipment to achieve the desired temperature In order to achieve a faster cool down time components should be at or below room temperature and the quantity of blood components introduced at any one time should be limited There is considerable variation in the cooling down time of equipment between different manufacturers The blood cold chain manager should therefore select equipment with an appropriate cooling down time to suit the volume of blood handled iv Performance during voltage fluctuations In some countries the mains voltage may vary due to techno logical constraints or other environmental factors CHAPTER 1 INTRODUCTION TO THE WHO BLOOD COLD CHAIN PROJECT such as lightning The performance of the equip ment e g compressor at low or high input voltage needs to be assessed Similarly the stability of sensitive electronic equipment such as temperature monitoring devices when voltage fluctuates should also be assessed v Any equipment that stores blood components should contain
33. parts relates to equipment procurement Procurement of blood cold chain equipment is best achieved funds permitting through buying in bulk from a single source at a given time using tender procedures See Chapter 11 This has three advantages Firstly the optimal level of essential spares per given quantity of equipment can be bought to cover all the equipment Second main tenance is more cost effective and thirdly inventory management of the spares is easier While standard ization has advantages it may not be reliable to procure all equipment from a single national source for example due to potential instability of a given supplier e g political or economic As a general rule spare parts to the equivalent of 1096 of the value of the equipment should be ordered at the same time A regular review of the national needs for blood cold chain equipment is therefore critical to ensure that optimal spare parts are available ensuring a cost effective preventive maintenance and repair service This Guide therefore provides the manufacturers list of recommended spare parts where available for all equipment listed 10 4 Common problems in managing an inventory of spare parts The lack of spare parts in many developing countries may be attributable to the following causes Diversity of equipment Usually a result of uncoor dinated procurement of equipment and or a lack of harmonization in donation of equipment 46 BLOOD COLD
34. parts required need careful assessment A larger stock will be required of items that wear out relatively quickly such as hinges evaporators and door gaskets than those that last longer such as compressors Manufacturers should therefore be requested to provide a list of recommended spare parts that will be required over a five year period Spare parts are generally centrally stored under the care of the technician who has national responsibility for the maintenance of cold chain equipment This assists in controlling wastage and theft and enables the technician to plan for replacement items Commissioning Commissioning i e installation and certifying the equipment ready for use reassures the client that the equipment is working properly At least 10 of the payment due should be withheld until a full commissioning test has been completed satisfactorily The equipment should be validated as part of the quality management process in the blood bank i e the test procedure should run at least 48 hours Cooling phase alarms temperature monitoring and temperature controls should be included in the test Guarantee The supplier generally provides a guarantee for the equipment This guarantee is generally in one of two forms 1 An initial guarantee of the entire equipment for period of between 6 months to 2 years or more This guarantee may be for replacement or full repair costs 2 Following this period the supplier may
35. test conditions Temperature all temperatures are plus unless otherwise indicated Voltage fluctuation test to assess the stability of the electronic temperature control devices when exposed to voltage fluctuations B Preface his is the first WHO publication dedicated to assisting managers of blood programmes to select and procure equipment and devices for the blood cold chain The safe storage and transportation of blood and blood products is an integral component of the WHO strategy for blood safety It is estimated that approximately 2 of blood that has been found safe to transfuse may be discarded for various reasons This percentage varies depending on the management of the inventory and the effectiveness of the blood cold chain and is a waste of a scarce and valuable resource WHO recognizes that there are differences in the handling of blood and vaccines in the field These differences required the development of a blood cold chain that would follow the same principles as the vaccine cold chain but be specific to blood and blood products The temperature and volume of blood during storage the short life span of blood components and their movement to and from the blood bank invariably require equipment with different specifications The blood cold chain has therefore developed in parallel and at a different pace to the vaccine cold chain This publication aims to provide not only WHO minimum performance specifica
36. that equipment with the correct power rating is purchased or acquired If equipment with a different power rating is acquired an appropriate transformer will be needed to step up or down the power supply to the equipment Equipment receiving power in this way does not perform as well as when it is plugged into the recommended power source Other issues to consider include an adequate number of power sockets for blood cold chain equipment In order to reduce the risk of fire adaptors should not be used 50 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Figure 4 Example of a tender Item 1 Blood bank refrigerators Specifications Quantity 317 units Capacity To accommodate minimum 300 standard blood bags each of 450 ml capacity Refrigeration system a CFC free refrigerant gas and insulation b Fan circulating cooling system Internal construction Stainless steel minimum 22 gauge 5 6 drawers rollout type stainless steel approx 22 gauge External construction a Corrosion resistant sheet at least 1 mm thickness b Locking castors Internal temperature control a Electronic temperature control operational 4 C range 2 C to 6 C with setting accuracy 1 C b Probe to be immersed in liquid medium with similar viscosity to blood 10 glycerol solution Hold over time of at least 30 min on full load d Cooling down time of a m
37. thawing of up to four or eight bags simultaneously Only Model DH8 was evaluated by WHO CHAPTER 6 PLASMA THAWING EQUIPMENT 1 PID Proportional Band Integral Function Derivative Function RTD Resistance Temperature Detector 29 CHAPTER 7 and coolants DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT Blood carriers The data on blood transport has been compiled in collaboration with the WHO Department of Vaccines and Biologicals V amp B on the basis of tests to determine that the equipment meets WHO UNICEF specifications All the cold boxes and carriers in this chapter also appear in Each blood transport Section E4 cold boxes and box requires frozen ice packs to ensure an acceptable cold life vaccine carriers of the WHO Expanded Programme on Immunization Product Information Sheets PIS 2000 Edition The code numbers remain standard with a different prefix to indicate the section for example E4 72 M describes the Apex Continental carrier as a vaccine carrier while B4 72 M gives its performance figures as a blood carrier Each blood transport box requires frozen ice packs in order to ensure an acceptable cold life The blood transport boxes produced below from the PIS also show the type and number of ice packs required It is important to purchase always a second set of ice packs for each model because of inevitable losses and also to ensure a constant set of frozen ice packs for routine
38. to be familiar with their products by acquiring a catalogue with specifications and a price list Reflect carefully on the list in relation to projected needs and WHO minimum performance A quality product is durable and gives trouble free service specifications There are variations within each class of equipment e g in user friendliness or features that make one piece of equipment easier to use than another Examples of desirable features for blood bank refrigerators include 1 Castors or wheels that enable the equipment to be moved easily 2 Glass fronted doors that allow easy viewing of blood stocks 3 Door lighting that further improves the view of the blood stocks in the refrigerator 4 Door open alarm facility that alerts users to close the door immediately after use 5 Door lock which improves the security of the contents of the equipment Quality A history and survey of existing equipment will give an indication of which manufacturers produce quality products Many colleagues in the industry can be 48 selecting and procuring blood cold chain equipment consulted to share their experiences on the quality of different types of cold chain equipment Quality is a major issue for the following reasons 1 A quality product is generally durable and gives a trouble free service 2 The equipment maintains its performance and appearance 3 Although a quality product is often more expensive its lo
39. type and number of spare parts which may be needed during the first five years of operation of solar powered equipment need careful assessment WHO and UNICEF for example recommend that the minimum following spares kit be ordered for every 10 solar refrigerators ordered Photovoltaic modules 1 Battery charge regulators 2 Battery sets 1 Array cables 1 Compressor or complete cooling unit as recommended by the manufacturer 1 Spare compressor electronic control cards 3 Thermostat or temperature control cards 3 Condenser fans if used 2 1 see publication WHO EPI LHIS 97 06 15 Supplier In order to ensure a reliable solar system it is most important that solar powered blood bank refrigerators are supplied with the solar system to match the equip ment by a WHO approved supplier This ensures a reliable system appropriate for the environment and energy demands of the equipment Instructions manuals Manuals shall be provided with each refrigerator with clear descriptions for users and electricians of simple daily weekly and monthly maintenance tasks periodic preventive maintenance checks diagnostic and repair procedures temperature adjustments installation procedures WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Solar powered blood bank refrigerators Specification Reference BTS RFS 3 Purpose of Equipment A refrigerator for the storage of whole blood red cell packs in a blood bank Type of Equipment Compres
40. type of platelet packs handled Capacities vary from 10 to over 300 random platelet donor packs and proportionally less apheresis donor platelet concentrates Larger agitators have incubators and are usually floor models Take this point into consideration when planning floor space within the laboratory 2 What type of agitator do you want elliptical or horizontal Horizontal flat bed agitators are preferred because bags are not stored packed together which allows an adequate gas interchange between the bag and the surrounding air 3 Should you buy an incubator Platelets should be kept between 20 and 24 C You need a 24 hour monitored air conditioned room in order to provide this environment within the laboratory Incubators provide this advantage with added safety features such as alarms and temperature data recorders 4 Reliability Are repair facilities and spare parts available for the agitator to be purchased 5 Temperature monitoring Do you have a fixed temperature display and alarm system 6 Price Which agitator meets requirements 1 5 at the lowest cost 7 Do you need user and service manuals in the official language of your country 8 Training Are the users and those in charge of maintenance of the equipment properly trained Checklist for selecting a plasma thawer 1 What size of plasma thawer do you need They vary in size from 4 to 12 units of plasma at the same time Plasma thawers should han
41. voltage 73 23 EEC and 93 68 EEC code AB1 Minimum compressor starting voltage at 32 C ambient temperature 158 V Minimum compressor starting voltage at operating temperature 158 V Shipping volume gross weight 1 67m 214 kg 11 E RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Ref Quantity Door switch 296 9821 01 1 Sensor 296 9804 10 2 Motorfan 296 9759 02 1 On Off key 296 8954 11 1 Thermostat 292 2007 17 1 Main board 296 9769 00 1 Compressor 296 9701 15 1 Drier 296 0945 03 1 E MODEL NO BB 510 E CODE BR 02 2A E COMPANY AND ADDRESS Huurre Group Oy P O Box 127 33101 Tampere Finland Tel 358 20 55 55 11 Fax 358 20 55 55 288 E mail export huurre com www huurre com E FEATURES Type of internal lining of the cabinet Stainless steel Description of shelves and drawers 5 stainless steel drawers Doors Solid outer door plus perspex inner door Lockable Internal air cooling mechanism Fan air cooling Automatic defrosting Internal lighting Interior light 1 x 36 W Temperature indicator and alarm system Digital display to 1 C Mains power failure alarm High low temperature audible and visual alarms Battery back up Thermographs See accessories Interface for Remote Temperature Monitoring Yes E SPECIFICATIONS Internal capacity litres 315 Maximum no of blood or plasma packs loaded 60 x 450 ml blood bags External dimensions in cm H x W x
42. 1 2 On Off key 296 8954 11 1 Magnetic valve 296 9761 51 1 Main board 296 9769 00 1 21 MODEL NO CTF406 2A E CODE 02 2 E COMPANY NAME AND ADDRESS Jewett Refrigeration Inc 275 Aiken Road Asheville NC 28804 USA Tel 1 828 658 2845 Fax 1 828 645 9466 www jewettonline com E FEATURES Type of internal lining of the cabinet Stainless steel Description of shelves and drawers 3 stainless steel drawers Doors Lockable door Internal air cooling mechanism Blower coil Automatic defrosting Internal lighting Not applicable Temperature indicator and alarm system Digital display to 1 C Mains power failure alarm high low temperature audible and visual alarms Battery back up Thermographs Optional Interface for Remote Temperature Monitoring Optional SPECIFICATIONS Internal capacity litres 153 Maximum no of plasma pks loaded 88 x 300 ml External dimensions in cm H x W x L 49 x 49 x 55 Gross volume litres 0 52 m Weight kg 95 E PERFORMANCE DATA Full Quarter Empty load load Internal temperature minimum 36 371 C Internal temperature maximum 27 5 C 28 0 Hold over time 3 hrs 3 hrs Cool down time 18 hrs 8 hrs Energy consumption E ENERGY REQUIREMENTS Energy source AC Electricity Rated voltage frequency 230V 50Hz 115V 60Hz Minimum compressor starting voltage at 32 C ambient temperature Minimum compressor starting voltage at operati
43. 2 2 Jewett Refrigeration USA 22 Platelet Agitators PFS42 Agitator in PA 01 i Helmer USA 24 PC900 Incubator Helmer USA 24 Flatbed Platelet Agitators PFS15 PA 02 f Helmer USA 25 PFS42 PA 03 f Helmer USA 25 PFS84 PA 04 f Helmer USA 25 PFS396 PA 05 f Helmer USA 25 Plasma Thawers CytothermDR PT 01 Phototherm USA 27 CytothermD4 PT 02 Phototherm USA 27 Cytotherm4T PT 03 Phototherm USA 28 DH8 PT 04 Helmer USA 29 Blood Transport Boxes MT25E CF blue BB 01 4 PIS B4 05M Dometic Luxembourg 31 3504 38 CF BB 02 1 PIS B4 18M Thermos USA 32 55 CF BB 03 2 PIS B4 57M Blow Kings India 32 MT12E CF BB 04 3 PIS B4 62M Dometic Luxembourg 33 ICBB 13F BB 05 3 PIS B4 72M Apex Continental Ltd India 33 CB 20 CF BB 06 3 PIS B4 76M Blow Kings India 34 Temperature Monitoring Devices T615 Recording thermometer TD 01 PIS E6 09 Pacific Transducer Co USA 37 AR10 GT S Recording thermometer TD 02 PIS E6 28 Hyoda Instuments Co Japan 37 Tiny TTM Type G IP68 data logger TD 03 PIS E6 43 Remonsys Ltd UK 38 Tiny TTM Type G data logger TD 04 PIS E6 44 Remonsys Ltd UK 38 Autolog 2000TM data logger TD 05 PIS E6 47 Remonsys Ltd UK 39 Thermo tracer data logger TD 06 PIS E6 48 Ocea Soft France 39 80 1017 3M TD 07 3M Berlinger amp Co AG CH 40 Accessories FF500 4R voltage regulator for refrigerators VR 01 Advance Galatrek UK 44 Equipment laboratory tested and evaluated in the field indicates that field test result
44. 84 100 PSF396 1000 PSF15 12 PSF42 24 PSF84 39 PSF396 114 Gross volume litres Weight kg E PERFORMANCE DATA Full Half load load Stroke amplitude 3 80m 3 8cm Stroke frequency 50Hz 58 60 60Hz 70 72 Energy consumption PSF15 115V 0 2A 230V 0 4A PSF42 115V 0 2A 230V 0 4A PSF84 115V 0 2A 230V 0 4A PSF396 115V 3A 230V 2A E ENERGY REQUIREMENTS Rated voltage frequency 110 120V 50 60Hz 220 240V 50 60Hz B ADDITIONAL INFORMATION International standards equipment complies with EN60601 1 EN61010 Shipping volume gross weight PSF15 19m 16kg PSF42 19m 27kg PSF84 90m 44kg PSF396 2 83m 164kg 25 Plasma 1 Equipment CHAPTER 6 DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT A plasma thawer is a water bath designed to offer rapid and safe defrosting of frozen plasma It achieves this through the agitation of the plasma in a bath at 37 C or by directing a stream of warm water to the plasma pack Defrosting from 30 C to 0 C is achieved within approximately 15minutes The plasma packs may be introduced at random or as a batch depending on the model selected A plasma thawer achieves a uniform and quality standard of defrosted plasma for transfusion or other use The limitation is the risk of leakage of plasma from a cracked plasma pack Unless a dry type of plasma thawer is selected or the plasma packs are packed in leak proof plastic during thawin
45. 91 Fax 81 6 65 39 26 17 E mail hyoda co axel ocn ne jp SPECIFICATIONS Temperature range 30 C to 50 C Hours per cycle 24 hrs External dimensions in cm 28 5 x 10 External materials aluminium Weight 15 kg No per package 1 Test Reports CATR A9105 1985 Meets WHO UNICEF Standard E6 TH 2 COMMENTS Capillary tube at the bottom of the case Length of capillary 3m Sensor of probe dxl 12 mm x 150 mm Thread connection 1 2 NPT Minimum order 1 Shipping volume gross weight 1 pk 0 100 m 15 kg Item Quantity Recorder 1 Nibs 10 Ink blue or red 10 x 50cc Chart paper 1000 sheets 31 PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO TEMPERATURE DATA LOGGERS E MODEL TINY TYPE G E CODE TD 03 PIS E6 43 COMPANY NAME AND ADDRESS Remonsys Ltd Distributor for Gemini Data Loggers UK Ltd The Stables Church Hanborough Witney Oxfordshire 29 8AB United Kingdom Telephone 44 1993 886996 Fax 44 1993 886997 E mail lewis autolog u net com E SPECIFICATIONS Temperature range 40 C to 75 C Accuracy 0 2 C Measuring interval 0 5 secs to 4 hrs 48 mins Memory size 1800 readings Size dxl 30 x 50 mm External materials plastic case Weight 0 05 kg No per package 5 Power source battery 3 6 V 1 2AA Battery life available 2 years Test Report Univalle 1992 No WHO UNICEF Standard exists E USE Functions as a
46. CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Equipment is too old and spares no longer accessible Capital for the timely replacement of old equipment not budgeted for or available Limited local market for the equipment Uneconomic to hold a realistic spares inventory Import currency restrictions Management of the inventory and its security Poor control monitoring and distribution of the spares often results in unnecessary shortage of spares CHAPTER 10 EQUIPMENT MAINTENANCE More reading on the management of spare parts and preventive maintenance will be available in the WHO learning materials on the Management of the Blood Cold Chain This Guide does not list all possible spare parts Each manufacturer listed however can provide a list of essential spare parts for a given quantity of equipment purchased The WHO Procurement Services can also provide guidance on the procurement of all medical supplies fax 4122 791 4196 e mail procurement who int 41 CHAPTER 11 The purchase of cold chain equipment should be considered as a long term investment The equipment should last for many years and give a good return of service if rigorous selection criteria have been applied 11 1 Selecting manufacturers There are many manufacturers of cold chain equipment that specialize in blood storage equipment There may also be local companies that produce such equipment It is important
47. Down Time A full load of blood packs at 37 C takes a maximum of 8 hrs for all the packs to reach below 6 C Temperature Monitoring Digital temperature LED display with 0 1 C graduation Temperature recording device Visual and audible alarm system indicating unsafe temperatures Battery back up for alarm and temperature recording device Facility for remote alarm contact I MODEL NO MB 50AC CF 991 2350 01 E CODE 08 1 E COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 4 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic lu E FEATURES Type of internal lining of the cabinet Polyethylene Description of shelves and drawers 2 wire baskets Doors Lid Internal air cooling mechanism Fan Internal lighting No Temperature indicator and alarm system Digital display with alarm functions Thermographs Optional in the unit Interface for Remote Temperature Monitoring No SPECIFICATIONS Internal capacity litres 14 4 Maximum no of blood bags loaded 32 x 450 ml blood bags The hold over time and cool down times were measured at 43 C ambient at full load This means that the lower the ambient temperature the better the performance of the equipment 18 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES External dimensions in cm H x W x 1 83 x 82 x 98 Gross volume
48. E AND ADDRESS Dulas Ltd Dyfi Eco Parc Machynlleth Powys SY20 8AX ou United Kingdom ae Tel 44 1654 70 50 00 Fax 44 1654 70 30 00 E mail solar dulas org uk Internet www dulas org uk E FEATURES Type of internal lining of the cabinet Aluminium ripple finish Description of shelves and drawers 2 baskets each with 3 shelves Doors Solid lid Internal air cooling mechanism Nil Internal lighting Nil Temperature indicator and alarm system Digital temperature display at 1 C Integrated high low temperature alarm and max min temperature memory Thermographs Temperature recorder and charts Interface for Remote Temperature Monitoring Nil SPECIFICATIONS Internal capacity litres Refrigerator 24 blood pks Freezer 16 6L ice packs Maximum no of blood pks loaded 24 450 ml External dimensions in cm H x W x L 97 x 93 x 80 Gross volume litres Refrigerator 68 Freezer 25 Weight kg 115 kg The hold over time and cool down times were measured at 43 C ambient at full load This means that the lower the ambient temperature the better the performance of the equipment 16 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 3 8 C Internal temperature maximum 4 3 C Hold over time 2 42 hrs Cool down time 8 75 hrs Energy cons
49. L 205 x 60 x 70 Gross volume litres 380 Weight kg 140 kg E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 3 1 2 9 C Internal temperature maximum 5 3 C 5 6 Hold over time 30min 29min 29min Cool down time 5 5 hrs Energy consumption 9 86 Kwh 24h E ENERGY REQUIREMENTS Energy source AC Electricity Rated voltage frequency 230 V 50 Hz International standards equipment complies with ISO 8187 EN 28187 Mininum compressor starting voltage at 32 C ambient temperature 154 V Minimum compressor starting voltage at operating temperature 154 V E ADDITIONAL INFORMATION Shipping volume gross weight 1 26m 160 kg International standards equipment complies with ISO 8187 EN 28187 ACCESSORIES Temperature recorder Recorder paper 100 pks Recorder pen Blood bag baskets total capacity 15 pks RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Compressor 1501950 2 pks Evaporator 1801020 2 pks Evaporator fan motor 2501283 2 pks Condenser fan motor 2501283 2 pks Filter drier 3853070 2 pks Condensate heater 5502150 2 pks Service valve 7608558 2 pks Control unit 5201350 2 pks Transformer 5201300 2 pks Thermostat 4001410 2 pks Lamp 7700058 2 pks Contactor 6401000 2 pks Relay 8705006 1 pk Relay base 8705007 1 pk Door switch 6501540 2 pks Door gasket 5002113 2 pks 12 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PR
50. MITATIONS OF THE EQUIPMENT In many developing countries blood transfusions may take place in health centres or district hospitals that do not have access to the national electricity grid In some health facilities the electricity generator for a health centre may only be used after sunset In these situations blood bank refrigerators need to be able to maintain blood at between 2 to 6 C 24 hrs of the day In countries with a sufficient quantity of sunshine through out the year solar powered refrigerators may be the answer A flow chart in Chapter 11 provides guidance on where solar refrigeration may be recommended The design of the cabinet of the compression refrigerator powered by solar energy is different from that of the standard electric refrigerator The insulation is thicker there is no fan cooling and only sizes with a maximum of 50 units are consistent with the needs of the smaller hospitals or health centres The energy requirements are also low In order to conserve the cold the equipment is designed as chest type top opening door and there is no internal light in the cabinet The equipment shall have the same temperature monitoring devices as for the standard electric refrigerator Solar refrigerators and ice pack freezers use CFC free refrigerant gas and may also have an ice pack freezer Recommended power consumption is less than 0 7 Kwh 24 hours for appliances with a gross volume of less than 50 litres and less than 0
51. OCUREMENT OF EQUIPMENT AND ACCESSORIES E MODEL NO BB 710 E CODE BR 03 2A E COMPANY NAME AND ADDRESS Huurre Group Oy 0 Box 127 33101 Tampere Finland Tel 4 358 20 55 55 11 Fax 4 358 20 55 55 288 E mail exportGhuurre com www huurre com 18 LLLI E FEATURES Type of internal lining of the cabinet Stainless steel Description of shelves and drawers 5 stainless steel drawers Doors Solid outer door plus perspex inner door Lockable Internal air cooling mechanism Fan air cooling Automatic defrosting Internal lighting Interior light 2 x 36 W Temperature indicator and alarm system Digital display to 1 C Mains power failure alarm High low temperature audible and visual alarms Battery back up Thermographs See accessories Interface for Remote Temperature Monitoring Yes E SPECIFICATIONS Internal capacity litres 455 Maximum no of blood or plasma packs loaded 90 x 450 ml blood bags External dimensions in cm H x W x L 205 x 85 x 70 Gross volume litres 580 Weight kg 195 kg E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 2 8 3 1 Internal temperature maximum 5 7 5 2 C Hold over time 35 min 45 38min Cool down time 13 4 hrs Energy consumption 10 2 Kwh 24h E ENERGY REQUIREMENTS Rated voltage frequency 230 V 50 Hz Energy source AC Electricity Min compressor starting voltage at 32 C
52. RF 1 Purpose of Equipment A refrigerator for storing whole blood or red cell packs in a blood bank Type of Equipment Compression type refrigerator that uses CFC free refrigerant gas and electricity supply from the national grid Laboratory Test Procedure Standard Test Procedure BTS Proc 3 Construction Internal Stainless steel min 22g External Corrosion Resistant CR at least 1mm thickness CFC free insulation Drawers Roll out type Door Glass or solid door Electrical Characteristics Input voltage 220 240V 50Hz or 110V 60Hz single phase Equipment meets electrical safety specifications such as that of IEC Minimum Compressor Starting Voltage 22 below nominal voltage Internal Temperature Control Electronic temperature control range 2 C to 6 C with setting accuracy of 1 C whatever the load Fan air cooling External Ambient Temperature Performs in an ambient temperature of 10 to 43 C Hold Over Time A full load of blood packs at 4 C 1 C takes at least 30 minutes to rise to above 6 C Cooling Down Time A full load of blood packs at 25 C takes a maximum of 13 hrs for all the packs to reach below 6 C Temperature Monitoring Digital temperature LED display with 0 1 C graduation Temperature recording device Visual and audible alarm system indicating unsafe temperatures Battery back up for alarm and temperature recording device Facility for remote alarm contact T
53. T OF EQUIPMENT AND ACCESSORIES Back up systems Well trained personnel Standard Operating Procedures that guide the user on how to perform each of the activities involved in storing transporting and packing blood products Measurements that will help to monitor and maintain our control processes CHAPTER 2 THE BLOOD COLD CHAIN PROCESS These elements form the basis of three main working processes storage transportation and maintenance of the blood cold chain Yet it is a very fragile chain one weak link can have very serious even fatal consequences for a patient The national blood cold chain must therefore involve all levels of the health care system from the small district hospital up to the Ministry of Health blood bank refrigerators CHAPTER 3 3 1 Overview The blood storage refrigerator is the basic requirement for any blood bank Unlike domestic types of refriger ators blood bank refrigerators have the following key design features Heavier insulation all round to enable a longer hold over time in the event of power failure and ability to maintain temperatures between 2 and 6 C A cooling fan to enable even distribution of air in the cabinet Temperature monitoring devices comprising an external temperature display facility and an alarm system for abnormal temperature or power failure etc Scratch resistant internal lining of the cabinet stainless steel or aluminium Glas
54. a temperature monitoring device notably alarm systems that can tell whether the temperature is outside the maximum or minimum range Furthermore in order to comply with quality standards a continuous record of the temperature of the contents of the equipment should be kept The existence and performance of these devices are critical during the evaluation of the equipment vi WHO minimum performance specifications In addition to the above information it is important to identify the internationally approved standard with which the equipment complies e g ISO DIN EN or IEC Field evaluation The field evaluation studies on the blood cold chain equipment highlighted the following gaps in the blood cold chain i Lack of skills in preventive maintenance ii Limited knowledge by personnel responsible for blood programmes regarding the management of the blood cold chain iii Numerous pieces of equipment lying idle because of the shortage of spare parts or lack of skills to repair them iv The need for WHO minimum specifications for blood cold chain equipment such as platelet agitators plasma thawing equipment etc v The critical need for an indicator that shows the safe storage history of an individual blood component in all situations Pilot study A pilot study on the status of the national blood cold chain was conducted in 27 countries in May 2001 Although this was a limited and qualitative study it revealed ot
55. al air cooling mechanism Forced air Internal lighting No Temperature indicator and alarm system Yes Thermographs Yes Interface for Remote Temperature Monitoring RS 485 E SPECIFICATIONS Internal capacity litres 167 Maximum no of plasma packs loaded 90 x 300 ml External dimensions in cm H x W x L 131 x 85 x 79 Gross volume litres 246 Weight kg 149 The hold over time and cool down times were measured at 43 C ambient at full load This means that the lower the ambient temperature the better the performance of the equipment CHAPTER 4 PLASMA FREEZERS E PERFORMANCE DATA Full Quarter Empty load load Internal temperature minimum 36 9 35 1 C Internal temperature maximum 36 1 33 5 Hold over time 6 6 4 2 Cool down time 36 5 hrs 18 4 hrs Energy consumption 18 52 Kwh 24h Noise level 64 dBA E ENERGY REQUIREMENTS Rated voltage frequency 240V 50Hz 115V 60 Hz Energy source AC Electricity Minimum compressor starting voltage at 32 C ambient temperature 175 V Minimum compressor starting voltage at 32 C operating temperature 175 V B ADDITIONAL INFORMATION International standards equipment complies with 73 23 EEC 93 68 EEC E RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Compressor 296 9701 11 1 Motorfan 296 9759 02 1 Drier 296 0945 03 1 Gasket door 294 5117 03 1 Door switch 296 9821 01 1 Sensor 296 9804 1
56. all be capable of withstanding a minimum of 1000 cycles to 50 discharge Main tenance intervals shall be limited to a maximum of once every six months No dry cell batteries shall be used to power instruments or controls The batteries shall be housed within a lockable ventilated cabinet with access for maintenance inspection in place Batteries must meet the WHO design specifications Supporting documentation on the batteries must be provided Batteries must be supplied dry charged with acid in separate hermetic containers 4 Battery charge regulator Battery charge regulators must meet WHO design specifications and supporting documentation must be provided They must be precisely set to meet the charge and temperature requirements of the selected battery and disconnect the load when the battery has reached a state of charge that can be repeated for a minimum of 1000 cycles Lightning surge protection shall be provided The load shall be auto matically reconnected when the system voltage recovers Solar technology is reliable However a study of solar powered equipment for vaccine storage conducted by WHO and UNICEF shows among other things that the maintenance and replacement of parts such as batteries and regulators which become necessary after an average of five years remains the major problem because these systems are often located in isolated areas and funds are rarely put aside for this purpose Essential spare parts The
57. and alarm system Digital display alarm functions Thermographs No Interface for Remote Temperature Monitoring No SPECIFICATIONS Gross internal volume litres Refrigerator 76 Freezer 17 Maximum no of packs loaded 38 x 450 ml blood bags External dimensions in cm H x W x L 85 x 94 x 69 Rated voltage frequency 220 240 V 50 60 Hz Weight kg 92 kg E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 3 2 C 38 Internal temperature maximum 4 8 50 Hold over time 10 1hrs 9 4hrs 7 8 hrs Cool down time 16 1 hrs 7 5 hrs Energy consumption Kwh 24 hrs 2 92 2 89 E ENERGY REQUIREMENTS Energy source AC Electricity Minimum compressor starting voltage at 32 C ambient temperature 136 V Minimum compressor starting voltage at operating temperature 132 V E ADDITIONAL INFORMATION International standards equipment complies with DIN EN 9001 1994 Shipping volume gross weight 1 1m 86 kg E SPARE PARTS NEEDED PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Starting device 291 2087 05 3 Capacitor for compressor 291 2146 00 3 Thermostat internal 291 3066 00 1 Compressor 210 0271 00 1 Internal fan 291 3067 11 3 19 Plasma freezers CHAPTER 4 DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT All freezers described in this Guide are compression type freezers WHO has evaluated compression type plasma freezers using CFC
58. ation Reference BTS RF 2 Purpose of Equipment A refrigerator for the storage of whole blood red cell packs for use in blood banks with a limited electricity supply Type of Equipment Compression refrigerator that uses CFC free gas and at least 8 hrs day of electricity The refrigerator compartment is lined with ice containers or has a freezer section with ice packs to enhance the temperature holding capacity of the refrigerator compartment during power failure Laboratory Test Procedure Standard Test Procedure BTS Proc 4 Construction Internal Stainless steel min 22kg External Corrosion Resistant CR at least 1mm thickness Chest type with CFC free insulation Upright trays Solid door Electrical Characteristics Input voltage 220 240V 50Hz or 110V 60Hz AC single phase Equipment meets electrical safety specifications such as that of IEC Minimum Compressor Starting Voltage 22 below nominal voltage Internal Temperature Control Electronic temperature control range 2 C to 6 C in refrigerator section with setting accuracy of 1 C whatever the load In freezer section temperature range 20 C to 40 C Fan air cooling External Ambient Temperature Performs in an ambient temperature of 10 C to 43 Hold Over Time A full load of blood packs at 4 C 1 takes at least 1 hr to rise to above 6 C A full load of blood packs at 4 C 1 C takes at least 2 hrs to rise to above 10 C Cooling
59. ax of 150 min on half load External ambient temperature The equipment must be certified to perform in an ambient temperature up to 43 C Door Safety system 5 Digital temperature display Controlled 7 day temperature recorder Audio visual alarm to indicate safe unsafe temperature Pre set alarm points of 1 5 C and 5 5 C Battery back up for alarm c C d Heated glass or solid door with lock Electrical characteristics a Input voltage 220 240V 10 50HZ AC single phase without transformer b Wired in plug Consumables Four years consumables should be included and detailed in the offer service and maintenance Warranty installation after sales At least 1 year Spare parts Recommended list of spare parts and prices Item 2 plasma freezer Specifications As above except that the operating temperature should be 35 C with a pre set alarm point of 25 C Quotations will be valid only if these conditions are fulfilled CHAPTER 11 SELECTING AND PROCURING BLOOD COLD CHAIN EQUIPMENT 51 Figure 5 Selection of appropriate blood cold chain equipment according to the energy source Adapted from the WHO EPI Product Information Sheets 2000 Facility on YES Rare and short YES Use standard national grid power failure electric equipment i NO Use ice lined No compr
60. by different altitudes There is a formula for correcting the performance rating of the generator according to the altitude of where it will be located formula 196 of its capacity for every 100 m above sea level 196 for every 5 5 above 20 C This is referred to as de rating of the generator It is necessary to do this to ensure the correct size of the generator purchased Door opening test to assess the effect of continual opening of the door of the refrigerator or freezer on the stable running temperature viii Down time the time between breakdown of a machine and its repair Electrical safety rating to assess against internationally accepted standards the safety of the equipment when exposed to electrical shock Energy consumption unlsess otherwise stated this is measured at full load Hold over time the length of time that the equipment can maintain the temperature of blood or plasma within acceptable limits see WHO minimum perfor mance specifications when the energy supply for the equipment is interrupted for whatever reason e g through a power failure Incoterms the International Chamber of Commerce official rules for the interpretation of delivery terms Plasma pack puncturing test to assess the effective ness of transport boxes to prevent plasma packs being punctured during a simulated rough ride Stable running temperature the stability of the temperature of the equipment within set limits and
61. cabinet temperature is outside of the expected temperature range The devices can also warn of a power failure affecting the equipment being monitored WHO has evaluated temperature monitoring devices on cold Temperature monitoring chain equipment for their stability under high voltage fluctuations from the mains supply 8 3 Portable digital thermometers Portable digital thermometers are also available for use in place of maximum minimum thermometers or ordinary thermometers These are often used to provide a back up control of the temperature monitoring devices of the equipment BCT has not evaluated these portable digital thermometers as they have already been extensively evaluated by WHO V amp B Other versions of portable digital thermometers are able to display and record temperature information However to download the information the thermometer needs to be linked to a computer with appropriate MS Windows supported software 8 4 Temperature data loggers Temperature data loggers are now available for use in place ofthe traditional temperature recorder charts They require the use of a computer with appropriate MS Windows supported manufacturer s software to download the information The software enables the start and completion of the temperature recording to be programmed onto the data logger The device is then placed in the cabinet of the blood storage equipment At a pre programmed time the device is retrieved and hooked
62. carefully assessed so that it meets the needs of the laboratory and the users Assess the performance history of the equipment and market reports before making a decision Domestic refrigerators are NOT suitable for the storage of blood e The need for a degree of standardization should be taken into account when procuring equipment as it assists in staff training and equipment maintenance e The equipment should be ordered following agreed procedures e The availability of back up support spare parts and maintenance services are important considerations in the selection of cold chain equipment e Training for users and technicians must be taken into consideration before selecting any blood cold chain equipment 4 Does it meet your current needs 5 Does it have the correct capacity 6 Is the power rating appropriate for the local energy source 7 Is the equipment affordable including its main tenance costs 8 Is the equipment user friendly and suitable for the personnel 9 Are spare parts readily available 10 Are local service contracts available In addition Programme Managers should ensure that cold chain equipment is free of chlorofluorocarbons CFC free Annex 2 provides a user friendly summary of the recommendations outlined in the Montreal Protocol on CFCs as related to the blood cold chain 11 4 Donated equipment Donated equipment should follow the WHO Guidelines on the Donation of Equip
63. ctions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO vi vii viii ix ON 10 10 10 11 11 15 15 16 16 17 17 18 18 20 20 20 21 23 23 23 24 Chapter 6 Plasma Thawing Equipment Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 7 Blood Transport Boxes and Coolants Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 8 Temperature monitoring devices 8 1 Overview 8 2 Electronic versions of temperature monitoring devices 8 3 Portable digital thermometers 8 4 Temperature data loggers 8 5 Blood time temperature indicators Product information on equipment evaluated by WHO Chapter 9 Accessories to the blood cold chain equipment 9 1 Voltage regulators 9 2 Standby generators 9 3 Blood and plasma trays or pack holders Product information on equipment evaluated by WHO Chapter 10 Equipment maintenance 10 1 Preventive maintenance 10 2 Management of repairs 10 3 Procuring essential spares for repairs and preventive maintenance 10 4 Common problems in managing an inventory of spare parts Chapter 11 Selecting and procuring blood cold chain equipment 11 1 Selecting manufacturers 11 2 Pre
64. d maintained by all personnel involved Cold chain equipment must be reviewed carefully bearing in mind the possibility of relocation of some equipment to meet needs The design and quality of equipment should be carefully assessed so that it meets the needs of the laboratory and the users Assess the performance history of the equipment and market reports before making a decision Domestic refrigerators are NOT suitable for the storage of blood The need for a degree of standardization should be taken into account when procuring equipment as it assists in staff training and equipment maintenance The equipment should be ordered following agreed procedures The availability of back up support spare parts and maintenance services are important considerations in the selection of cold chain equipment Training for users and technicians must be taken into consideration before selecting any blood cold chain equipment ISBN 92 4 154579 8 Department of Blood Safety and Clinical Technology World Health Organization 1211 Geneva 27 Switzerland Fax 41 22 791 4836 E mail bct who int e www who int bct S eg az41 bari
65. dard Test Procedure BTS PT 1 Proc 1 Construction Internal Corrosion resistant material easy to clean and no staining External Corrosion Resistant CR at least 1mm thickness Design Chest type lid optional Easy loading and removal of plasma packs Easy to empty water when required Electrical Characteristics Nominal input voltage 220 240V 50Hz or 110V 60 7 AC single phase Equipment meets internationally accepted electrical safety specifications such as that of IEC Internal Temperature Control Tamper resistant temperature control set at 37 C 1 C External Ambient Temperature Performs in an ambient temperature of 10 C to 30 C 5 C Thawing Time A full load of flat plasma packs approx 250ml volume with a core temperature of 30 C 1 C is thawed completely in less than 20 mins Warning Systems Digital temperature LED display with 0 1 C graduation Visual and audible alarm system indicating temperature outside range Audio visual alarm if water level drops Audio visual alarm if plasma pack leaks during thawing if pack is not in a leak proof container PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO PLASMA THAWERS MODEL NO CYTOTHERM DR E CODE PT 01 E COMPANY NAME AND ADDRESS PhotoTherm 110 Sewell Avenue Trenton NJ 08610 USA Tel 1 609 396 1456 Fax 1 609 396 9395 E mail serve phototherm com www cytotherm com E FEATURES Materials Bath is white polypropelyne
66. ded and quality temperature charts to be printed The PC can continue in normal use without affecting the temperature recording 8 5 Blood Time Temperature Indicators BTTI A donated blood pack passes through many stages during processing to make blood components The blood component is exposed to various temperatures for unknown periods during this process and also when the product leaves the blood bank for transfusion to the patient While quality monitoring of equipment and standard The BTTI is Operating procedures for the new device to handling of blood reduce the risk monitor the of exposure to unsafe tem peratures there remains an temperature of a consignment of blood during transportation undefined risk that a unit exposed cumulatively or at once to a higher temperature is returned to available stock in a refrigerator The BTTI has been developed by WHO in consultation with manufacturers in order to have a reliable device to monitor the temperature of a consignment of blood during transportation How it works Based upon the migration of a chemical through a paper wick the BTTI is an indicator on a card that upon activation shows colour changes when the cumulative temperature of exposure exceeds 10 C The BTTI has four windows labelled 1 to 4 that will turn blue upon undue thermal exposure as follows The first three windows will monitor whether the blood has been exposed cumulatively to a temperature
67. dent on the availability of cooler boxes able to maintain temperature over long distances and in relatively high ambient temperatures Blood is often wasted through the use of domestic type picnic cooler boxes or other containers that cannot be relied upon to maintain temperature correctly The absence of safe blood transport boxes therefore affects the movement of blood and compromises management of the national blood inventory The conventional thermometer remains the item in most common A cost effective blood cold chain programme can only be achieved if technologically appropriate equipment for the storage of blood components is The use of thermographs and affordable an accessible at al levels of the health care system use for monitoring the temp erature of blood in storage equip ment in developing countries This is not adequate as the monitoring of the temperature depends on the user who cannot monitor the blood constantly especially outside working hours and may forget audiovisual alarm systems are un common especially with domestic type equipment It is generally accepted that approximately 2 of blood that has been found safe to transfuse may be discarded The use of suitable equipment and good management of the blood cold chain are important means of minimizing losses of donated blood The wider availability and correct use of affordable equipment that meets defined specifications and
68. dle large apheresis type plasma packs and the random donor pack These units are usually bench top designed 2 What type of plasma thawer do you want dry or wet type In the wet type the plasma bags require the use of over wrap plastic packs in order to avoid exposing the plasma to water CHAPTER 11 SELECTING AND PROCURING BLOOD COLD CHAIN EQUIPMENT 3 Is it a random access or batch thawing process equipment i e is the thawing of each plasma pack monitored separately or only as a batch 4 How long does it take to thaw a plasma pack or a batch of plasma packs 5 Reliability Are repair facilities and spare parts available for the plasma thawer to be purchased 6 Temperature monitoring Do you have a fixed temperature display and alarm system 7 Price Which plasma thawer meets requirements 1 6 at the lowest cost 8 Do you need user and service manuals in the official language of your country 9 Training Are the users and those in charge of maintenance of the equipment properly trained 11 8 Purchasing equipment Standardized purchasing of cold chain equipment The standardized purchasing of equipment means purchasing different or similar models from one manufacturer rather than a variety of models from several manufacturers The advantages of the standard ization of equipment are that training staff in the use of the equipment will logistically be easier the maintenance and procurement of s
69. e The quantity of platelet concen trates that may be handled by any given agitator will vary according to whether these are apheresis or random donor harvested platelets Apheresis derived platelet concen trates are usually up to six times heavier than random single donor platelet concentrate packs A motion failure alarm is critical for monitoring the agitator and in the case of an incubator there is need for a temperature monitoring device similar to those in conventional blood storage refrigerators visual and audible alarm systems indicating power failure or temperatures outside the range and seven day chart records See page 55 for detailed checklist on selecting a platelet agitator Key features The design of the door enables the user to inspect the contents without opening the door This minimizes temperature changes in the incubator housing the platelet agitator It is also important for the shelves to be corrosion resistant because of occasional spillage from the pilot tubes of the platelet packs WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Platelet agitators Specification Reference BTS PAC IN 1 Purpose of Equipment To continuously agitate platelet concentrates in an incubator in an even suspension in a plasma bag Type of Equipment Flatbed agitator fitted inside a temperature controlled incubator operating with CFC free refrigerant gas and insulation material and electricity from the national grid Lab
70. elet Agitator Qu UO oO MoO OO oO Walk in Cold room MO OO d MO OO O Walk in Freezer room Mo OO Oo OOo OO oO HMO OO Oo HMO OO O Others MoO OO oO HW oO OO oO MO OO oO 1b Projected need for the following equipment in the next 12 months Plasma 22 2 TIS S Plasma Blood bank refrigerators Platelet agitators Solar Temperature monitoring devices ice lined _ Chart recorders sss standard electric Portable digital thermometers Walk in plasma freezer room Walk in blood refrigerator room ulcer RE 51 2 Volume of blood components handled per month Whole blood Packed cells Plasma eiie Platelet concentrates Other State cotes 3 Transport of Blood Components Yes No 3 1 Does the institution collect blood through mobile donor clinic O How many teams involved Volume handled per month 3 2 Does the institute distribute blood to other hospitals How many institutions Volume handled per mont
71. ements Measurements Identification of measurements and indicators to help keep our process working What data will help keep this well process working well Daily temperature control No of discarded units because of unsuitable storage conditions Table 2 Packing and transport conditions for blood and blood components Process components Example Input What goes in Information Type and quantity of blood components to pack length of travel Materials Blood components ice ice packs wrapping materials coolant pouches Elements Methods Standard Operating Procedures for What makes the e Packing transport of red blood cells process work Packing transport of platelets e Packing transport of plasma and cryoprecipitate Reception of blood products in the hospital Transportation of blood blood components within hospital Reception of unprocessed blood from blood mobiles e Release of blood and blood components Equipment Transport boxes ice machine time temperature indicators Personnel Identify who is responsible for packing and transport blood bank technicians nurses drivers etc Environment Clean open spaces and bench space Measurements Indicators for process control What data will help keep this Temperature at time of reception process working well e Returned products unsuitable transport conditions Periodic quality control of transported products e g Platelet pH CHAPTER 2
72. ent This can be achieved by addressing the two key components of equipment maintenance i e Preventive maintenance and the Management of repairs Both components should be part of the quality management system of the blood bank necessitating a clear policy statement on the maintenance of equipment in general and supported by Standard Operating Procedures 10 1 Preventive maintenance Preventive maintenance has the following specific objectives To reduce the frequency of down time of the equip ment To increase its useful life To ensure its safety To reduce its operating costs To determine its weak points To reduce the cost of repairs Standard Operating Procedures must be developed taking into account the manufacturer s recommended preventive maintenance programme Key to the success of preventive maintenance is compliance by all concerned especially in the area of record keeping Preventive maintenance is reported to extend the life of equipment by 1 5 to 2 times as well as saving around 30 on repair bills 10 2 Management of repairs Equipment repairs are necessitated by failure of components of the equipment and often misuse of the equipment by the user A coordinated programme is needed to ensure that equipment is repaired in a timely and proper fashion and in turn the effectiveness of such a programme will depend on the availability and accessibility of skills tools and spare part
73. es out preventive maintenance Technical staff of the blood bank Q of other State ies cera soe Re Dons 5 2 Are spare parts for blood cold chain equipment kept on site or centrally controlled Locally available J Centrally coordinated 5 3 Common problems experienced in the last 12 months NB Please state as an approximate percentage of all faults reported in the same period Fault Cost of repairs 1 Compressorfaut VN or 2 Refrigerant gas leakage y Nn 3 Corrosion of equipment 4 Faulty internal circulation fan 5 Defective door sealer lining c Ent 6 Faulty temperature monitors EN 7 Faulty switches aa 8 Icebuiltup ae v NN 9 Faulty thermostat 10 Others please state Mr TIE av nr 58 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES The use of chlorofluorocarbons CFC in Blood Cold Chain equipment Environmental and human health concerns about the depletion of the ozone layer in the earth s atmosphere have led to a global effort to phase out the production and consumption of CFCs Until 1995 two major CFCs R11 and R12 were commonly used as refrigerants in compression refriger ation circuits and as foaming agents for the insulation of refrigerators freezers and insulated container
74. ession equipment Enough sunshine for solar powered More than refrigeration YES 4 5kw m2 day inthe YES Use solar powered Advice of worst month of compression equipment meteorological office the year required NO NO Not feasible to store blood at location adequate ventilation to reduce stress on the give a guide on the capacity of the different storage equipment However because of the possibilities of breakdown and the fact that blood should not be stored outside acceptable temperature ranges for more compressor unit of the cold chain equipment An alternative power source for use in the event of the failure of the normal electricity supply e g a than 30 to 60 minutes alternative cold chain standby generator equipment should be available and have adequate capacity to accommodate products from another unit 11 5 Quantity in an emergency The number of units to be bought will depend on the findings of the needs assessment and estimate of future requirements The major points to note are as follows The quantity of units required directly relates to the capacity of the equipment Tables 6 7 and 8 below it is important to allow for growth in the number and activities of blood transfusion services and hospital blood banks The quantity and capacity of equipment to be purchased must therefore take possible needs for up to 5 years into account Table 6 Classification of blood refrigerator
75. estic freezers is not recom mended because the operating temperature of a domestic freezer does not fall below 20 C cooling down time for a load of plasma is too long See page 54 for a detailed checklist on selecting a plasma freezer 20 they are usually poorly insulated especially the doors and are not designed to maintain the temperatures recommended they warm up quickly when electricity fails they may not operate in high ambient temperatures 43 C temperature monitoring devices are not routinely fitted In summary the storage time for plasma stored in domestic freezers is shorter than in plasma freezers and the quality may be compromised WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Plasma freezers Specification Reference BTS FR 1 Purpose of Equipment To freeze and store plasma in a blood bank Type of Equipment Compression freezer with CFC free refrigerant gas and electricity supply from the national grid Laboratory Test Procedure Standard Test Procedure BTS Proc 1 Construction Internal Stainless steel min 22g External Corrosion Resistant CR at least 1mm thickness CFC free insulation Design Chest or Upright Type Door Solid door Drawers Roll out type Electrical Characteristics Input voltage 220 240V 50HZ or 110V 60HZ AC single phase Equipment meets electrical safety specifications such as that of IEC Minimim Compressor Starting Voltage 22 below nominal volta
76. free refrigerant gas and electricity supply from the national grid A plasma freezer need not be connected to a standby electricity generator because the freezer normally holds temperature below freezing point for more than 24 hrs unless the door is opened frequently The freezer is especially designed for the storage of plasma It has an internal fan cooling mechanism to ensure the distribution of air The freezer ig evenly throughout the equipment especially designed to store plasma t devices Ideally after opening the has an internal fan cooling mechanism to ensure the distribution of air evenly throughout the equipment and temperature monitoring devices and temperature monitoring door each shelf may be opened separately thus conserving the temperature The insulation of the equipment is thicker than an ordinary domestic freezer and this helps to maintain temperature lower than 35 C The key limitations for optimal performance are the cooling or freezing down time Plasma is generally loaded in a freezer while at room temperature The bigger the volume loaded the longer it will take to cool the plasma to the acceptable temperature of storage of below 35 C The user may opt to reduce the load in order to achieve safe storage temperatures more quickly This means more storage space is required for a given load of plasma prepared While the local domestic freezer is readily available storage of plasma in dom
77. g water may seriously affect the readability of the labels on the plasma packs The bath can be cleaned and fresh water put in as necessary Key features Plasma thawers should be able to thaw all types of plasma packs either folded or flat in form and apheresis packs In some designs it may be necessary to protect the ports on the pack by overwrapping to prevent water leaking through the port into the bag Modern plasma thawers ensure that the operator does not get his hands wet Bench top or floor standing models are available Important features are the water drainage facility alarm systems and the speed of thawing Alarm systems The plasma thawer may have an alarm to warn the user of low water levels in the bath The alarm for high temperature should also be fitted to ensure that the plasma packs are thawed at 37 C In some models using open systems the plasma pack may leak on thawing See page 55 for a detailed checklist on selecting plasma thawing equipment 26 plasma packs are generally brittle An alarm system to detect plasma leakage is fitted in such equipment WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Plasma thawers Specification Reference BTS PT IN 1 Purpose of Equipment To thaw rapidly frozen plasma Type of Equipment At 37 C water bath Plasma packs held in special containers and constantly agitated uniformly in the bath until thawing is complete Packs remain dry Laboratory Test Procedure Stan
78. ge Internal Temperature Control Electronic temperature control Operating temperature 35 C to 40 C with setting accuracy of 1 C whatever the load Fan air cooling Automatic defrost within safe temperature range External Ambient Temperature Performs in an ambient temperature of 10 to 43 C Hold Over Time A full load of plasma packs at 36 C takes at least 1 hr to rise to above 20 C A full load of plasma packs at 36 C takes at least 32 hrs to rise to above 5 C Cooling Down Time A full load of plasma packs at 25 C takes a maximum of 5 hrs for all the packs to reach below 5 C A full load of plasma packs at 25 C takes a maximum of 30 hrs for all the packs to reach below 20 C Temperature Monitoring Digital temperature LED display with 0 1 C graduation Temperature recording device Visual and audible alarm system indicating unsafe temperatures Battery back up for alarm and temperature recording device Facility for remote alarm contact PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO PLASMA FREEZERS E MODEL NO 160 991 7901 10 E CODE PF 01 2 E COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic lu E FEATURES Type of internal lining of the cabinet V2A 1 4301 Description of shelves and drawers Grids or drawers Doors Plain door Intern
79. give a full guarantee for part of the equipment for a further period e g a compressor It is important to remember that unless poor quality equipment has been selected the equipment is still fairly new during the period of guarantee and is less likely to break down After the period of guarantee the cost of the maintenance and repair of the equipment falls to the user 56 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES ANNEX 1 Information provided by elf assessment questionnaire on the status of the Blood Cold Chain Name Name of Institution Position District Date Province Region Tel Fax E Mail 1 Blood Cold Chain Equipment Yes No 1 1 Is the procurement of equipment and spares training and maintenance coordinated nationally 1 2 Is there a nationally controlled inventory of blood cold chain equipment 1a Equipment in current use at the institution Please list below by type of equipment available at the Institution You may need more space Type of Model Manufacturer Ser No Internal Maximum Date Temp monitors CFC free Equipment capacity l packs possible first used refrigerant T chart Alam LED Yes No Blood refrigerator Qa uu Oo HMO OO HMO OO oO 2 a OO a HMO e ie oO Plasma freezer MoO ald oO Qa HMO OO O Plat
80. h 3 3 Does the institution have transport boxes in use d No with capacity lt 4 Vo with capacity 5 to 10 Vo with capacity 11 to 20 No with capacity 221 3 4 Time taken to deliver a transport box to another institution arrora bre carts eames hrs Longest hrs 3 5 Temperature monitoring devices used intransportboxes ett ete IHR 3 6 Type of blood transport box in use 1 Picnic camper type of box 2 A locally constructed box Material used itr constr ction KNOWN 52 222 Er Ep De Treo ese net arx ert HE eor Sy dena Dn Fo penne INE RE E E aude 3 If a blood transport box what International Standard s does it conform to _ et neta ee eeeeeen ees 3 7 Type of coolants cooling devices used to keep temperature low 1 Ice packs dq u 2 Commercial coolants 3201615 please state avene atm di EO ers ER CER E 4 Quality management of the Blood Cold Chain Yes No 4 1 Does the institute have a Standard Operating Procedure for preventive maintenance of the equipment J 4 2 Does the Institution have a Standard Operating Procedure for monitoring temperature of the equipment 4 3 Are staff regularly trained according to the SOP in place Q 5 Equipment Maintenance 5 1 Who carri
81. he hold over time and cool down times were measured at 43 C ambient at full load This means that the lower the ambient temperature the better the performance of the equipment CHAPTER 3 BLOOD BANK REFRIGERATORS MODEL NO BR 320 E CODE BR 01 2A COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu m www dometic lu Ss no E FEATURES Type of internal lining of the cabinet Stainless steel Description of shelves and drawers Grids or drawers Doors Plain door or door with glass Internal air cooling mechanism Forced air Internal lighting Yes Temperature indicator and alarm system Yes Thermographs Yes Interface for Remote Temperature Monitoring RS 485 SPECIFICATIONS Internal capacity litres 319 net volume Maximum no of blood or plasma packs loaded 240 pks External dimensions in cm H x W x L 174 x 85 x 79 Gross volume litres 408 Weight kg 179 E PERFORMANCE DATA Full Half Quarter load load load Internal temperature minimum 3 6 3 5 Internal temperature maximum 4 3 4 2 Hold over time 1 3 0 9 0 5 Cool down time 11 7 2 7 Energy consumption 3 76 3 34 Kwh 24h not tested E ENERGY REQUIREMENTS Energy source Rated voltage frequency 220 240 V 50 Hz and 115 V 60Hz Int standards EMI 89 336EEC Low
82. he informal tender is that there may be a relatively limited range of equipment from which to choose It is advisable for organizations to purchase equipment exclusively through formal or informal tendering procedures Figure 4 gives an example of a specification for tendering which may be useful as a guide 11 3 Factors to consider in selecting blood cold chain equipment A Needs Assessment questionnaire has been prepared to assist national authorities and organizations using blood cold chain equipment to determine the effectiveness of the blood cold chain equipment and supplies see Annex 1 The selection of cold chain equipment will depend on three primary issues the equipment required to meet current needs the equipment required to meet future needs the equipment available on the market The key questions to consider in selecting cold chain equipment are 1 Does the equipment conform to WHO minimum performance specifications 2 Isitappropriate for the environment 3 Is it guaranteed to perform to international standards 49 Some key factors to consider Blood cold chain equipment must meet international standards WHO minimum performance specifications and be correctly used and maintained by all personnel involved Cold chain equipment must be reviewed carefully bearing in mind the possibility of relocation of some equipment to meet needs e The design and quality of equipment should be
83. her dimensions to the blood cold chain notably i In the majority of developing countries the blood cold chain is not nationally coordinated and this has a negative impact on the organization of the preventive maintenance and repair of blood cold chain equipment ii Temperature monitoring devices are not routinely used in the domestic equipment still in regular use in the blood banks nor in domestic picnic type of boxes used for blood transportation iii Information on the recommendation that all cold chain equipment should use CFC free refrigerant gas by 2005 is not widely known iv There is a need for information materials on the management and use of equipment minimum performance specifications and reference standards in order for managers to select and procure appropriate equipment for the blood cold chain Outcomes This information continues to shape the Project s activities For example in order to address the problem of preventive maintenance and management of the blood cold chain BCT is developing learning manuals for use by managers and users of blood cold chain equipment See Annex 2 and Montreal Protocol on the use of CFC refrigerants at www unep ch ozone pdf Montreal Protocol2000 pdf One module User Manual for the Blood Cold Chain is in preparation for laboratory technical staff in blood transfusion centres and hospital blood banks who are responsible for the installation monitoring and ro
84. ible tone sounds and the basket rises automatically out of the water for easy unloading Temperature control Temperature is controlled with a microprocessor based PID controller The controller monitors water temperature through an RTD sensor and activates the high capacity heater to maintain constant water bath temperatures E SPECIFICATIONS Capacity in litres DH4 18 DH8 32 DH4 4 250 1000 DH8 8 250 1000 DH4 38 x 47 x 37 DH8 38 x 47 x 56 Max no of plasma packs 450 or 1000ml External dimensions in cm HxWxD Gross volume litres DH4 70 DH8 100 Weight kg without water DH4 26 DH8 34 E PERFORMANCE DATA Full Min load load Thawing time at 37 C 250ml bag frozen flat 10 12 mins 8 10 mins 500ml bag frozen flat 18 20 mins 16 18 mins Water bath temperature 37 C factory setting can be changed by operator Energy consumption DH4 115V 6 0A 230V 3 0A DH8 115V 10 0A 230V 5 0A ACCESSORIES Overwrap bag 1000 400273 1 Digital solar thermometer DTI Chamber cover for DH4 CT4 Chamber cover for DH8 CT8 E ENERGY REQUIREMENTS Rated voltage frequency 110 120V 50 60Hz 220 240V 50 60Hz Energy source AC Electricity E ADDITIONAL INFORMATION International standards equipment complies with EN60601 1 EN61010 Shipping volume gross weight including pallet DH4 0 55 50 kg DH8 0 62m 58 kg Helmer Plasma Thawing Systems have integrated agitation to achieve rapid
85. ilable in local currency Maintenance programmes 2 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES of blood cold chain equipment will also be significantly improved Development of laboratory test procedures For blood refrigerators or plasma freezers the critical performance specifications to be measured were identified as follows i Ability of the equipment to maintain a stable temp erature under extreme ambient temperatures and humidity 10 C to 43 C and 60 humidity The desired temperature range for the storage of blood is 2 C to 6 C with an operational temp erature of 4 C The operational temperature of the plasma freezer is 35 C to 40 C ii The time it takes for the temperature of blood to rise above 6 C when the power supply to the equipment is cut off This is referred to as the hold over time which depends on the quality of the insulation of the cabinet The longer the hold over time the safer the blood will be during power cuts The hold over time is less critical for plasma freezers since plasma frozen at 35 C will take at least 24hrs before it begins to thaw unless the freezer is opened frequently There is considerable variation in the hold over time of equipment between different manufacturers The blood cold chain manager should therefore take into consideration the reliability of the power supply and select equipment with an appropriate hold
86. ing quotations for the equipment delivery date and related conditions Usually a closing date for the submission of bids is given and all bids remain sealed until this date at which time they are opened together in the presence of all bidders if possible A formal tendering procedure is commonly used when high value equipment is to be bought single or multiple The advantages of formal tendering are 1 an increase in transparency of the purchasing process Suppliers consider the process as conducive to fair trading CHAPTER 11 SELECTING AND PROCURING BLOOD COLD CHAIN EQUIPMENT 2 increased value for money Suppliers give their best quotations secretly in order to secure a contract The major disadvantage is that it is a lengthy procedure Informal tendering Informal tendering is a procedure commonly used by an organization when there are few suppliers who are generally known within or outside the country The procedure is also adopted when the value and quantity of the equipment to be acquired is relatively low When the informal tendering procedure is used the specifications and quantities of equipment required are compiled and submitted to known suppliers who are usually given a relatively short time to submit their bids The advantage of informal tendering is that the procedures are more rapid and generally predictable as the equipment available from each supplier is often already known The major disadvantage of t
87. ir of the equipment establishing a system to train all users of blood cold chain equipment 2 Users Users of blood cold chain equipment include blood donor attendants drivers laboratory technical staff and clinical staff whose main responsibilities include Donor Clinic Staff who are in charge of blood collec tion sessions with a specific role to ensure safe blood collection and delivery to the hospital blood bank Safe blood collection includes Safe storage of donated blood during blood collection sessions and Safe transport of donated blood 6 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Table 1 Storage of blood components Process components Example Input What goes in Information Collection and expiry dates to identify useable products Materials Blood Components Elements Methods Standard Operating Procedures on how to store each component What makes the e Whole blood red cells process work e Plasma products e Platelets Equipment Specific equipment to store and monitor the different blood components refrigerators freezers platelet incubators backup generator cold boxes thermometers temperature recorders etc Personnel Identification of who will be in charge of storing and monitoring managers technicians nurses Environment Blood and blood products need clean and temperature controlled space Cold chain equipment has space requir
88. is appropriate for the environment in which it will be located will enable an effective blood cold chain to be established and make a significant contribution to blood safety The WHO Blood Cold Chain Project is meeting this challenge by providing technical information based on the testing of equipment that will empower those responsible for health care programmes to manage the blood cold chain A cost effective blood cold chain programme can only be achieved if technologically appropriate equipment for the storage of blood components is affordable and accessible at all levels of the health care system The equipment must meet international standards together with WHO minimum performance specifications and be correctly used and maintained by all personnel involved 1 2 Objectives of the WHO Blood Cold Chain Project The objectives of the WHO Blood Cold Chain Project are To determine minimum performance specifications of equipment and devices that are identified as essential to the blood cold chain in developing countries To publish information on the maintenance of blood cold chain equipment and devices To facilitate technology transfer to developing countries To develop learning materials on the management of the blood cold chain and promote their use by managers and users of equipment To develop new technologies to address the needs of developing countries BCT invited a range of manufacturers of vital blood
89. it E ADDITIONAL INFORMATION International standards equipment complies with CE UL 2601 1 CSA C22 2 No 601 1 FDA BK960012 Shipping volume gross weight 0 153m 17 kg E SPARE PARTS FOR 10 UNITS ALL ACCESSORIES INCLUDED WITH UNIT Magnetic pump Board Heater MODEL CYTOTHERM 4T TURBO E CODE PT 03 COMPANY NAME AND ADDRESS PhotoTherm 110 Sewell Avenue Trenton NJ 08610 USA Tel 1 609 396 1456 Fax 1 609 396 9395 E mail serve phototherm com www cytotherm com E FEATURES Materials White polypropelyne internal and external Temperature indicator Large digital thermometer Alarm systems Over temperature alarm and turn off when temperature reaches 38 C independent thermostat that turns off heaters at 42 C low water level alarm and heating turn off Senses plasma leaks Loading plasma packs Plasma packs are loaded and unloaded with dry hands and gloves Ports are kept sterile out of the water Rocking turbo agitation Will thaw 12 plasma bags with accessory 6 bag corral Temperature control Digital SPECIFICATIONS Capacity in the bath in litres 12 Max no of plasma packs 12 x 450ml External dimensions in cm H x W x L 33 x 56 x 56 Gross volume litres 103 Weight kg 9 E PERFORMANCE DATA Full Min load load Thawing Time 300ml bag of 14mins 12 mins 250ml plasma 12 bags 6 bags Water bath temperature 37 C Noise level Low Free video and
90. lly requested by suppliers from outside the country and is referred to as an Irrevocable Letter of Credit Organizations of the United Nations system the Red Cross and most nongovern mental organizations NGOs will not accept Letters of Credit For standard equipment 30 days payment terms is the norm 53 11 7 Checklists In addition to the general checklist featured on pages 49 and 50 and the Needs Assessment featured in Annex 1 the following checklists summarize the most important elements to consider in selecting blood cold chain equipment Checklist for selecting a blood bank refrigerator or a plasma freezer 1 10 11 54 Storage capacity How many units of blood or plasma must be stored per month at 2 6 C at 40 C External temperatures performance of the refriger ator freezer at 32 C or 43 C internal mini mum and maximum temperatures For blood storage select refrigerators that remain in the 2 C to 6 C range For plasma storage select freezers that remain at 35 C or colder Power source Which power sources are available Electricity what voltage 50 or 60Hz Is supply continuous or not Do you need a voltage stabiliser Is it affordable Continuous refrigeration is required for blood storage It is often difficult to ensure this in areas where power sources are intermittent The longer the hold over time of the refrigerator the better the securi
91. load Internal temperature minimum 4 1 C Internal temperature maximum 5 0 C Hold over time 4 5 hrs Cool down time 22 3 hrs Energy consumption 1 14 Kwh 24h E ENERGY REQUIREMENTS Rated voltage frequency 12 or 24 VDC 60Hz Energy source Minimum compressor starting voltage at 32 C ambient temperature Minimum compressor starting voltage at operating temperature E ADDITIONAL INFORMATION International standards equipment complies with code AM1 Shipping volume gross weight 0 73 78 kg E RECOMMENDED SPARE PARTS PER 10 UNITS OF EQUIPMENT Spare part Code Quantity Compressor BF50F 296 9702 08 1 Fan 12 VDC 296 9710 65 1 Fan 230 VAC 296 9759 531 1 Drier 296 0945 02 1 Temperature controller EWPC 901 296 9764 02 1 3 4 Ice lined blood bank refrigerators DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT Ice lined refrigerators are especially designed to have a longer hold over time This means that unlike standard electric blood bank refrigerators they may hold the temperature below 10 C for up to 72 hours following a power cut This is achieved through lining of the cabinet with water ice containers or freezer sections with ice packs positioned adjacent to the blood storage area During periods of power failure and load shedding the ice packs act as a means of cold storage to protect the units of blood stored in the refrigerator Ice lined refrigerators are str
92. ment in preparation Blood cold chain equipment is sometimes supplied by international donor agencies or bilateral aid pro grammes The preparation of the specifications and quantities required should be undertaken in the same way as in normal tendering procedures However the purchasing office of the However great the need for donations of equipment may be it is essential that the equipment meets the defined specifications donor country or inter national agency may undertake the actual organization of the tender In some cases the donor may wish to provide specific blood cold chain equipment However great as the need for donations of equipment may be it is essential to ensure that the equipment to be supplied meets the defined specifications e g power rating and preferred brands Look at the following checklist of questions to help in assessing whether donated equipment will meet your requirements Factors to consider when considering offers of donated equipment In addition to the list of key questions to consider listed under Section 11 3 which are equally valid for donated equipment other issues to consider include 1 Is the transportation included as part of the donation 2 Who will pay the local taxes and customs clearance and 3 Isthere a local representative Countries may have either of the following types of electricity power rating 110v 60 Hz or 220 240 50 Hz Itis essential to ensure
93. nd Crown Agents meets WHO UNICEF Standard E4 CB 4 Shipping volume gross weight 0 09m 10 kg Minimum order 1 ce packs supplied by Thermos do not meet WHO UNICEF standards Cold life with blood calculated on basis of tests described in CRL A 9000 which established difference between performance with vaccine and blood 32 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Small blood cold box short range E MODEL MT12E CF 991 7708 11 E CODE BB 04 3 PIS B4 62M E COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic com E SPECIFICATIONS Blood storage capacity 15 x 450 ml Weight fully loaded 21 kg Weight empty 11 kg External surface material Polyethylene Internal lining material Polyethylene Insulation material Polyurethane foamed with cyclopentane Insulation thickness in cm 9 11 5 External dimensions H x W x L in cm 50 x 55 x 47 Internal dimensions H x W x L in cm 27 x 34 x 26 Blood storage dimensions H x W x Lin cm 19 x 26 x 18 Lid type and fixings Hinged No of ice packs required 12 No of ice packs supplied 12 Ice pack types E5 09 Robustness in drop test Fittings 2 Casing 1 Cold life without openings hrs at 32 C 108 hrs at 43 C Standards complied with Test reports UNIVALLE E4 3010 1998 Meets WHO UNICEF S
94. ng temperature E ADDITIONAL INFORMATION International standards equipment complies with AABB FDA product evaluated by WHO in 2000 under Model No CTF 406 22 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES degree of amplitude Platelet agitators CHAPTER 5 DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT Platelet agitators are designed for the storage of platelets at a temperature of between 20 C 24 C Only standard electric models are available Platelets must be kept agitated if they are to retain their viability and adhesive properties Only the flatbed type of agitator has been evaluated as it is reported that the agitation achieved is better than that obtained in rotary types of agitators The platelet agitator may be fitted inside an incubator which maintains the desired temperature or left as a free standing unit in an air conditioned room set at between 20 24 C There are differing sizes and designs Since the agitation is continuous the equipment has to be robust and emit low noise Key performance factors are the degree of amplitude of the agitation and the number of strokes achieved per minute These two factors measure the extent of the agitation in order to ensure Key performance maximum effect thus allowing free factors are the exchange of gases within and outside the blood pack of the agitation and the number of strokes achieved per minut
95. nger life span and low maintenance costs generally more than justify the investment Costs Information is needed on the market situation i e what products are on offer at what price Note that manu facturers change and update their models regularly which may also affect prices The WHO Procurement Services can be consulted for up to date information and sources for manufacturers contact procurement who int For any purchase over US 15 000 the WHO Procurement Services will automatically seek a minimum of three offers from different sources Issues to consider are the following 1 Thebudgetavailable for capital expenditure on blood cold chain equipment 2 Is the equipment being imported directly by the purchasing organization or through a local import agent 3 Ifitis being directly imported by the organization the following costs should be checked a the Free on Board FOB price FOB is the cost of the item from the manufacturer or his agent without any shipment costs b the Cost Insurance and Freight CIF charges CIF includes the cost of the item freight charges including handling fees and insurance This is sometimes referred to as the landed cost of an item i e the cost to bring it into the country If the equipment is being bought locally or through a local import agency the main consideration is the landed cost to the laboratory c Customs clearance charges unless the institution is exempt from Customs
96. ntenance schedules in order to reduce down time on the equipment It is the responsibility of the users to ensure that reports on the performance of the equipment are submitted to management regularly Figure 2 shows a schematic diagram of the possible structures of a national blood programme It also shows the line of supply of blood i e of a model blood cold chain 2 3 The blood cold chain as a work process A process is a series of activities or events involving people equipment information materials the environ ment measurement and procedures It is the inter connected series of these elements that make it possible for blood components to flow safely from the donor s arm to the patient s arm Quality is inherent in a process it is therefore essential to adopt a quality oriented approach to the management of the blood cold chain The blood cold chain is one of the many working processes within a blood bank People equipment different elements involved will assist in the evaluation of the current status of the blood cold chain and the implementation of any changes that are necessary 2 4 Blood cold chain personnel Personnel involved in the blood cold chain include a managers and b users with the following major responsibilities 1 Managers the selection and procurement of blood cold chain equipment establishing a quality system for the correct instal lation usage monitoring maintenance servicing and repa
97. od bank All facilities or equipment to be connected to the emergency generator need to be correctly included e g cold rooms laboratory equipment water baths incubators for cross matching refrigerators lights Most blood cold chains in developing countries need a standby generator unless the mains Current is very reliable microscopes etc that are essential to deliver the service This information plus data on temperature and altitude are essential if the supplier is to make an accurate estimate of the size of standby generator required To ensure accurate information and avoid a costly waste of limited resources it may be prudent to use a qualified engineer to perform this function especially when a new blood bank is built The generator is de rated as follows 1 of its capacity for every 100 metres above sea level 1 for every 5 5 above 20 C Example Size required 14 KVA determined by measuring starting and running currents Altitude above sea level 500 m de rating 5 Ambient temperature 31 C de rating 2 Total de rating 7 Size of unit to be purchased 15 KVA 14 7x14 100 Most cold chains operate on standby generators only during power cuts If a generator needs to operate continuously on full power rate it at 80 of the indicated output Most manufacturers indicate outputs as continuous normal or standby emergency boost Other points to consider Petrol or diesel Mo
98. of blood and blood components is affordable and accessible at all levels of the health care system We hope you will find this Guide useful and welcome your comments to enhance future editions of this work Dr Jean C Emmanuel Director Blood Safety and Clinical Technology CHAPTER 1 Blood transfusion is an essential part of modern health care Used correctly it can save life and improve health However as with any therapeutic intervention it may result in acute or delayed complications and carries the risk of transmission of infectious agents such as the human immunodeficiency virus HIV hepatitis viruses syphilis and Chagas disease Yet transfusion transmissible infections are only one cause of unsafe blood and blood products Safe and effective transfusion requires the implementation of the following integrated strategy for blood safety The establishment of a well organized nationally co ordinated blood transfusion service with quality systems in all areas The collection of blood only from voluntary non remunerated donors from low risk populations Testing of all donated blood including screening for transfusion transmissible infection blood grouping and compatibility testing Areduction in unnecessary transfusions through the effective clinical use of blood and blood products including the use of simple alternatives to transfusion wherever possible The safe storage and transportation of blood and bl
99. om the time it is National Blood Transfusion Service Alternative System Hospital Based Blood Programme collected up to the time it is transfused Packing and transportation which includes equipment and materials National Blood Transfusion Centre 1 1 VS 1 1 Central Hospital Blood Bank needed to move blood components safely through the blood cold chain Maintenance of equipment which provides the proper management infrastructure and backup needed to ensure a reliable sustainable and safe blood supply lt Occasional supply of blood Y y Regional Provincial Blood Regional Provincial Hospital Transfusion Centre y Blood Bank lt 4 Line of authority N Y T lt Main supply of blood District Hospital Blood Bank Tables 1 3 illustrate the intercon nections within each of the three main activities An understanding of the Annex 1 in order that appropriate equipment and personnel are put in place It is the responsibility of the managers at each level of the blood cold chain to identify the key components from collection to transfusion in a given district province or country Users of cold chain equipment need to be trained according to an agreed national programme in order to ensure uniformity of practice Reporting on the performance of cold chain equipment needs to be standardized as do preventive mai
100. ongly recommended for blood banks located in areas with unreliable power supply and frequent power cuts typically in district or regional 11 centres However to comply with WHO standards ice lined equipment should be fitted with temperature monitoring devices and alarms systems The freezer part of the equipment is not recommended for the storage of plasma packs since the temperature of the freezer section of ice lined equipment does not typically fall below 10 C which is unsuitable for the medium to long term storage of fresh frozen plasma The ice packs may also be used in blood transport boxes In order to freeze the water lining within a limited number of hours when the power is available the compressor has to operate extensively and the storage area in the bottom of the appliance falls below 0 C Blood bags should therefore NOT be stored within 15 cm of the base of these models Another limitation with this type of equipment is that although the chest type design ensures low temperature storage by reducing the loss of cold air during opening access to blood bags at levels below the top shelf requires the entire basket to be removed This is often cumbersome and can quickly increase the temperature of the cabinet Protection of the blood bags also needs to be ensured whilst seeking to attain freezing temperatures for the ice lining WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Ice lined blood bank refrigerators Specific
101. ood products is an integral component of the WHO strategy for blood safety A hiatus in any one of these strategies can compromise the safety of blood This publication focuses on the adequate storage and transportation of blood com ponents and provides specific guidance for health care personnel on the selection procurement and main tenance of related equipment and technology needed from donation to transfusion a process referred to as the blood cold chain 1 1 The global challenge Many factors contribute to the poor storage and trans portation of blood components in developing countries Introduction to the WHO Blood Cold Chain Project Limited resources and lack of access to appropriate technology are two major challenges that threaten blood safety Limited resources discourage some countries from purchasing purpose designed blood bank equipment In countries with restricted economies domestic refrigerators and freezers are often used for the storage of blood and blood components Although generally affordable they are not suitable for blood storage because they are not designed for this purpose The insulation in domestic equipment is poor and in the event of power failure they will not hold temperatures well Furthermore domestic refrigerators do not have temperature monitoring devices such as audiovisual alarms for temperatures outside the set limits for the products being refrigerated Even basic blood time tempera
102. ood is collected and continues until it is transfused The blood collected and screened as safe for transfusion may be moved from a central to Figure 1 WHO definition of blood components Unit of Blood Plasma Whole blood Cells Cellular components a regional blood bank or district hospital depending on the structure of the national blood programme Small or remote hospitals may independently Plasma donor collect and store their own blood However this is often not Plasmapheresis as cost effective as centralized processing testing and distri bution from selected regional centres Blood may sometimes Plasma derivatives e Red Cels 7 7 e Platelets Plasma Immunoglobulins 7 Albumin e Coagulation factors be moved from regional centres to a central hospital which is unable to meet the demand from within the urban population it Direct clinical use Fresh frozen plasma Cryoprecipitate serves Viralinactivated plasma A needs assessment should be undertaken see Chapter 11 and Ministry of Health eS Figure 2 Possible structures of a national blood programme procedures all work together to produce an end result safe and useable blood and blood components There are three main activities involved in the blood cold chain process Storage which keeps blood at the correct temperature fr
103. oratory Test Procedure Standard Test Procedure BTS PAC Proc 1 Construction Internal Stainless steel min 304 grade External Corrosion Resistant at least 1mm thickness Designed to hold a load of random platelet packs 300ml bag size or apheresis platelet packs 500 x 1 litre or a mixture of both types Doors enable inspection of contents without opening the door Design of Shelves Shelves are made of corrosion resistant material with sufficient clearance to minimize noise Easy loading and withdrawal of platelet packs Shelves cannot be pulled out in error The agitator holding the shelves is suspended in such a way as to ensure minimum noise for the life of the agitator Electrical Characteristics Nominal input voltage 220 240V 50Hz or 110V 60Hz Equipment meets electrical safety specifications such as that of the IEC Internal Temperature Control Fan cooling Electronic temperature control to maintain even temperature at 22 C 0 5 C at all shelves 23 External Ambient Temperature Incubator performs in an ambient temperature range of up to 43 C 1 C and Relative Humidity of 60 Monitoring Motion of Agitator A motion failure alarm Temperature Monitoring Digital temperature LED display with 0 1 C graduation Visual and audible alarm system indicating temperature and power failure Door ajar alarm Seven day chart recorder or electronic record of maximum and minimum temperature attained Performance
104. ort boxes required Level Handling capacity Equipment Quantity needed needed for needed Central 3 000 donations per month Cold room 2 9 cu m each Refrigerators 8 80 100 units each Freezers 4 80 100 units each S Freezer rooms 2 6 cu m each Component production Blood transport box BB4 15 BB3 5 BB2 5 BB1 10 Mobile blood collection and distribution to regional centres Regional Provincial 1 000 donations per month Refrigerator 5 80 100 units each Freezers 3 80 100 units each Blood transport boxes BB4 5 BB3 5 BB2 5 BB1 5 Mobile blood collection and distribution to district hospitals District 200 donations per month Refrigerators 3 80 100 units each Freezers 2 80 100 units each Blood transport boxes BB2 2 40 BB1 2 Based on 6 7 units transfused per hospital bed year plus allowance for waste 11 6 Methods of payment The suppliers usually specify the method of payment for equipment during the time of bidding Acceptance of the bid submitted by a supplier generally means acceptance of the conditions of supply by the organization although the specific terms and conditions of supply are normally agreed at the next stage i e the Purchase Order or other contract Some suppliers may require a deposit to be paid or full payment in advance CHAPTER 11 SELECTING AND PROCURING BLOOD COLD CHAIN EQUIPMENT or an irrevocable letter issued by the bank guaranteeing payment The latter is usua
105. ourg Tel 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic com SPECIFICATIONS Blood storage capacity 26 x 450 ml Weight fully loaded 44 kg Weight empty 17 kg External surface material Polyethylene Internal lining material Polyethylene Insulation material Polyurethane foamed with cyclopentane Insulation thickness in cm 10 5 External dimensions H x W x L in cm 71 x 55 x 50 Internal dimensions H x W x L in cm 50 x 34 x 27 Blood storage dimensions HxWxL in 42 x 26 x 19 Lid type and fixings Hinged No of ice packs required 24 No of ice packs supplied 24 Ice pack type E5 09 Robustness in drop test Casing Cold life without openings 141 hrs at 32 C 101 hrs at 43 C Standards complied with WHO GBSI Standard B4 CB 2 Test report GET 50361 3300 WI BO 1995 Shipping volume gross weight 0 29m 48 3 kg Minimum order 1 31 Small blood carrier MODEL 3504 38 CF E CODE BB 02 1 PIS B4 18M COMPANY AND ADDRESS Thermos 2550 W Golf Road Suite 850 Rolling Meadows IL 60008 USA Tel 1 800 243 0745 Fax 1 847 593 5248 SPECIFICATIONS Blood storage capacity 2 units Weight fully loaded 5 1 kg Weight empty 1 8 kg External surface material Polyethylene Internal lining material Polyethylene Insulation material Polyurethane Insulation thickness 40 mm External dimensions H x W x L in cm 24 x 24 x 33 Internal dimension
106. ow the box will be transported by vehicle bicycle or hand carried and how roughly it will be treated For example durability will be more important than weight for a box transported by vehicle over rough roads so it should have a good rating in the drop test The reverse will apply to hand carried boxes where weight will be more important Durability To what conditions will the cold box be exposed Ice packs Are ice packs included At the time of placing an order it is important to check if ice packs are included with the box or not If they are not included select ice packs that will fit the chosen box and simultaneously place an order for them Always order two sets of ice packs one set to be used while the other is being frozen Price Which cold box meets requirements 1 2 and 3 for lowest cost Remember to consider shipping costs Choose the cold box that costs the least yet still fulfils programme requirements However it is important to note here that the prices on the sheets do not include shipping costs Insulated boxes are bulky so shipping costs can often represent a high proportion of the total cost We therefore strongly recommend that programme managers investigate shipping costs before making a final choice BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Checklist for selecting a platelet agitator 1 What size of platelet agitator do you need These vary in quantity and
107. pares are likely to be simpler and less expensive However it is important to be aware of the risk of putting all one s eggs in one basket A manufacturer or supplier who knows there is no competition may unjustifiably increase prices Furthermore there is risk of being held to ransom when spares for the equipment are required The decision to standardize or not is thus an important one and should be carefully considered by the authorities It may be desirable to standardize on up to 3 different manufacturers depending on the national context Installation requirements Installation requirements will to some extent be deter mined by the location of the facilities where the equipment will be used It is important to state whether the supplier will be expected to install each unit of equipment at the sites where they will be used or whether the equipment should be delivered to one central site In the latter case the installation will be the responsibility of the buyer 55 It will generally be more expensive per unit if the supplier is expected to install all the equipment although this will depend on geographical and other considerations prevailing in the country The importance of users and technicians training is often underestimated and therefore under budgeted A cold chain with good equipment but insufficiently trained staff may seriously endanger blood safety Training must be taken into consideration before selecting
108. paring tendering specifications 11 3 Factors to consider in selecting blood cold chain equipment 11 4 Donated equipment 11 5 Quantity 11 6 Methods of payment 11 7 Checklists 11 8 Purchasing equipment Annex 1 Self Assessment Questionnaire on the Status of the Blood Cold Chain Annex 2 Chlorofluorocarbons CFC in Blood Cold Chain Equipment Annex 3 Description of codes used on page vi 26 26 26 27 30 30 31 31 35 35 35 35 35 36 37 41 41 41 43 44 45 45 45 46 46 48 48 49 49 50 52 53 54 55 57 59 61 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES B important note to readers major objective of the WHO Department of Blood Safety and Clinical Technology BCT is to assist every Member State to ensure a safe and adequate blood supply that meets national needs at reasonable cost Many countries face challenges in reaching this goal These include limited resources and information a lack of national policy and plans transfusion trans missible infections such as the human immuno deficiency virus HIV and appropriate technology Access to and use of appropriate technology are essential for the safe storage and transportation of blood from donation to transfusion a process referred to as the blood cold chain The WHO Blood Cold Chain Project is meeting this challenge by providing appropriate technical and logistics information that will empower managers of
109. proprietary products are distinguished by initial capital letters Designed by minimum graphics Printed in France B Contents Important note to readers List of products featured in this guide Abbreviations Glossary Preface Chapter 1 Chapter 2 Chapter 3 Introduction to the WHO Blood Cold Chain Project 1 1 1 2 The global challenge Objectives of the WHO Blood Cold Chain Project The blood cold chain process 2 4 2 2 2 3 2 4 2 5 WHO definition of blood components The national blood cold chain The blood cold chain as a work process Blood cold chain personnel Summary Blood bank refrigerators 3 1 3 2 3 3 3 4 Overview Standard electric blood bank refrigerator Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Solar powered blood bank refrigerators Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Ice lined blood bank refrigerators Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 4 Plasma freezers Description functions and limitations of the equipment WHO minimum performance specifications Product information on equipment evaluated by WHO Chapter 5 Platelet agitators Description fun
110. re than 15 hrs cold life per kg of ice melted at 43 C Cold Packs To conform to specification E5 IP1 or 2 Sufficient ice packs for freezing at 20 C are provided to surround the sides Means of Handling To be suspended from the shoulder or held in one hand Blood transport boxes extended cold life Specification Reference B4 BC2 Purpose of Equipment To carry whole blood from individual donors to blood bank or from blood bank to point of use Laboratory Test Procedure Standard Test Procedure B4 PROC 2 Robustness Fittings 2 casing 2 see ratings in test procedure Net Capacity for Blood Bags 15 to 27 litres approx 20 bags Maximum Weight Permitted 45 kg Cold Life Maintenance of under 10 C for minimum 130 hrs in ambient temperature of 43 C Maximum Ice Melting Rate More than 10 hrs per 1 kg ice melted during 43 C cold life test Cold Packs To conform to specification E5 IP1 or 1 2 Sufficient water filled ice packs for freezing at 20 C are provided to surround the blood bags on all sides Means of Handling Carrying by vehicle Two handles to enable one person to carry it CHAPTER 7 BLOOD TRANSPORT BOXES AND COOLANTS PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO BLOOD TRANSPORT BOXES Large blood cold box long range MODEL MT25E CF BLUE 991 1539 11 E CODE BB 01 4 PIS B4 05 M COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxemb
111. s How to select spares for blood cold chain equipment The availability of spare parts does not guarantee the uninterrupted and proper performance of the blood cold chain equipment It is difficult to estimate the optimal types and quantities of spares to buy and hold in stock It will assist to know the spare parts needed for repairs and for preventive maintenance bearing in mind that these are not mutually exclusive The manufacturer s list of recommended spares is invaluable in compiling an inventory which should be carefully conserved by management Tables 4 and 5 below may assist in the decision making process to procure spare parts Table 5 further shows the different types of spares that may be required This table is most important as it helps the buyer to identify which spares to obtain from the manufacturer and which can be substituted from other sources Table 4 Critical and non critical spare parts Breakdown in these spare parts is usually caused by normal wear and tear or component failure due to operator error Spare Parts Source Action Critical Available only from Spare part obtained manufacturer no from stock held or local substitute purchased possible Local or external repair service Non Critical Part or suitable Effect repairs or send substitute available on the local market for local repair 45 Table 5 Types of spare parts and their source Type of spare part Source Definition
112. s cold boxes and vaccines carriers The Montreal Protocol The international community has committed itself to the elimination of these refrigerants and foaming agents in an agreement called the Montreal Protocol The Montreal Protocol which calls for the cessation of CFC consumption i e production importation or expor tation as of 1 January 1996 in industrialized countries and from 1 January 2010 in developing countries has had the following results 1 R11 is no longer used as a foaming agent by any of the manufacturers in industrialized countries listed in the WHO Product Information Sheets It is now replaced by cyclopentane in European countries and by R141b in the USA the use of R141b will even tually also be banned in 2030 2 R12 is not used by the majority of the industrialized country manufacturers It is commonly replaced with HFC 134a Some manufacturers primarily in Germany also use R600 that is an isobutane How ever some countries the United Kingdom and the United States of America still allow the export of appliances using R12 This is why some of these More detailed information on the Montreal Protocol and ozone layer depletion replacements for ozone depleting substances and suppliers of alternative technologies can be obtained from UNEP DTIE OzonAction Programme Tor Mirabeau 39 43 quai Andre Citroen 75739 Paris Cedex 15 France Tel 33 1 44 37 14 50 Fax 33 1 44 37 14 74 E mail
113. s H x W x L in cm 15 x 15 x 19 Blood storage dimensions H x W x Lin cm 10 x 10 x 18 Lid type and fixings Removable No of ice packs required 4 No of ice packs supplied 4 Ice pack type Thermos Robustness in drop test Fittings 3 Casing 3 Cold life without openings 30 hrs at 43 C Standards complied with Test reports CRL A 9000 1990 Meets WHO GBSI Standard B4 BC 1 Shipping volume gross weight Minimum order 1 Small blood cold box short range E MODEL 55 CF E CODE BB 03 2 PIS B4 57M E COMPANY NAME AND ADDRESS Blow Kings 53 C Mittal Court Nariman Point Mumbai 400 021 India Tel 91 22 284 0120 Fax 91 22 283 1412 E mail blowkingsQvsnl com SPECIFICATIONS Blood storage capacity 10 units Weight fully loaded 21 7 kg Weight empty 8 2 kg External surface material Plastic Internal lining material Plastic Insulation material Polyurethane Insulation thickness 55 mm External dimensions H x W x L in cm 49 x 42 x 41 Internal dimensions H x W x L in cm 37 x 30 x 26 Blood storage dimensions H x W x L in cm 28 x 22x 16 Lid type and fixings Hinged No of ice packs required 24 No of ice packs supplied 24 E5 12 of 0 3 litre Cold life is 63 hrs when E5 19 0 4 litre is used Ice pack types E5 12 19 Robustness in drop test Fittings 2 Casing 5 Cold life without openings hrs at 32 C 65 hrs at 43 C Standards complied with Test reports Blow Kings a
114. s are still awaited WHO PIS codes included for ease of reference where applicable 1 Codes are 1 product descrption ii product number iii product capacity if relevant iv product type if relevant Therefore for example BR 06 1b means Blood Refrigerator WHO BCT Product No 06 with a capacity to hold fewer than 50 blood packs solar powered type product see Annex 3 for full description vi Abbreviations AC BCC BCT BTTI BTS cc CIF CFC CR dB A DC DIN dxl EN EXW FOB FOT HCFC hr s Hz not tested Alternate current WHO Blood Cold Chain Project WHO Department of Blood Safety and Clinical Technology Blood Time Temperature Indicator Blood Transfusion Services cubic centimetre Cost of item insurance and freight to nearest port of destination excluding customs clearance charges to be borne by buyer Chlorofluorocarbon found in some types of refrigerant gases Corrosion Resistance decibels Direct current Deutsche Industrie Norm any of a series of technical standards diameter by length European Norms Ex Works factory price everything else to be paid and organized by the buyer Free on Board Cost of item and delivery cost cleared for export to the seller s freight agent All other expenses are for the buyer free on truck Hydrochlorofluorocarbon hour s hertz cycles per second IEC ISO kg s kV A Kwh LED Its or 1 m max min PIS PVC
115. s by capacity WHO Specification BTS RF1 Classification by Capacity BR1 BR3 BRA BR5 Approx number of 450 ml blood bags 50 51 to 150 151 to 250 251 to 500 501 to 1000 Approx internal capacity of equipment litres 130 131 390 391 650 651 1350 1351 2700 Table 7 Classification of plasma storage freezers by capacity WHO Specification BTS FR1 Classification by capacity PF1 PF3 PF4 PF5 Approx number of 300 ml plasma packs lt 50 51 to 150 151 to 250 251 to 500 501 to 1000 Approx internal capacity of equipment litres lt 75 76 200 201 300 301 625 626 1300 52 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Table 8 Classification of blood transport boxes by capacity and cold life WHO Specification reference applies to each individual box Classification by capacity BB1 BB2 BB4 and cold life hand small capacity large capacity large capacity carrier short range short range long range Approx number of blood bags 450 ml lt 4 5 10 gt 20 Approx internal storage capacity in litres 1 4 4 15 15 27 Cold Life in hours with the recommended 30 132 140 ice packs or coolant pouches NB Transport Boxes are classified only according to the volume available for blood storage not for ice packs The manufacturer makes provision for the ice packs Figure 6 A guide to estimating the type and quantity of blood refrigerators plasma freezers and transp
116. s front door or other design to enable the user to view the contents in the cabinet without affecting the temperature and roll out drawers or shelves for holding the blood Some equipment may be fitted with two compressors Although only one compressor works at any one time this design reduces down time due to compressor failure The compression type of blood bank refrigerator is therefore the only type recommended for blood storage and the only type described in this Guide While the domestic type of electric compression refrigerator may be locally made and therefore readily available and supported by industry its design is not suitable for blood storage principally because it is usually poorly insulated and not designed to maintain the temperatures recommended it warms up quickly when electricity fails it may not operate in high ambient temperatures 43 C temperatures often fall below freezing in areas close See page 54 for a detailed checklist on selecting a blood bank refrigerator 10 to the freezing compartment especially in models without While the domestic type of electri sufficient insulation of the refrigerating compartment compression the doors are poorly insulated refrigerator may and be locally made its design is not suitable for blood storage temperature monitoring devices are not routinely fitted Generally whole blood is loaded into a refrigera
117. sion refrigerator which uses CFC free refrigerant gas and electricity from solar energy Laboratory Test Procedure Standard Test Procedure BTS Proc 5 Construction Chest type Internal Aluminium lining or similar External Corrosion Resistant CR at least 1mm thickness CFC free insulation Blood pack racks for easy packing or retrieval of packs Solid door Electrical Characteristics Input voltage Direct Current to Required Voltage Equipment meets electrical safety specifications such as that of IEC Minimum Compressor Starting Voltage 22 below nominal voltage Internal Temperature Control Electronic temperature control range 2 C to 6 C with setting accuracy of 1 C whatever the load External Ambient Temperature Performs in an ambient temperature of up to 43 C and 60 humidity Hold Over Time A full load of blood packs at 4 C 1 takes at least 2 hrs to rise to above 6 C Cooling Down Time A full load of blood packs at 37 C takes a maximum of 10 hrs for all the packs to reach below 6 C Temperature Monitoring Digital temperature display with 0 1 C graduation Temperature recording device Visual and audible alarm system indicating unsafe temperatures Battery status visual display Temperature recorder facility Facility for remote alarm contact PRODUCT INFORMATION ON EQUIPMENT EVALUATED BY WHO SOLAR POWERED BLOOD BANK REFRIGERATORS B MODEL NO VC65F E CODE BR 06 1B E COMPANY NAM
118. ss steel Description of shelves and drawers 3 stainless steel drawers Doors Lockable Internal air cooling mechanism Blower coil Automatic defrosting Internal lighting No Temperature indicator and alarm system Digital display to 1 mains power failure alarm high low temperature audible and visual alarms Battery back up Thermographs Optional Interface for Remote Temperature Monitoring Optional E SPECIFICATIONS Internal capacity litres 153 Maximum no of blood packs loaded 60 x 450 ml bags External dimensions in cm H x W x L 49 x 49 x 55 Gross volume litres 0 52m Weight kg 95 E PERFORMANCE DATA Full Quarter Empty load load Internal temperature minimum 2 5 C 2 8 C Internal temperature maximum 5 1 C 4 6 C mE Hold over time 56 min 46 min Cool down time 3 4hrs 1 6hrs Energy consumption 453 Kwh 24 hrs E ENERGY REQUIREMENTS Rated voltage frequency 230V 50Hz 115V 60Hz Energy source AC Electricity Min compressor starting voltage at 32 C ambient temperature 76V on 115V 60Hz Minimum compressor starting voltage at operating temperature 78V on 115V 60Hz E ADDITIONAL INFORMATION International standards equipment complies with AABB ANRC and FDA Shipping volume gross weight 1 94 2 288 kg 14 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES 3 3 Solar powered blood bank refrigerators DESCRIPTION FUNCTION AND LI
119. st programmes opt for diesel Diesel units tend to be more robust and few manufacturers make petrol units large enough to support an extensive cold chain Domestic petrol generators of the kind used in homes and shops are relatively cheap and easy to move around However they are not meant for continuous operation over a period of years and given their light weight can be stolen easily Manual versus electric automatic starting Hand starting is far less expensive and more robust However automatic starting may be needed when power cuts are frequent and cold chain staff are absent on nights or weekends since the battery will automatically take over Hand starting is preferable for units up to 3 cylinders For units up to 6 cylinders it is preferable to have both options When electric starting is selected be sure to include a starting battery in the budget request since batteries are not normally supplied unless specified Spring starters are an alternative that eliminates the need for a starting battery and charging equipment Type of cooling Air cooled units are easier to maintain than units with water cooling Mounting A separately mounted fuel tank is often preferable to an engine mounted tank which is subject to vibrations Meter A meter to record the number of hours run is a very useful feature It helps the operator plan preventive maintenance Spare parts The following should be included
120. tandard B4 CB 4 Shipping volume gross weight 0 15 m 15 6 kg Minimum order 1 CHAPTER 7 BLOOD TRANSPORT BOXES AND COOLANTS Large blood cold box long range MODEL NO ICBB 13F E CODE BB 05 3 PIS B4 72M E COMPANY NAME AND ADDRESS Apex Continental Ltd Surya Kiran 19 Kasturba Gandhi Marg New Delhi 110 001 India Tel 91 11 541 1459 Fax 91 11 546 4967 E mail apexcont mantraonline com SPECIFICATIONS Blood storage capacity 20 units Weight fully loaded 62 0 kg Weight empty 18 6 kg External surface material LLDPE Internal lining material Insulation material Polyurethane Insulation thickness in cm 10 External dimensions H x W x L in cm 52 x 77 x 62 Internal dimensions H x W x L in cm 27 x 51 x 36 Blood storage dimensions H x W x L in cm 18 x 45 x 30 Lid type and fixings Hinged No of ice packs required 50 No of ice packs supplied 50 Ice pack types E5 15 9 21 Robustness in drop test Fittings 3 Casing 2 Cold life without openings hrs at 32 C 101 hrs at 43 C Standards complied with Test report PSB August 1997 Meets WHO UNICEF Standard E4 CB 2 Shipping volume gross weight 0 28 m 25 4 kg Minimum order 1 Cold life with blood calculated on basis of tests described in CRL A 9000 which established difference between performance with vaccine and blood 1 LLDPE Linear low density polyethylene 33 Large blood cold box long range MODEL 20
121. tants donor attendants drivers Hospital clinic staff donor clerks Packing of donated blood Reception of blood and blood components from the blood bank Monitoring temperature during transport on Monitoring temperature of stored blood compo long distances nents at the blood bank or at the wards Delivering blood to the blood bank at the required Operate blood warmers temperatures and within the specified time Laboratory technical staff Receiving donated blood Storing blood components according to the Ensure safe transfusion of blood and blood com ponents It is essential that all managers and users of blood cold chain equipment are trained in their correct main tenance and use Standard Operating Procedures SOPs Monitoring temperature of stored products Packing blood and blood components according to length and time of travel Quality control of blood cold chain and products Reception and installation of blood equipment 2 5 Summary Many elements play an important role in ensuring the safe storage and transportation of blood from its equipment donation to transfusion The elements of the blood cold chain are cold chain Blood cold chain equipment for storage and for transportation Verifying the operation of new or repaired blood cold chain equipment Temperature monitoring devices BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMEN
122. tic defrosting Internal lighting Fluorescent light full height Temperature indicator and alarm system Digital display to 1 C door ajar alarm mains power failure alarm high low temperature audible and visual alarms Battery back up Thermographs Model 7ER Interface for Remote Temperature Monitoring Optional E SPECIFICATIONS Internal capacity litres 702 Maximum no of blood or plasma packs loaded 360 x 450 ml blood bags External dimensions in cm H x W x L 210 x 91 x 74 Gross volume litres 760 Weight kg 281 5 kg E PERFORMANCE DATA Full Quarter Empty load load Internal temperature minimum 2 7 C 3 0 C Internal temperature maximum 4 3 C 44 C Hold over time 62 min 62 min Cool down time 7 hrs 3 4 hrs Energy consumption 16 68 Kwh 24h E ENERGY REQUIREMENTS Rated voltage frequency 230V 50Hz 115V 60Hz Energy source AC electricity Min compressor starting voltage at 32 C ambient temperature 154V Minimum compressor starting voltage at operating temperature 154V Bi ADDITIONAL INFORMATION International standards equipment complies with AABB ANRC amp PDA Shipping volume gross weight 1 94 m 288 kg MODEL NO CT1 2A E CODE BR 05 2A E COMPANY NAME AND ADDRESS Jewett Refrigeration Inc 275 Aiken Road Asheville NC 28804 USA Tel 1 828 658 2845 Fax 1 828 645 9466 www jewettonline com E FEATURES Type of internal lining of the cabinet Stainle
123. tic pump Board Heater E MODEL NO CYTOTHERM D4 E CODE PT 02 E COMPANY NAME AND ADDRESS PhotoTherm 110 Sewell Avenue Trenton NJ 08610 USA Tel 1 609 396 1456 Fax 1 609 396 9395 E mail serve phototherm com www cytotherm com E FEATURES Materials White PVC Metalecyne bladders separate tempered water from plasma bags Has two isolated sections Temperature indicator Large digital thermometer Alarm systems Over temperature alarm and turn off when temperature reaches 38 C independent thermostat that turns off heaters at 42 C low water level alarm and heating turn off Senses plasma leaks Loading plasma packs Plasma packs are placed on the bladder and the lid closed Plasma bags and hands stay dry Plasma bag is massaged by pressurizing different sections of the bladder Temperature control Digital 21 E SPECIFICATIONS Capacity in the bath litres 8 Max no of plasma packs 4x450ml or 2x1000ml External dimensions in cm H x W x L 34 x 33 x 52 Gross volume litres 58 Weight kg 11 5 E PERFORMANCE DATA Full Min load load Thawing time 300ml bag of 15 mins 15 mins 250ml plasma 6bags 1 bag Water bath temperature 37 C Noise level Low E ENERGY REQUIREMENTS Rated voltage frequency 120 or 240V 50 60Hz Energy source AC Electricity Min voltage 105 VAC for 120 VAC unit 210 VAC for 220VAC unit Max voltage 135 VAC for 120 VAC unit 270 VAC for 220VAC un
124. tion of CFC free equipment region by region or district by district in order to facilitate the repairs and service if required 60 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES Description of codes used on page vi BR 01 1 a Blood Bank Refrigerator Product Number assigned by WHO a standard electric b solar powered c ice lined Capacity see also Table 6 p52 1 lt 50 450ml blood bags 2 51 150 bags 3 151 250 bags 4 251 500 bags 5 gt 500 bags PF 01 1 Plasma Freezer Product Number assigned by WHO Capacity see alsoTable 7 p52 1 lt 50 300ml plasma pks 2 51 150 plasma pks 3 151v250 plasma pks 4 251 500 plasma pks 5 gt 500 plasma pks PA 01 f Platelet Agitator Product Number assigned by WHO f flatbed i agitator in an incubator PT 01 Plasma Thawer Product Number assigned by WHO BB 01 1 Blood Transport Box Product Number assigned by WHO Capacity see also Table 8 p53 1 lt 4 blood bags 2 5 10 bags 3 11 20 bags 4 gt 20 bags TD 01 Temperature Product Number assigned by WHO Monitoring Device VR 01 Voltage Regulator Product Number assigned by WHO 61 Some key factors to consider when procuring blood cold chain equipment Blood cold chain equipment must meet international standards WHO minimum performance specifications and be correctly used an
125. tions and product information on equipment evaluated by WHO but also basic information on the blood cold chain and guidelines on its management A chapter on equipment maintenance has been especially included following recognition of the lack of knowledge on preventive maintenance and management of the inventory of spare parts in many countries Manufacturing prices and exchange rates are not provided since these may well be out of date before the Guide is printed In carrying out its work the WHO Blood Cold Chain Project has been supported by manufacturers of blood cold chain equipment and national authorities who have participated in field evaluation programmes Manufacturers equipment evaluated under the WHO Project appear in this Guide as examples of blood cold chain equipment only It is hoped that the data obtained from the equipment evaluated and the minimum performance specifications identified will enable other manufacturers to promote equipment that meets or surpasses these specifications for blood storage and transportation Future editions of this Guide may include such equipment in collaboration with the manufac turers and subject to the rights of WHO Furthermore itis hoped that this Guide will assist managers and users of blood cold chain equipment to evaluate blood cold chain equipment in general A cost effective blood cold chain programme can only be achieved if technologically appropriate equipment for the storage
126. tor at room temperature The bigger the total volume the longer it will take to cool the blood to the acceptable temperature of storage of 4 C Sub divided into smaller volumes the blood will cool faster but this will require more storage space for the same total given load of blood Chapter 11 shows a chart which assists managers to select the best compression type of blood bank refrigerators Wherever there is a need for more than 8 hours of electricity per 24 hours the compression type of refrigerator is the preferred choice In addition to the standard electric refrigerator the different types of ice lined and solar powered compression type blood bank refrigerators are described below 3 2 Standard electric blood bank refrigerator DESCRIPTION FUNCTION AND LIMITATIONS OF THE EQUIPMENT This equipment is the preferred choice in many laboratories assured of a electricity supply 24 hrs day from the national electricity grid The equipment is also connected to a standby electricity generator e g of the hospital or blood bank in case of a failure of the mains power supply Manufacturers provide different sizes to suit various needs see also Chapter 9 The key limitations for optimal performance are the hold over time during power failure in the absence of a standby generator and also the cooling down time WHO MINIMUM PERFORMANCE SPECIFICATIONS FOR Standard electric blood bank refrigerators Specification Reference BTS
127. ture indicators are not yet in common use In some developing countries especially in remote rural areas hospitals are often dependent on fuel driven generators for their electricity supplies which may be inadequate to meet their power needs particularly the special requirements of blood bank refrigerators and freezers that must function permanently Frequent power cuts sometimes of long duration occur in hospitals that are on the national power grid In such situations safe storage may not be possible and blood components often have to be discarded In addition sensitive blood bank refrigerators in common use in developed countries are often damaged because of power surges in the developing world where replacements are not easily obtained A high ambient temperature and humidity in the laboratory as well as in the environment where blood is collected and transported adversely affect the perfor mance of blood storage equipment Such adverse environmental situations place stress on the equipment and their ability to maintain temperatures within acceptable ranges is reduced In addition to the above factors maintenance of blood cold chain equipment is often ill organized Information and human resources for the maintenance of the equipment are not available or formalized and this is further aggravated by a frequent lack of spare parts The transportation of blood between and within blood banks and hospitals is often depen
128. ty for the blood stocks Hold over time What hold over time is needed in case of power failure How many minutes hours will the blood remain within 2 C 6 C How many hours will the plasma remain below 20 C Reliability Repair facilities and spare parts available for which types Spare parts and repairs account for 40 50 of the whole life cost of a refrigerator Price Which refrigerator or freezer meets require ments 1 6 at the lowest cost Remember to consider shipping costs Temperature Monitoring Do you have a fixed temperature display and alarm system Do you need user and service manuals in the official language of your country Training Are the users and those in charge of maintenance of the equipment properly trained 1 Checklist for selecting a blood transport box Blood pack storage capacity How many units of blood will be carried To calculate the quantity of blood packs that must be transported see the information given on storage volumes Cold life How long will box and ice packs keep the correct temperature for This will depend on size of box load time and distance It is necessary to validate the different boxes and conditions locally so that your centre will have a clear idea of how many ice packs per box will be needed to transport blood products to different locations Weight How will the cold box be carried Weight fully loaded and durability can be graded according to h
129. uipment equipment The best source of information to decide whether or not a piece of equipment should be accompanied by a voltage regulator is the engineers responsible for the national electricity supply or the hospital electricity engineers depending on their level of knowledge Historical information on the performance of cold chain or other laboratory equipment should also assist in establishing the risk factors for voltage fluctuations and therefore the need for a regulator If a voltage regulator is recommended then the appropriate type must be selected Types of voltage regulator The electronic servo regulator is composed of electronic elements motors and transformers The electronics monitor the input voltage If the input voltage is not sufficient a signal is sent to the motor which in turn regulates the output voltage on the transformer The electronic and motor functions are sensitive and Accessories to the blood cold chain equipment without proper care may fail This regulator is one of the most accurate available and regulates a wide range of voltages It is also in most cases the least expensive The solid state regulator has no moving parts such as the motor described above It is therefore very reliable and efficient The pure transformer type also has no moving parts It operates through a combination of the magnetic flux and transformer concepts which together monitor the input voltage B
130. umption 0 53 Kwh 24h E ENERGY REQUIREMENTS Rated voltage frequency Energy source 12V DC Nominal Min compressor starting voltage at 32 C ambient temperature Minimum compressor starting voltage at operating temperature E ADDITIONAL INFORMATION Requires solar energy system This will be supplied according to WHO UNICEF approved solar refrigerator supplier status for solar vaccine refrigerators International standards equipment complies with EU Safety Approval Shipping volume gross weight 1 0m 140 kg E MODEL NO 50DC CF 991 2340 01 E CODE BR 07 1B E COMPANY NAME AND ADDRESS Dometic ex Electrolux 17 op der Hei 9809 Hosingen Luxembourg Tel 4 35 2 92 07 31 Fax 35 2 92 07 31 300 E mail pascal vannier dometic lu www dometic lu E FEATURES Type of internal lining of the cabinet Polyethelene Description of shelves and drawers 2 wire baskets Doors Lid Internal air cooling mechanism Fan Internal lighting No Temperature indicator and alarm system Digital display with alarm functions Thermographs Optional in the unit Interface for Remote Temperature Monitoring No E SPECIFICATIONS Internal capacity litres 14 4 Maximum no of blood packs loaded 32 x 450 ml blood bags CHAPTER 3 BLOOD BANK REFRIGERATORS External dimensions in cm H x W x L 83 x 82 x 92 Gross volume litres 70 Weight kg 60 E PERFORMANCE DATA Full Half Quarter load load
131. use Pre filled ice packs are not normally recommended They contain a eutectic agent that may have a lower freezing point than water thus endangering whole blood or packed red cells which should never be frozen Estimation of the cold life without openings The cold life of a blood transport box has been estima ted in in one model by putting a blood load in place of a vaccine load for approved use in ambient temperatures See page 54 for a detailed checklist on selecting a blood transport box Document WHO V amp B 00 13 30 blood transport boxes between 20 C and 43 C The ratios between the performances with vaccine and blood were then used to calculate the cold life anticipated in the remaining models that have not been tested with a blood load More work is still to be done by BCT to improve the design of blood transport boxes e g to reduce the overall weight and provide a facility for temperature monitoring Blood platelet coolant The coolant is a eutectic solution that has tremendous thermal energy capacity and stability at its thermal phase change temperature typically 16 to 20 C The coolants are kept at 4 C when they solidify and are ready for use after two hours at room temperature This phase change from solid to liquid thermally protects blood or platelets and is far more efficient than ice water whose thermal phase change is at 0 C The coolant is in a sealed pouch housed inside another
132. ut a lower purchase price Local availability of technical expertise and spare parts Visit the local office of the Food and Agricultural Organization FAO the fishery department or ice factory to see which models of heavy duty generators are most commonly used in your country You can also check with them whether technicians are available locally to assist with maintenance if your programme doesn t have its own generator technicians Revolutions per minute RPM Generators with low RPM ratings such as 1500 to 1800 RPM are slow running and have longer working lives Models with RPMs of less than 1000 are rarely available Faster running models with RPMs of 3000 to 3600 are found to require more maintenance have a greater fuel consumption and wear at a higher rate A cheaper model with a high RPM may therefore not be a better choice over a more expensive model with a low RPM 9 3 Blood and plasma trays or pack holders Some manufacturers of blood cold chain equipment may provide pack holders or trays for holding blood or plasma packs in their equipment The accessories are thus designed to fit into the shelves of the blood cold chain equipment Trays provide for easier handling of blood products in comparison to pack holders which may only handle one unit Trays and pack holders provide for easier inventory management and should be the choice in place of putting the blood or plasma packs unsupported on the shelves Furthermore
133. utine maintenance of blood cold chain equipment It will focus particularly on the training needs of staff in small blood banks where responsibility for the monitoring and maintenance of blood cold chain equipment rests with employees who are unlikely to have been trained in basic refrigeration mechanics WHO is also developing a country model for the preventive maintenance repair and management of spare parts for blood cold chain equipment Since a successful blood cold chain depends on the efforts of health authorities to promote safe national blood programmes BCT is addressing quality management at all levels of the blood transfusion programme at international regional and country level To this end a questionnaire has been included in this Guide as an instrument to assist national authorities hospital blood banks etc to assess their needs for blood cold chain equipment see Annex 1 4 BLOOD COLD CHAIN GUIDE TO THE SELECTION AND PROCUREMENT OF EQUIPMENT AND ACCESSORIES The blood cold chain process CHAPTER 2 2 1 WHO definition of blood components The blood cold chain is a systematic process for the safe storage and transportation of blood from its collection from the donor to its administration to a patient who requires transfusion It is referred to as a cold chain because blood being a biological substance must be kept cold in order to reduce bacterial conta mination and to prolong its life Whole blood is
134. warm Blood must be stored when collected but must be and transported in equipment that meets defined standards of performance cooled down to 4 C and kept at this temperature until the point of transfusion The purpose of a transfusion is to provide blood compo that the haematological status of the patient Various blood nents improve components can be yielded from a donation of whole blood Most blood banks are able to separate red cells and plasma components Some are able to prepare other products such as platelet concentrates and cryopreci pitate These products are often referred to as wet products Other plasma products generally referred to as plasma derivatives can be extracted from plasma by a pharmaceutical process called plasma fractionation All of these products have a specific benefit to the patient However in order for the blood component or plasma derivative to provide that benefit it must be transfused in a viable state Blood must be stored and transported in equipment that meets defined standards of perfor mance and by staff who correctly follow established procedures at all times 2 2 The national blood cold chain Blood may be collected from donors going to a blood bank or to a mobile blood donor session The blood is then taken to a laboratory for processing into compo nents and for storage and distribution as the need arises The blood cold chain begins at the time the bl
135. y for monitoring the temperature of blood cold chain equipment has evolved from the traditional thermo meter to electronic versions that have an accuracy of at least x 0 2 C However according to a recent survey conducted by WHO on the status of the national blood cold chain the traditional max min thermometers are still in Quality management requires that a record is kept of the temperatures of equipment storing blood and blood components the chart recorder readily provides thi use in many developing countries Similarly the traditional tem perature recorder chart remains the simple effective tool used by the majority of peripheral centres for monitoring the temperature of co a blood bank refrigerator or plasma freezer Quality manage ment requires that a record is kept of the temperatures of equipment storing blood and blood components and the chart recorder readily provides this Its major drawback is the requisite consumables such as ink chart paper and pens which often run out well before the equipment becomes obsolete Improvements to meet these shortcomings are now commercially available mainly in the electronic display and capture of data 8 2 Electronic versions of temperature monitoring devices These have now become part of the cold chain equipment The temperature warning lights and controls can be displayed on an LED unit affixed to the front of the equipment Audio alarms sound if the
136. y inducing magnetic fields they regulate the output voltage when needed The electronics on this type are generally very simple It is the most reliable type available but also the most expensive Information needed by a voltage regulator supplier The supplier of a voltage regulator may require other information before the correct regulator is identified such as the following Number of pieces of equipment that require to be protected Planned purchases of cold chain or related equipment e g refrigerated centrifuges that will draw power on the same line Minimum and maximum measured input voltage 9 2 Standby generators Most blood cold chains in developing countries need a standby generator unless the mains current is very reliable However if power cuts are a chronic problem it is important to review alternative solutions such as the use of ice lined or solar powered equipment because the procurement and installation of a standby generator is expensive If the blood bank is part of the hospital the issues are generally simpler The manager will seek to ensure that the input voltage line to the blood cold chain equipment 41 is wired also to the hospital emergency power generator If the blood bank is separate from the hospital facilities i e stand alone there is a need to obtain the appropriate equipment for use bearing in mind future needs Estimating the size of the generator for the stand alone blo

The Blood Cold Chain - World Health Organization

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