GE_UM_NFF SIP_E - GE Healthcare Life Sciences
Contents
1. Installation use of GE Healthcare air filter housings which utilize a plenum chamber are recommended as this facilitates the col lection and drainage of condensate Valve V7 should be placed as close as possible to the filter housing If long lengths of pipe are present the initial steam flows will be high as the downstream volume is pressurized This high steam flow can change the cartridge User Manual 9 www gelifesciences com fi Itration GE imagination at work and GE monogram are trademarks of General Electric Company All goods and services are sold subject to the terms and conditions G E Hea lthca e Bio Sciences AB of sale of the company within GE Healthcare which supplies them ree A copy of these terms and conditions is available on request BJ rkgata n 3 0 7 5 1 84 U ppsa la Swede n Contact your local GE Healthcare representative for the most cur rent information 2007 General Electric Company All rights reserved GE Healthcare Bio Sciences AB a General Electric Company GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare UK Ltd Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Bio Sciences Corp 800 Centennial Avenue PO Box 1327 Piscataway NJ 08855 1327 USA GE Healthcare Bio Sciences KK Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan Asia Pacific Tel 65 6275 1830 Fax 65 6275 1829 Australasia Tel2. 5 Installation use of GE Healthcare air filter housings which utilize a plenum chamber are recommended as this facilitates the collection and drainage of condensate 6 When steaming in the reverse direction please contact GE Healthcare Technical Support for guidance Reverse Steam in Place procedure air filter applications IL 2 FEFESSASSE Set the valves to positions indicated for pre Steam In Place Open valve V1 and allow the steam condensate to drain until the steam trap below valve V2 closes Slowly open V2 allowing steam into the system Observe the pressure gauges P1 and P2 and control the steam flow rate at valve V2 to ensure the P across the filter does not exceed 0 1 barg If the P exceeds 100 mbar stop the steriliza tion procedure and rectify the cause of the pressure drop before proceeding with the sterilization routine When line steam flows from valve V6 close valve V6 When the steam trap below valve V5 closes the steam pressure will begin to rise Ensure steam pressure temperature does not exceed the maxi mum allowable pressure temperature for the cartridge type WG Saar ep Sean ae Gi DOC BOC being steamed Continue to monitor the P using gauges P1 and P2 If the differential pressure exceeds 100 mbar stop the sterili zation procedure and rectify the cause of the pressure drop before proceeding with the sterilization routine Steam sterilize the cartridges for 3
3. 61 2 9899 0999 Fax 61 2 9899 7511 Austria Tel 01 57606 1619 Fax 01 57606 1627 Belgium Tel 0800 73 888 Fax 02 416 82 06 Canada Tel 800 463 5800 Fax 800 567 1008 Central East amp South East Europe Tel 43 1 972720 Fax 43 1 97272 2750 Denmark Tel 45 16 2400 Fax 45 16 2424 Finland amp Baltics Tel 358 0 9 512 39 40 Fax 358 0 9 512 39 439 France Tel 01 69 35 67 00 Fax 01 69 41 96 77 Germany Tel 089 96281 660 Fax 089 96281 620 Greater China Tel 852 2100 6300 Fax 852 2100 6338 Italy Tel 02 27322 1 Fax 02 27302 212 Japan Tel 81 3 5331 9336 Fax 81 3 5331 9370 Latin America Tel 55 11 3933 7300 Fax 55 11 3933 7304 Middle East amp Africa Tel 30 210 9600 687 Fax 30 210 9600 693 Netherlands Tel 0800 82 82 82 1 Fax 0800 82 82 82 4 Norway Tel 815 65 555 Fax 815 65 666 Portugal Tel 21 417 7035 Fax 21 417 3184 Russia amp other C I S amp N I S Tel 7 495 956 5177 Fax 7 495 956 5176 Spain Tel 93 594 49 50 Fax 93 594 49 55 Sweden Tel 018 612 1900 Fax 018 612 1910 Switzerland Tel 0848 8028 12 Fax 0848 8028 13 UK Tel 0800 616928 Fax 0800 616927 USA Tel 800 526 3593 Fax 877 295 8102 imagination at work 28 9137 77 AA 04 2007
4. in Place procedure liquid filter applications 1 2 Set the valves to positions indicated for pre Steam In Place Drain the product from the filter system and associated pipework Opening valve V5 will aid this process Open valve V1 and allow the steam condensate to drain until the steam trap below valve V3 closes Close valve V9 Slowly open V3 allowing steam into the system this will flow across the filters and through valve V4 amp V5 This will allow the heating of the housing the filters and associated pipework without generating a significant differential pressure across the filters Note The steam trap below valve V3 amp V4 will receive the condensate and will repeatedly open and close When live steam flows from valve V5 close valve V5 This will direct the steam through the heated filter close valve V10 Observe the pressure gauges P1 and P2 and control the steam flow rate at valve V3 to ensure the differential pressure does not exceed 0 2 0 3 barg dine ade vi va Vane Posen va zys a va Fase 6 Fou se vw hod vava Dama a an ze 7 When the steam trap below valve V6 closes the steam pressure will begin to rise 8 Ensure the steam pressure temperature does not exceed the maximum allowable pressure temperature for the cartridge type being steamed If reading from pressure gauges it is recommended the maximum steam pressure is 2 0 barg in the forward direction
5. life will depend on individual steam sterilization conditions SIP Single cycle Maximum temperature exposure time number Filter type C mins of cycles ULTA PURE SG 130 30 30 ULTA PURE HC 130 30 30 ULTA PRIME CG 130 30 30 ULTA PRIME PP 135 30 30 ULTA PRIME GF 121 30 10 Practical SIP The following sections in this guide provide step by step proce dures for developing SIP protocols in three operational conditions 1 Liquid filters steamed in the forward direction The steam flows in the same direction as the liquid product from outside to inside of the filter cartridge The filter has a membrane that is hydrophilic 2 Gas filters steamed in the forward direction The steam flows in the same direction as the gas product from outside to inside of the filter cartridge The filter has a membrane that is hydrophobic 3 Gas filters steamed in the reverse direction The steam flows in he opposite direction inside to outside of the filter cartridge to he designed direction of flow for the gas product The filter has a membrane that is hydrophobic Each procedure has a system diagram and valve sequence table to illustrate the step by step procedure The procedures represent ideal systems for SIP which may not be identical to existing sys tems For recommendations modifications or more information regarding these procedures please contact the GE Healthcare Technical Support Group 6 User Manual Forward Steam
6. minutes ensuring the con ditions stated in steps 5 to 7 are followed The valves should now be in positions indicated for Steam In Place 9 On completion of the Steam In Place cycle close V4 V6 V3 and V1 in that order 10 Fully open V5 to flash dry the filter or 10a 10a Open V2 to allow compressed air into the system The pres sure of the air should be no more than 0 5 barg above the steam pressure 11 Allow the system to cool for 15 minutes then close V5 flash dry only The valves should now be in the positions indicated for post Steam In Place NOTES 1 A double downstream valve V7 V8 is recommended so that under the cartridge steaming protocol the valves sealing faces of V7 can be effectively sterilized The sealing valve faces of V8 can be similarly sterilized when the tank is steamed When steam sterilizing the tank V7 would be closed and V6 and V8 open Normally the tank would be steamed separately before steaming the filter If the filter is steamed before steaming the tank it is recommended that valve V7 is closed in the post Steam In Place prior to maintain sterility step 9 2 Valve V7 should be installed horizontally and valve V6 steam trap installed immediately downstream of V7 3 All drains should be fitted vertically to allow liquid removal 4 Large volume downstream systems should not be steamed through the filter e g when steaming process tanks a second ary steam supply should be used
7. or steam trap e Length of pipeline relative to steam flow rate may result in pressure loss The length of steam supply pipework should be kept to a minimum Condensate removal While saturated steam behaves as a gas and so flows easily through filters contact with any cool surface e g stainless steel housings or pipework will lead to the generation of condensate as the steam cools In some systems very large volumes of conden sate may be generated due to this process e g multiple cartridge housings extended pipework etc In any case the removal of condensate from any SIP system is important for a number of rea sons 1 Condensate can blind both hydrophilic and hydrophobic mem branes to steam flow potentially leading to filter damage due to the development of high differential pressures across the mem brane at high temperature 2 Condensate will be at a temperature below the required steam sterilization temperature It is therefore important to remove condensate to ensure effective steam sterilization 3 Hydraulic shock may occur due to slugs of steam being forced through the line In designing process systems the effects of condensate generation can also be minimized by ensuring that housings are not located at the bottom of long pipe runs or that these are steam sterilized separately from the filter Steam traps As discussed above the removal of condensate from systems is important to ensure effic
8. removal 4 Large volume downstream systems should not be steamed through the filter e g when steaming process tanks a second ary steam supply should be used User Manual 7 Forward Steam in Place procedure air filter applications 1 Set the valves to positions indicated for pre Steam In Place 2 Open valve V1 and allow the steam condensate to drain until the steam trap below valve V3 closes 3 Slowly open V3 allowing steam into the system this will flow across the filters and through valve V4 amp V5 This will allow the heating of the housing the filters and associated pipework without generating a significant differential pressure across the filters Note The steam trap below valve V3 amp V4 will receive the condensate and will repeatedly open and close 4 When live steam flows from valve V5 close valve V5 This will direct the steam through the heated filter 5 Observe the pressure gauges P1 and P2 and control the steam flow rate at valve V3 to ensure the differential pressure does not exceed 0 2 0 3 barg 6 When the steam trap below valve V6 closes the steam pressure will begin to rise 8 User Manual 7 Ensure the steam pressure temperature does not exceed the maximum allowable pressure temperature for the cartridge type being steamed If reading from pressure gauges it is rec ommended the maximum steam pressure is 3 0 barg in the for ward direction 8 Steam sterilize the cartridges for 30
9. to cartridges and maximize the steam life of installed filters GE Healthcare Setting the standard GE Healthcare brings extensive experience through our scientists engineers and sales representatives to the process of offering specific filtration systems to meet the needs of your production process Support services are available covering a wide range of activities including scale up advice from laboratory through pilot scale to production systems validation support design and man ufacturing of custom housings and filtration products and on site technical support Committed to quality Quality is of paramount importance to GE Healthcare As such GE Healthcare is certified to ISO 9001 providing a quality management system that covers the entire organization from R amp D production warehousing materials Management and customer support In addition our manufacturing facilities operate to the principles of cGMP Validation and product certification To certify that GE Healthcare products meet the required regulatory and quality standards of the industries we supply all filters are supplied with a certificate of quality These certificates are linked to validation guides for both pre filter and sterilizing grade membrane filter cartridges that define methodologies and data appropriate to each filter type This information typically includes e technical specifications e biological safety testing including Current USP lt 88 gt Cla
10. 0 minutes The valves should now be in the positions indicated for Steam In Place This method is typically suited to single cartridge systems On completion of the steam cycle time close V5 V2 V1 in that order and then rapidly open V6 to flash dry the filter or 8a 8a Isolate steam supply and open V7 to allow air into the system The pressure of the air should be no more than 0 5 barg above the steam pressure 9 Allow the system to cool for 15 minutes then close V6 the valves should now be in positions indicated for post Steam In Place NOTES 1 A double downstream valve V4 V3 is recommended so that under the cartridge steaming protocol the valve sealing faces of V4 can be effectively sterilized the sealing valve faces of V3 can be similarly sterilized when the tank is steamed When steam sterilizing the tank V4 should be closed and valve V3 open To ensure adequate drainage at V3 there should be a slight fall in the pipework between V3 and the tank As the same steam supply is used to sterilize the tank as well as the fil ter A steam filter of a suitable flow rate capacity must be selected All drains should be fitted vertically to allow liquid removal There should be a fall in the pipework from V3 so that liquid can drain into the tank Large volume downstream systems should not be steamed through the filter e g when steaming process tanks a second ary steam supply should be used
11. 9 Steam sterilize the cartridges for 30 minutes ensuring the con ditions stated in steps 5 to 7 are followed The valves should now be in positions indicated for Steam In Place 10 On completion of the Steam In Place cycle close V4 V6 V3 and V1 in that order 11 Slowly open V10 to release the steam pressure from the filter system and associated pipework When the pressure on P2 reads 0 1 barg pressure close valve V10 Fully open valve V9 to release the remaining steam pressure from the filter system When the pressure on P1 reads 0 1 barg pressure close valve V9 12 Allow the system to cool for 30 minutes The valves should now be in the positions indicated for post Steam In Place NOTES 1 A double downstream valve V7 V8 is recommended so that under the cartridge steaming protocol the valves sealing faces of V7 can be effectively sterilized The sealing valve faces of V8 can be similarly sterilized when the tank is steamed When steam sterilizing the tank V7 would be closed and V6 and V8 open Normally the tank would be steamed separately before steaming the filter If the filter is steamed before steaming the tank it is recommended that valve V7 is closed in the post Steam In Place settings to maintain sterility The valve V7 must be closed during Step 10 2 Valve V7 should be installed horizontally and valve V6 steam trap installed immediately downstream of V7 3 All drains should be fitted vertically to allow liquid
12. GE Healthcare NFF Steam In Place Table of contents Introduction General principles Steam quality The temperature pressure relationship Differential pressure Filter housing installation Condensate removal Steam traps Integrity testing Cartridge filter steam life Practical SIP Steam in Place procedures Forward Steam in Place procedure liquid filter applications Forward Steam in Place procedure air filter applications Reverse Steam in Place procedure air filter applications 2 User Manual DOUNUNNUNDALLS L AS UN OoN N O Introduction The ability of a cartridge filter to be sterilized in situ within its housing represents a significant operational advantage for many filter users Steam in place SIP avoids the need to use chemical sanitizing agents or to compromise the integrity of the filtration installation minimizes operator hands on time and plant down time and can be easily incorporated into automated production facilities To achieve reproducible sterilization conditions typically a minimum of 121 C for 30 minutes and to avoid damage to the installed filter cartridge s it is important to carefully design and monitor SIP procedures Factors including steam temperature and quality condensate removal differential pressure and cooling cycles need to be considered The purpose of this document is to detail the recommended methods of SIP for GE Healthcare cartridge filters to avoid acci dental damage
13. e of filter blockage or worse cause damage to the filter Pipe corrosion can result in metal fragments which when carried to the filter could puncture the support materials and membrane Chemical Activities Chemicals are often added to the feed water in steam generators These chemicals will form part of the steam and so will contact the filter cartridge being steam sterilized Most standard steam generator additives do not pose any problem for the steam filter or filter cartridge being sterilized If you have any doubt regarding steam generator additives please contact Technical Support The temperature pressure relationship There is a direct relationship between steam temperature and pressure Increasing the steam pressure facilitates an increase in the temperature of the pressurized steam The following graph illustrates this relationship Temperature Pressure Relationship Temperature c 5 o 02 04 06 08 10 12 14 16 18 20 Pressure bar Gauge Thermodynamic and Transport Properties of Fluids SI units by G F C Rogers and Y R Mayhew Oxford Basil Blackwell 1981 0631 128913 4 User Manual As saturated steam is pressurized its temperature increases To assure sterility it is typically recommended that a temperature of 121 C be maintained over at least 30 minutes A pressure of 1 1 barg is required to achieve this temperature actually equates to 121 8 C However 1 0 barg equates to 120 2 C and so would not be
14. ient steam sterilization A thermodynamic steam trap or condensate trap is a mechanical valve to remove condensate They are located at points upstream and down stream of the filter where condensate would collect i e low points in the system These steam traps work on the principle that as condensate collects the temperature at the trap falls below that required for effective steam sterilization 121 C At this point the valve opens drains the condensate and draws in live steam from the steam supply Steam traps can be replaced by a manual valve that is left slightly open but requires control by a skilled operator to ensure effective condensate removal without draining exces sive steam Integrity testing Steam sterilization under carefully controlled conditions is an accepted process operation for filter cartridges However this does represent an aggressive process condition and can lead to filter damage should steam sterilization conditions deviate from controlled norms It is therefore recommended that filter car tridges are integrity tested in situ after steam sterilization and before use For advice on in situ integrity testing of filter car tridges please refer to GE Healthcare Technical Support User Manual 5 Cartridge filter steam life Recommended maximum steam life for GE Healthcare filter car tridges at a range of temperatures is shown in Table 1 It should be noted that these are provided as guidelines as actual filter
15. ondensate formation in the cartridge filter This is particularly relevant for hydrophobic gas filter cartridges 6 Controlled cooling of filter cartridges post SIP to ensure hydrophobic filter cartridges are not blinded by condensate 7 Controlled cooling of filter cartridges post SIP to prevent poten tial thermal shock by crash cooling or cold product introduction Filter housing installation The following considerations should be given to the installation of filter housings that will be steam sterilized e The installation should ensure that condensate cannot accumu late in the housing Housings or upstream pipework should therefore be fitted with condensate drains Condensate removal is particularly important when steam steriliz ing hydrophobic gas filter cartridges e The cartridge and housing should be in a normal orientation vertical with the open end of the cartridge pointing downwards e The pipework downstream of the filter housing should be as short as possible GE Healthcare recommends a maximum of 100cm Tanks downstream of the filter should always be steam sterilized separately e Pressure gauges capable of accurate reading over the mini mum range of 0 3bar at the SIP temperature should be installed upstream and downstream of the filter housing to allow differential pressure measurement e The pipework should be positioned at a slight incline allowing gravity to collect the steam condensate at a steam drain
16. ore sterilization would require 1 1 bar gauge The differential pressure can be influenced by many factors including the micron rating of the cartridge filter the degree of blockage due to retained contamination the influence of conden sate and the rate of steam flow through the cartridge filter While filter cartridges can withstand high differential pressures up to 5 barg at ambient temperature it is important to limit differential pressure at elevated temperature When a cartridge filter is heated to 121 C or higher this procedure places significant stress on the unit During the SIP process the physical properties of the cartridge filter components are weak ened at elevated temperature e g increased plasticity of poly mers It is therefore important that at temperatures of 121 C or higher the differential pressure across the filter cartridge not exceed 0 3 barg Differential pressure above this level may lead to filter damage Consideration of process parameters to limit differential pressure during SIP is therefore critical and includes 1 Ensuring efficient condensate removal during the entire SIP cycle 2 Minimizing steam flow rates through the cartridge filter 3 Minimizing the downstream pipework steamed through the filter cartridge 4 Control and measurement of the temperature and differential pressure during filter cartridge SIP 5 Removal post SIP of as much of the steam as is practical to reduce c
17. ss VI 121 C Plastics e extractable testing including 21 CFR 211 72 and 210 3 b 6 for fiber releasing filters e effluent quality including TOC bacterial endotoxins water conductivity and particle release e chemical compatibility information e thermal stability e correlation of a non destructive integrity test to a defined bacterial challenge Validation support services GE Healthcare has extensive laboratory facilities and trained personnel capable of providing a range of validation support services to support manufacturers in meeting their requirements for process validation relating to the use of filtration products User Manual 3 General principles Steam Quality Condensate Optimum steam sterilization of filter cartridges can be achieved using dry steam Wet steam steam containing a high level of con densed water will not flow easily through the filter This resistance to flow will generate increased differential pressure across the fil ter at elevated temperatures conditions which cause the maxi mum stress to the filter cartridge Condensate should therefore be removed by a manual valve or an automated steam trap located as close to the filter as possible to avoid condensate contact with the filter Particulates Many steam lines suffer from corrosion over a prolonged time period This can introduce particulates into the steam which will be retained by the filter being steamed This will accelerate the rat
18. sufficient to give a high degree of assurance that sterility has been achieved It is therefore important that appropriate devices are installed to directly record either steam temperature or the pressure Differential pressure Filters should generally be supplied with steam from the upstream side normal flow direction Steam flow from the downstream side should be avoided Reverse flow should not be used for liquid fil ers Steam should not be applied to both sides of the filter at the same time as this can potentially trap a pocket of dry air between the steam supplies reducing the heat transfer to the filter and therefore negatively impacting the steam sterilization conditions During normal steam sterilization cycles as steam is applied to the filter housing air is purged from the system such that saturat ed steam contacts and heats all the filter and housing surfaces As the steam heats and subsequently flows through the cartridge filter there will be an inherent resistance to that flow The amount of resistance to the steam flow is measured as a drop in pressure across the filter and is called the differential pressure Differential si Upstream Steam Downstream Pressure Pressure Steam Pressure Steam pressure can be expressed in two forms 1 Absolute pressure which includes atmospheric pressure Therefore sterilization would require 2 1 bar absolute 2 Gauge pressure is the pressure above atmospheric pressure Theref
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