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Functional Specification

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1. 51 7 Non functional attributes 92 Ta Ayala ias e AA a 52 7 1 1 Reliability 52 PAZ Redundancy 52 7 1 3 Error checking 52 7 1 4 vland by Operation 5 2800 ese AI See ee es 52 7 2 Maintainability 52 7 2 1 Service ACCESS as e ee ee 52 7 2 2 Expansion 4 enhancement possibilities 52 7 2 3 spare capacity ss amp 2 SE SE A A e 52 7 2 4 Likely changes in environment 52 7 2 5 Uifetme 53 7 3 FUNGUON Kiini 6 2 28s Sees a See A A 93 7 4 Factory ACCepiance est gt e Ske es e a Se Se Sie ee 93 L9 Shipping amp Crating 53 7 6 Documentati n e 3202201835305 E E E 93 7 7 Installation 53 7 8 Training 53 NS Qualifications e s owa soer E p Eea eee ee a 53 TAO SENICE S aa isi a AE ai RARA AA AAA 53 B GIOSSA 2 a A AN tS a E 99 gr ETT PES ise 2 a a 2 re a E 96 10 Document istorys gt S LE e a See eS 97 25 GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 1 Introduction Getinge Life Science 1s a division of the Getinge group of companies Group products are used in the pharmaceutical scientific and health
2. 4 7 0 9 The process logging is stopped 3 5 Alarms amp Messages 3 5 1 Failure Alarms 3 5 1 1 If failure alarm occurs 3 5 1 1 1 The process stops when the alarm condition occurs Si Valves and motors are put in a safe condition Sa E E The alarm is highlighted with an audible signal and a visual flashing indication 3 5 1 1 4 A specific alarm text will be printed in the process report 3 5 1 1 5 The last 20 alarms are stored in the control system memory which is possible to access through a user interface 3 5 1 1 6 Interlock alarms shall not stop an ongoing process but prevent start of a new 2s GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 3 5 1 2 31 2 S BR DIN E KE d23 3 5 1 2 6 NS be 3 5 1 2 8 3 5 1 3 Ll o re BZ 3 5 1 3 3 3 5 1 3 4 Gro e IDG IILI 3 5 1 3 8 33139 3 5 1 3 10 3 5 1 3 11 Sd e 12 3 5 1 3 13 3 5 1 3 14 3 3 1 3 15 3 5 1 3 16 3 5 1 3 17 3 5 1 3 18 User reference Version Page Sanofi Synthelabo cd HS 19 60 After a failure alarm The audible signal is muted and the flashing indication changes into a fixed light indication through a button press on the operator interface The program is aborted and taken to a safe ending through a start button press If the authorization key is activated the process can either be restarted through start button or stepped Stepping through critical or potentiall
3. 4 Chamber Bursting Disc 6 5 4 0 1 Manufacturer BS amp B 6 5 4 0 2 Material AISI 316L 6 5 4 0 3 Certification ASME coded UD stamped GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 6 5 4 0 4 Sensor tell tale External pressure switch 6 5 4 0 5 Sensor mounting Between the rupture disk and safety valve 6 5 5 Pressure Switches 6 5 5 0 1 Manufacturer TECSIS 6 5 5 0 2 Type Diaphragm isolated 6 5 5 0 3 Wetted material AISI 316L 6 5 5 0 4 Connector Tri Clover 6 5 6 Sterile Air Filter 6 5 6 0 1 Manufacturer Sartorius 6 5 6 0 2 Type 0 2 micron hydrophobic gas filter 6 5 6 0 3 Filter material PTFE 6 5 6 0 4 Housing material Electro polished AISI 316L stainless steel housing 6 5 7 Automatic In Situ Sterilisation 6 5 7 0 1 Function Automatic in situ filter sterilization All necessary piping and valves will be provided for sterilization and cooling of the filter A pre programmed process will ensure and document that the filter 1s sterilized and ready for use It 1s possible to remove the filter housing 6 5 7 0 2 Process Piping AISI 316L 6 5 7 0 3 Connections before the filter Compression fittings 6 5 7 0 4 Connections after the filter Tri clamp sanitary 6 5 7 0 5 Welding after the filter Automatic tube welded 6 5 8 Automatic integrity test W I T 6 5 8 0 1 Function Automatic in situ testing of the filter s integrity The process
4. 6 IIN 2al The password is not case sensitive 3 9 3 2 8 Access areas give the user access to different areas of the CS1000 and operator interfaces 3 10 Configurative functions and their limits 3 10 1 Adjustable Process Parameters The table s in this section present s the adjustable process parameters and their limits for each process type The process equipment are delivered with default settings in the recipe s of these parameters according to the specified program combination See the program combination in appendix A for fur ther information 3 10 1 1 Vacuum cycle Table 3 mae me Pre Pulse Vacuum 1 99 3 10 1 1 1 Sterilizing Temperature 105 135 C 3 10 1 1 2 25 GE TINGE Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo PA ap 27 60 Table 3 Sterilizing Time 3 minutes 9 hours 3 10 1 1 3 Drying Vacuum Time U minutes 9 hours 3 10 1 1 4 Drying pulses 0 10 3 10 1 1 5 3 10 1 2 Vacuum cycle ramped Table 4 R E Pulse Vacuum 1 99 3 10 1 2 1 Sterilizing Temperature 105 135 C 3 10 1 2 2 Sterilizing Time 3 minutes 9 hours 3 10 1 2 3 Drying vacuum time U minutes 9 hours 3 10 1 2 4 Ramps decrease increase rate 0 1 1 0 bar min 3 10 1 2 5 10 100 kPa min 1 45 14 5 PSI min 3 10 1 3 Ventilator cycle flexible containers Table 5 es CN Sterilizing Temperature
5. 6 1 1 4 Maximum deadleg N A 6 6 1 1 5 Insulation Hot and cold pipes 6 6 1 2 Valve Design 6 6 1 2 1 Valve manufacturer s Gemii ASCO 6 6 1 2 2 Body material Brass 6 6 1 2 3 Gemii valve type Globe piston 6 6 1 2 4 ASCO valve type Solenoid 6 6 1 3 Jacket Safety Valve 6 6 1 3 1 Material Brass 6 6 1 3 2 Regulatory Meets or exceeds the standards for the country of destination 6 6 1 4 Pressure Switches 6 6 1 4 1 Manufacturer Bailey Mackay 6 6 1 4 2 Type Capillary tube 6 6 1 4 3 Wetted material Copper brass bronze de KN Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 6 6 1 4 4 Connector Tri Clover 6 6 2 Door Gasket Piping 6 6 2 1 Pipe Design 6 6 2 1 1 Pipe standard Metric or US O D 6 6 2 1 2 Pipe material Stainless Steel 316L 6 6 2 1 3 Joints Threaded flanged or compression coupling 6 6 2 1 4 Insulation Hot pipes 6 6 2 2 Valve Design 6 6 2 2 1 Manufacturer Gemu 6 6 2 2 2 Body material 316L stainless steel 6 6 2 2 3 Type Globe piston 6 6 2 3 Pressure Switches 6 6 2 3 1 Manufacturer Bailey amp Mackey 6 6 2 3 2 Type Diaphragm copper 6 6 2 3 3 Wetted material Brass 6 6 2 3 4 Connector Threaded 6 6 3 Drain System Piping 6 6 3 1 Pipe Design 6 6 3 1 1 Pipe standard Metric 6 6 3 1 2 Material Copper Brass Bronze 6 6 3 1 3 Joints Threaded or flanged 6 6 3 1 4 Insulation Hot and cold pipes 6 6 3 2 Valve Design 6 6 3 2 1 Manufacturer Gemii 6 6 3 2 2
6. Company and the User Manuals are provided in English Installation A general pre installation instruction is sent to the user prior to delivery to aid the site preparation The apparatus is shipped fully tested and ready for installation Drawings and technical data sheets are provided for specifics of the apparatus installation A customized installation manual and operating instructions are also provided with the apparatus The responsibility for and extent of included work during installation is specified in the contract be tween the Getinge Sales Company and the User Training Included training activities are specified in the contract between the Getinge Sales Company and the User Qualification Included qualification activities are specified in the contract between the Getinge Sales Company and the User Service 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page Included service activities are specified in the contract between the Getinge Sales Company and the User 25 GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 8 Glossary PACS Programmable Autoclave Control System GMP Good Manufacturing Practice cGMP Current Good Manufacturing Practice GAMP Good Automated Manufacturing Practice QMS Getinge Quality Management System GE TINGE Rev B Document type Syst
7. E 46 6 5 2 Valve Design A6 6 5 3 Chamber Safety Valve 46 6 5 4 Chamber Bursting Disc 46 6 5 5 Pressure TG TD As WAA hea AA AA Aa 47 6 5 6 Sterile Ar Fillet 2222 aS chee ae amp Svar Se SS oe oe edd a A7 6 5 7 Automatic In Situ Sterilisation 47 6 5 8 Automatic integrity test W I T 47 6 5 9 Process Pressure Indicator Control Side 47 6 6 Non Process Piping 48 6 6 1 Jacket Piping 48 6 6 2 Door Gasket Piping 49 6 6 3 Drain System Piping 49 6 6 4 PHEUMATIC SISEMI E Eb eh 209 pon A EE 50 6 6 5 Non Process Pressure Indicators 50 6 Electrical System 50 6 7 1 Voltage amp Frequency Requirements 50 6 7 2 Grounding amp Connections 50 6 7 3 Wiring 50 6 7 4 Components 50 6 7 5 Conduits eee eee ee ee eee 51 6 7 6 Enclosures gt 162 a e A A A Se E 51 6 8 Customized alarm se na Bos da e e e wae 51 25 GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 6 8 1 High level alarm 51 6 8 2 Proximity switch
8. Order reference Document No Functional Specification User User reference Version Page The jacket heating may be adjusted to operate when a process 1s not active The function provides an easy up process start The availability requires some steam and gives residual heat 3 10 2 1 1 The jacket heating is activated through a soft switch in the system program 3 10 2 1 2 The jacket temperature is targeting 100 C when jacket heating is on during idling 3 10 2 1 3 Jacket heating will always be off when programs that not require heating are chosen 3 10 2 2 Steam generator monitoring 3 10 2 2 1 The equipment is prepared for steam generator monitoring A dedicated digital input 1s monitored and it is supplied with a jumper at delivery The equipment must be provided with a cable connection to the steam generator in order to utilize the function 3 10 2 2 2 An open circuit indicate steam generator malfunction refer to PROCESS ALARMS Failure alarm list 3 10 2 3 Low speed printout interval 3 10 2 3 1 Is by default 1 minute and maybe configured within the range 1 second 99 minutes Refer to Configu ration ACCESS RESTRICTIONS 3 10 23 2 A value faster than the process printer capacity maybe selected but not executed 3 10 2 4 High speed printout interval 3 10 2 4 1 Is by default 30 seconds and maybe configured within the range 1 second 99 minutes Refer to Config uration ACCESS RESTRICTIONS 3 10 2 4 2 A value faster than the pr
9. Rationale for classification In order to judge how to classify individual requirements Getinge Sterilization AB is using a GMP Im pact Assessment Rationale 3 The rationale is available for user audit at Getinge Sterilization AB 2 1 3 4 Ready off the shelf components qualified in development projects Some hardware and software components are qualified in development projects and are then main tained in a validated state The components are subject to project change control when they are maintained and updated Qualified components are normally not subject to testing and verification in this specific project Referenced qualified components in the specification which is used in this project are available for user audit from this description The associated qualification activities in a development projects varies refer to the Getinge Validation Policy 6 for a definition 2 1 4 Important Issues during and after delivery The listed activities issues are covered in the NON FUNCTIONAL ATTRIBUTES section Maintainability Service Testing and Qualification Shipping Documentation Installation Training 2 2 Reference to GxP regulations and other directives 2 2 1 Guidelines The project is performed in accordance with ISPE GAMP4 ISPE Baseline FDA General principles of software validation Final guidance 2002 2 2 2 GxP regulations FDA 21 CFR Part 211 Finished Pharmaceuticals FDA 21 CFR Part 210 General 2
10. The passwords menu provides functions for maintenance of users passwords and area access for each user The menu also provides support descriptions of the area access codes All functions requires J area access 5 3 3 2 20 The dipswitches menu provides enabling or disabling of soft switches affecting the behaviour of the application software e g whether media switches should be monitored or not All functions requires F area access S A The service menu provides access to the error log the diagnostic and the PACS addresses menus The function requires E area access xe e 22 The error log menu provides functions for viewing and printing the last 20 alarm list The function requires E area access 5 3 3 2 23 The diagnostic menu provides access to the analog input the analog output the digital in put the digital output the system flag the user flag the printer and the led buzzer menus The function requires E area access 5 3 3 2 24 The analog input menu provides viewing of the analog input values The function is accessible through the menus service diagnostics and requires E area access O e A The analog output menu provides viewing and manual control of the analog outputs The function is accessible through the menus service diagnostics and requires E area access 03 220 The digital input menu provides viewing of t
11. cycle graph simultaneously on the same page A thirty two 32 column thermal Cobex printer is provided with the apparatus to document the proc ess It is mounted into the fascia of the apparatus Process documentation logging includes a header that contains the date and time of the process selected process start process parameter values batch information and the machine counter number of processes started Process phase changes are logged with the name of the event along with a log of process data A printing log rate determines the duration between logging samples during the start and the completion of a process System alarms are printed during the process with the alarm name and a single log of data A signature line is provided for a su pervisor or operator signature The control system including operator controls instruments report process and alarm features is de scribed in accordance with the GAMP guideline in the FUNCTIONS DATA and INTERFACES sec tions Mechanical system The mechanical system covers the mechanical enclosure pressure vessel piping electrical system and loading equipment if included Mechanical Enclosure Stainless steel fascia panels are provided to separate the apparatus from the operator areas and make cleaning easy The endurable fascia panels surrounds the apparatus in a so called cabinet The fascia panels are supported by a stainless frame structure Certain selected fascia panels are hinged and
12. for items such as normal utensils and non liquid components rubber stoppers and non liquid com ponents or equivalent applications The included post pulsing improves drying of components that is difficult to dry or components with particular need for final dryness 3 4 1 0 1 Jacket heating is on through the entire program 3 4 1 0 2 The process logging 1s started 3 4 1 0 3 Air is removed in the chamber atmosphere and load through repeated evacuation and steam injection to a pressure just above atmospheric The fan starts and runs in low speed mode The dilution continues for an adjustable number of pulses 3 4 1 0 4 Steam is injected and condenses removed in order to heat up the chamber atmosphere and load to ho mogeneous sterilization temperature The process continues to sterilization when all sensors have met sterile temperature 3 4 1 0 5 Physical sterilization is controlled at a selected hold temperature for a pre determined time 3 4 1 0 6 Load drying is performed at a pressure below 0 1 bar a 10 kPa a 1 45 PSIA through evacuation The drying shall continue for an adjustable time 3 4 1 0 7 Admit air in the chamber and evacuate repeatedly for an adjustable number of pulses 3 4 1 0 8 The fan is stopped The chamber pressure is adjusted close to atmospheric 3 4 1 0 9 The process logging 1s stopped 3 4 1 0 10 The sterilizer is ready for opening of the door s 3 4 2 Vacuum cycle ramped The process 1s intended for steam steri
13. in a process exceeds a reasonable maximal time Door Interlock is set if a hard wire door switch has a status other than expected Door Seal Interlock is set if a hard wire door seal pressure switch has a status other than expected Pressure Interlock is set if a hard wire chamber pressure switch has a status other than expected Temperature Interlock is set if an independent load temperature interlock relay has a status other than expected Vacuum Pump Failure the alarm is set if the vacuum pump is not working Fan Failure Alarm the alarm is set if the fan is not working Fan Seal Alarm the alarm is set if the fan seal is leaking Low Temperature the control temperature is lower than the sterile temperature set point during steri lization GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 3 5 1 3 19 3 5 1 3 20 35 13 21 K e SI PAS 3 5 1 3 24 3 5 2 3 5 2 1 RN del Liz 3 5 2 1 3 3 5 2 1 4 39 2155 3 5 2 1 6 pS E 3 5 2 2 3322 SISI MDA Sa WANI 3 32 24 3 5 2 3 E E 2 Fo No re 3 5 3 3 5 3 1 renee la User reference Version Page Sanofi Synthelabo alanad B 20 60 High Temperature the controller input temp is higher than sterile temperature set point 3 in sterile or 4 in kill Jacket Temperature High the jacket has exceeded sterilization temperature 4 during process High Pressure the ac
14. input and output capacity provided 7 2 4 Likely changes in environment No arrangements for environmental changes are provided GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 7 2 5 Lifetime 12 30 The equipment is designed for normal operation during at least 10 years 725 0 2 Normal operation is defined as 8 hours a day during 220 days per year 7 3 7 4 7 0 7 5 0 0 1 7 5 0 0 2 7 6 7 6 0 0 1 7 6 0 0 2 1 1 7 7 0 0 1 7 7 0 0 2 7 7 0 0 3 7 7 0 0 4 7 7 0 0 5 7 8 7 9 7 10 Functional Testing Functional testing is always included and is ruled through procedures in the Getinge QMS 4 Factory Acceptance Test Included acceptance test activities are specified in the contract between the Getinge Sales Company and the User Shipping amp Crating Preparing the equipment for shipment and crating will be completed at the factory in Sweden Getinge has a long history of shipping equipment globally and will pack and crate the equipment so that it will arrive safely at your facility Depending on the agreed shipment methods will one of the following packages be used Ground or air The equipment will be hedged Sea The equipment will be crated and water protected with a plastic cover Documentation Included documentation and number of copies for e g manuals drawings and test reports are specified in the contract between the Getinge Sales
15. numbers will be documented on the electrical schematics All terminal blocks are clearly marked 6 7 3 0 2 Color standard NFPA 14 2 4 6 7 4 Components 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 6 7 4 0 1 Motor starter manufacturer Telemechanique 6 7 4 0 2 Power disconnect manufacturer Telemechanique 6 7 4 0 3 Circuit breaker manufacturer ABB 6 7 5 Conduits 6 7 5 0 1 Type Open wire ways 6 7 5 0 2 Material Plastic 6 7 6 Enclosures 6 7 6 0 1 Enclosure material Painted steel 6 7 6 0 2 Rating Min IP 55 NEMA 12 6 7 6 0 3 Manufacturer Rittal or NPP 6 7 6 0 4 Service Clearance Forward 1 m 3 1 2 ft 6 7 6 0 5 Internal light Included 6 7 6 0 6 External Power Outlet European Standard Included 6 7 6 0 7 PC connection 9 pin D Sub 6 7 6 0 8 Authorization Key Side mounted 6 8 Customized alarm 6 8 1 High level alarm 6 8 1 0 1 Getinge will add an extra alarm for high level off external tank Tank is delivered by customer 6 8 2 Proximity switch 6 8 2 0 1 Getinge will add an extra alarm for external tank in position Sensor 19 provided by customer GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo alanad E 55 60 T 1 1 Non functional attributes Availability PAR Reliability 7 1 1 0 1 Service interva
16. snap secured for service access to the apparatus All instruments are positioned to provide easy access and visibility for the operator 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page NOTE The sketch below is generic and used for improved understanding The exact configuration may be different refer to relevant sections for valid data regarding chamber dimension user interfaces and indicators O O Coco 0000 O 2 3 3 2 Pressure Vessel The pressure vessel is a welded and internally grounded chamber of high grade stainless steel with ports for media drains sensors and validation equipment Robotic manufacturing eliminates defects associated with manual techniques and provides an extremely high level of consistency The pressure vessel has a jacket and automatic horizontal door assembly ies The jacket enables functionality for steam heating The heating reduces the process steam demand of the chamber while in process thereby producing a more efficient and effective process The heated jacket will also reduce the amount of condensate formed within the chamber Construction of the door s consist of stainless steel plate reinforced on the external surface and is held in place during operation by retainers welded to the pressure vessel The door
17. with water which then cools the fan distributed air The heat energy is removed from the load by the forced airflow The pres sure will decrease during the cooling and hence must the support pressure be reduced simultaneously to protect the load 3 4 3 0 5 The chamber pressure is adjusted close to atmospheric 3 4 3 0 6 The process logging is stopped 3 4 3 0 7 The sterilizer is ready for opening of the door s 3 4 4 Ventilator cycle rigid containers GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page The process 1s intended for steam sterilization of liquid in sealed glass or rigid containers The contain ers must be possible to keep intact by supporting their internal pressure with an elevated chamber pres sure 3 4 4 0 1 The process logging 1s started 3 4 4 0 2 Steam is injected into the chamber from the top and the chamber drain is opened to remove air and con densate The ventilator fan starts and runs in low speed mode When the temperature reach a pre deter mined limit the support pressure is started and the chamber drain closes Though the chamber drain bypass is still open The process continues to sterilization when all sensors are above sterile tempera ture or if sufficient FO value is attained at all load sensors 3 4 4 0 3 Physical sterilization is controlled at a selected hold temperature for a pre determined time or if desired FO value
18. 0 3 Inaccuracy less than 1 of actual value in range 1 5 bar a 100 500 kPa a 14 5 72 PSIA 3 8 3 0 4 Pressure resolution and inaccuracy also applies to PACS Supervisor 3 8 4 Timer accuracy 3 8 4 0 1 Timer inaccuracy 1s less than 10 seconds per 3 hours approximately 1 1000 3 8 4 0 2 Timer inaccuracy also applies to PACS Supervisor 3 9 Safety and security 3 9 1 Operator safety 3 9 1 1 Emergency Stop 3 91 11 An emergency stop button with an associated signal to the control system and an independent hard wire circuit to media supply valves is provided Refer to INTERFACE section for a description 3 9 1 2 Media to Chamber Interlock 3 9 1 2 1 A door locked switch signal to the control system and an independent hard wire circuit to the supply valves is provided Supply media can not enter the chamber unless the door is closed amp locked 2s GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 3 9 12 2 A door seal pressure signal to the control system and an independent hard wire circuit to the supply valves is provided Supply media can not enter the chamber unless the door seal pressure is applied 3 9 1 2 3 An emergency stop signal to the control system and an independent hard wire circuit to supply valves are provided Supply media can not enter the chamber when the emergency stop is activated 3 9 1 3 Door Opening Interlock 3 9 1 3 1 An emergency
19. 105 124 C 3 10 1 3 1 Sterilizing Time 3 minutes 9 hours 3 10 1 3 2 Support Pressure 0 1 5 bar a 3 10 1 3 3 0 150 kPa a 0 21 8 PSIA Cooling Pressure 1 3 5 bar a 3 10 1 3 4 100 350 kPa a 14 5 50 8 PSIA Cooling Temperature 20 80 C 3 10 1 3 5 3 10 1 4 Ventilator cycle rigid containers Table 6 a CI wde dx GETINGE Rev B Document type System Order reference Document No User User reference Version Page Table 6 a PIAR Temperature 105 124 C Pre 10 1 4 1 nd Temperature 0 4 C 3 10 1 4 2 Sterilizing Time 3 minutes 9 hours 3 10 1 4 3 Support Pressure 0 1 5 bar a 3 10 1 4 4 0 150 kPa a 0 21 8 PSIA Cooling Pressure 1 3 5 bar a 3 10 1 4 5 100 350 kPa a 14 5 50 8 PSIA Cooling Temperature 20 80 C 3 10 1 4 6 3 10 1 5 Leak rate test cold Table 7 IN CI Max accepted leak rate 0 013 bar a 10 min 3 10 1 5 1 1 3 kPa a 10 min 0 19 PSIA 10 min 3 10 1 6 Maintenance program for in situ air filter sterilization SIP Table 8 m CI Sterilizing Temperature 105 135 C 3 10 1 6 1 Sterilizing Time 3 minutes 9 hours 3 10 1 6 2 3 10 1 7 Maintenance program for in situ air filter integrity test WIT Table 9 Ll Time 10 minutes 3 10 1 7 1 Drying Time 3 minutes 9 hours 3 10 1 7 2 3 10 2 System Configuration 3 10 2 1 Activated jacket heating 25 GE TINGE Rev B Document type System
20. 22 Application software backup into a PROM on the main board is made through an operating panel or programming tool 3 92 23 Application software recovery is performed from PROM or through a backup file with the program ming tool to the main board RAM 3 9 2 2 4 When application software recovery is performed from a PROM it requires a cold start of the system 9225 Application software recovery the manufacturer Getinge keeps a copy of the application software as delivered 3 9 2 2 6 System software backup the control system operating system is executed directly in the system PROM s and will thus not be lost due to power failure or similar causes 39 2AT System software backup the control system has no facilities for system software backup 3 9 2 2 8 System software recovery if the system fails for any reason Getinge can provide replacement PROM s which when they are installed recovers the system 3 9 2 3 Disaster recovery 3 9 2 3 1 If power and backup battery failure happens simultaneously is the application software in RAM lost 392 332 Recovery is performed according to Application software recovery above 3 9 2 3 3 Note Calibrations and changes to the application software performed after the application software was backed up are lost 3 9 2 3 4 System software Getinge can provide replacement Prom s which when they are installed recovers the system 3 9 3 System security 3 9 3 1 Input Value Checking Adjustable process parameters are
21. 4 2 All included switching interlock contacts shall monitor in their both positions to assure working non glued contacts Some of those checkpoints may be a part of the normal operating sequence The others are separately monitored to reveal a failed contact status that otherwise had remained undetected Refer to process alarms for included interlock alarms 3 9 1 5 Redundancy 3 9 1 5 1 The control system and a hard wired independent system control the door interlock refer to MEDIA TO CHAMBER INTERLOCK and DOOR OPENING INTERLOCK above for a description of the safety system 3 9 2 Data integrity 3 9 2 1 Power failure 3 9 2 1 1 The control system RAM memory has battery backup so data will not be lost during power failure 3 9 21 2 A battery with low voltage will be indicated with an information alarm refer to PROCESS ALARMS information alarms 3 9 2 1 3 A power failure exceeding 10 seconds will result in a failure alarm when the power returns 3 9 2 1 4 A power failure less than 10 seconds will continue the process when the power returns 25 GE TINGE Rev B Document type Functional Specification System Order reference Document No V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo Malvern Pet Ronovanons E Z 25 60 3 9 2 1 5 The doors remain closed and locked during power failures 3 9 2 2 Backup and recovery 3922 1 Application software backup to file requires a PC with a Getinge programming tool 592
22. 5 3 3 1 Steam Generator Error prevents start and is shown during 5 seconds E Step Key Is On prevents start and is shown during 5 seconds 3 5 3 3 3 Printer Active a printing process printer prevents start for 15 minutes and is shown during 5 seconds 3 5 3 3 4 Active Alarms still active alarms prevents start and is shown during 5 seconds i es Fs ES Door Seal Pressure faulty status prevents start and is shown during 5 seconds 3 5 3 3 6 Door not closed prevents start and is shown during 5 seconds a o Door Key Switch a door interlocked for closing prevents start and is shown during 5 seconds 3 53 38 Jacket Temp Low If the jacket temperature is too low compared with the jacket control temperature 3 5 3 3 9 Jacket Temp High If the jacket temperature is too high compared with the jacket control temperature 3 5 3 3 10 Bursting Disc If the bursting disc is leaking or broken 3 5 3 4 Specific features for Service messages 3 5 3 4 1 The messages are constantly active in standby when the condition is active 3 5 3 4 2 The messages do not prohibit the start of a process 3 5 3 5 List of Service messages 3 5 3 5 1 Battery Error is always on when the conditions occurs does not affect the process at all Sh EE Manual Outputs is always on when a DO or AO is manually set and does not affect the process 3 5 3 6 Specific features for Process report messages 3 5 3 6 1 The messages are only recorded on the process report 3 5 3 7 List of Proce
23. 5 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 2 2 3 Directives amp Regulations Underwriters Laboratories UL Factory Mutual FM and Electrical Testing Laboratories ETL are independent test institutes NRTL 9 in USA and testing products regarding personal safety Their equivalence in Sweden is ETL SEMKO The equipment is ETL labeled designed manufactured and tested for compliance with 2 2 3 1 Safety standards The marking ETLc for Canada means compliance to e CAN CSA STD C22 2 No 1010 1 The marking ETLu for USA means compliance to UL IEC Harmonized Standard for safety e UL 61010 1 Electrical Equipment For Laboratory Use Part 1 General Requirements B e UL 61010 2 041 Electrical Equipment for Laboratory Use Part 2 Particular Requirements for Auto claves Using Steam for the Treatment of Medical Materials and for Laboratory Processes B e UL 61010 2 042 Electrical Equipment for Laboratory Use Part 2 Particular Requirements for Auto claves and Sterilizers Using Toxic Gas for the Treatment of Medical Materials and for Laboratory Processes C 2 2 3 2 Electrical Codes NFPA 70 National Electrical Code NEC in applicable parts e g article 670 etc NFPA 79 Electrical Standards for Industrial Machinery 2 2 3 3 Pressure Vessel Code American Society of Mechanical Engineers ASME New York AS
24. Body material Brass Bronze 6 6 3 2 3 Type Globe Piston 6 6 3 3 Pump Specification 6 6 3 3 1 Manufacturer SIHI 6 6 3 3 2 Type Liquid ring pump 6 6 3 3 3 Case material Cast ron 6 6 3 3 4 Impeller material Brass 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 6 6 3 3 5 Capacity Chamber dry air evacuation to 0 4 Bars a 6 PSIA in less than 60 seconds 6 6 3 4 Cooling Condensor 6 6 3 4 1 Manufacturer Cetetherm 6 6 3 4 2 Type Plate heat exchanger 6 6 3 4 3 Material Stainless steel plates brazed with copper 6 6 4 Pneumatic System Piping 6 6 4 0 1 Tube standard Metric 6 6 4 0 2 Tube material Plastic Polyurethane C98A 6 6 4 0 3 Connection Rapid fittings or compression couplings 6 6 5 Non Process Pressure Indicators 6 6 5 1 Jacket Pressure Indicator Control Side 6 6 5 1 1 Manufacturer WIKA 6 6 5 1 2 Type Bourdon tube 6 6 5 1 3 Material Copper Brass 6 6 5 1 4 Scale 1 5 Barg 0 30 inchHg 0 45 PSIG 6 6 5 1 5 Connection Threaded 6 7 Electrical System 6 7 1 Voltage amp Frequency Requirements 6 7 1 0 1 Voltage 460 Volts 6 7 1 0 2 Phases 3 6 7 1 0 3 Frequency 60 Hertz 6 7 2 Grounding 8 Connections 6 7 2 0 1 Connection wires necessary 4 3 phases and a ground wire 6 7 2 0 2 Compatible to system type TN S TN C or IT system 6 7 3 Wiring 6 7 3 0 1 Markers Wires are marked using non smearing heat resistant markers Wire
25. CE ERROR LOG DIAGNOSTIC ANALOG INPUT ANALOG OUTPUT DIGITAL INPUT DIGITAL OUTPUT SYSTEM FLAG USER FLAG PRINTER LEDS BUZZER PACS ADDRESSES SAVE RAM TO FLASH All system functionality requires specific area access SE reo A The time settings menu provides access to the calendar and the alarm clock menus The func tion requires B area access K E PO The calendar menu provides updating of time amp dates The function requires B area access 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page o ie ato UR The alarm clock menu displays if there is one a list of events that can be started automatically at times set here The function requires B area access 5 3 3 2 4 The calibration menu provides access to the manual calibration the automatic calibration and the bridge tables menus The function requires C area access 33 572 The manual calibration menu provides features for manual adjustment of the constants GAIN and OFFSET that is used for correction of analogue input signals A calibration report may be directed to the process printer for documentation All functions require C area access ZO The automatic calibration menu provides features for automatic adjustment of the constants GAIN and OFFSET that is used for correction of analogue input signals A calibration report may b
26. Document type Functional Specification User Sanofi Synthelabo Getinge Signatories Prepared by Full name Stefan Nilsson Reviewed by Full name Henrik Ek Getinge approval Full name Joakim Bergius Pharma Signatories User approval Full name User approval Full name User approval Full name Order reference V30259 5101874 User reference Version Malvern PA Renovations B System Functional Specification Title Signature Date Title Signature Date Title Signature Date Regional Sales Manager PEA i T 7 7 T 25 GE TINGE Document No T1705 1 60 Rev B Document type System Order reference Document No User User reference Version Page li JAGMOGUCION 2 Ra ee AE 3 1 1 This Functional Specification 3 1 1 1 Who made this document 3 1 1 2 Authority 3 1 1 3 PUTOS S SE A at tes Sree eee Ree Be Sue ele E 3 1 2 Contractual StaluS Sse i ae Ry Se E ey L 3 2 Overview 4 2 1 Key objectives and benefits 4 2 1 1 Confidence 4 2 1 2 The Sterilizer Objective 4 2 1 3 GMP Impact 4 2 1 4 Important issues during and after delivery 5 2 2 Reference to GxP regulations and other directives 9 2 2 1
27. Guidelines 5 2 2 2 GxP regulations 5 2 2 3 Directives Regulations 6 2 2 4 Quality Certification 6 2 3 High level description 6 2 3 1 GMP Features 22229853092 WA a je 6 2 3 2 Control system PACS 3000 6 2 3 3 Mechanical system 2 Se SS ere eee ere ees 7 2 3 4 Eleclical SYSte Sat ee irse A ee RA 9 2 4 Main interfaces from the system to other systems or the environment 9 2 4 1 Control system interfaces 10 2 4 2 Mechanical system interfaces 10 2 5 ASSUIMPUOMS 5 5 323225 Bite E E AAA A E 10 6 FUNCIONS o me Se ee 11 3 1 Door functions 11 3 2 Process Program Selection 11 3 3 PROCESS Slat 22 Se Se a Se ee A ee oe 11 3 4 Process Program Combination V3110 11 3 4 1 Vacuumcycle 12 3 4 2 Vacuum cycle ramped 2 see be eee Se SS Se ee 12 3 4 3 Ventilator cycle flexible containers 13 3 4 4 Ventilator cycle rigid containers 13 3 4 5 Leak fale TeS Cold Sas AAA See e ee 14 3 4 6 Program for in situ air filter sterilization Sterilization in place SIP 14 3 4 7 Program for in situ air filter integrity test Water Intrusion Test WIT 15 3 5 Alar
28. H4SMEER PRESS The OP30 user interface consists of a 320x240 color LCD and a membrane keyboard with integrated LED s Refer to the development project with URS 565 15 53 issue J and HDS 565 15 55 for more information The referred documents are available for audit at Getinge Sterilization AB Sweden 5 3 1 Description of buttons and LED s 5 3 1 0 1 The keyboard is provided with five soft key buttons located below the display The soft key function available in a certain menu for a button will be described by a text on screen 5 3 1 0 2 The keyboard is provided with four navigator buttons The buttons will be used for selection in drop down menus and alphanumerical palettes available on screen 5 3 103 The keyboard is provided with an enter button e g used for choice of a selected menu function in a list 5 3 1 0 4 A button is provided for door opening 5 3 1 0 5 A button is provided for door closing 5 3 1 0 6 A button is provided for alarm mute and alarm reset The button is also used for program stepping The stepping function is only available during process when the authorization key is activated 5 3 1 0 7 A button is provided for process start 5 3 1 0 8 A yellow LED indication is provided for closed doors 5 3 1 0 9 A yellow LED indication is provided for closed and locked doors 5 3 1 0 10 A yellow LED indication is provided for a process cycle in progress 5 3 1 0 11 A multicolor LED indication is provided for a co
29. Heat Exchanger for Cooling Material Location Fitted Cooling media AISI 316Ti stainless steel tube corresponding to Wnr 1 4571 Inside the chamber between the chamber wall and inner liner Continuos stainless steel tube which is passed through a chamber port and sealed on the external side of the tube This prevents any cross contamination of cooling media and the chamber environment Cooling water Chamber Insulation amp Cladding Material Cladding material Cladding thickness Cladding texture Cladding assembly Steam supply Non corrosive glass wool fulfilling requirements in ASTM 795 Aluminum sheet metal 1 5 mm 0 06 Stucco The aluminum sheets are joined together around the chamber with all openings capped to prevent shedding of the insulation material Clean steam generator Type Heat exchanger Material Steam heated Double tube plate AISI 316L Feed water pump material 6 3 1 1 4 6 3 1 2 6 3 1 2 1 6 4 6 4 0 0 1 6 4 0 0 2 6 4 0 0 3 6 4 0 0 4 Casing Wnr 1 4581 Stainless steel Wheel Wnr 1 4571 Stainless steel Sealing SiC A Carbon Viton Feed water isolation valve Gemu diaphragm Clean steam generator size Maximum steam output 200 lbs hr Media Connections Common Steam External Steam Supply Process Air External Air Supply Instrument Air External Air Supply Pump water External Water Supply 2s GE TINGE Rev B Document type System Order reference Documen
30. ME Code Section VIII Div 1 and Section I Remark The pressure testing is audited by a notified body for regulatory compliance 2 2 4 Quality Certification Getinge Sterilization is qualified and works according to ISO 9000 2000 2 3 High level description The Sterilizer is an integrated system that consists of the pressure vessel piping system frame fascia and a control system a PLC with instruments and operator interfaces This description contains gen eral features and subsections for Control System Mechanical System and Electrical System 2 3 1 GMP Features Getinge has incorporated features in the sterilizer to meet or exceed current Good Manufacturing Prac tices CGMP The features provide even temperature distribution once stabilization is achieved Sec ondary temperature verification is furnished by including one additional temperature sensor located in close proximity to the drain temperature sensor Digital read out of the secondary temperature sensor is provided to the operator A condensate level sensor is installed down stream from the drain temper ature sensor This ensures that the drain line temperature sensor is unaffected and that condensate does not come into contact with the product being sterilized The process wetted indicators described above conform to cGMP standards for hygiene accuracy scale and readability Process piping is designed and constructed to minimize dead legs A chamber port is provided to accommod
31. ade linear and fil tered and calibrated The values are stored in the I O database part of the CPU RAM Analogue output The analogue output values are stored in the I O database part of the CPU RAM The system and ap plication software updates the values in the I O database upon execution in the processor Program data GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page The system software resides in the system prom and the application software resides in the program database part of the CPU RAM The processor executes the software and 1s constantly reading and writ ing data in the RAM databases 4 1 3 Operator Panel data Operating panels and program tools are communicating with the control system through serial interfac es Data 1s both received and transmitted between the operator interface and the control system 4 1 4 The PACS control system software reads the process values in the RAM and formats it to text strings The text strings 1s transferred to the process printer over a RS232 serial interface Super visor data The Supervisor reads and calls for process values through a RS232 serial interface The Supervisor has no access to internal data in the control system Refer to the INTERFACE section for a more detailed description 4 1 5 Process report data The Supervisor system software reads the process values in the RAM and formats it to tex
32. al users The OP30 provides independent indicators for cycle status door status availability of steam and alarm status at all times Direct access keys for the most commonly chosen processes are provided as well as arrow keys for full navigation of the data tree A start button is provided to initiate the process Open and close door buttons are provided to operate the control side door The button portion of the control panel is completely sealed to allow for easy cleaning Audible and visual indicated alarms are provided to detect unexpected or critical situations A failed process will be highlighted on the process report through a specific text when the situation occurs the process will be labeled with PROCESS FAILURE in the end of the report The PACS Supervisor is a separate system for process monitoring that replaces an independent record er and produces on a single page in real time both the apparatus data and the data from it s independent sensors This eliminates the arduous task of analyzing the apparatus data and the independent recording device by operating personnel after the process has ended Process data is captured and stored within the PACS Supervisor controller and can be repeatedly printed out until the start of the next process This emergency printout is most commonly used when a printer has failed 1 e paper jam or empty cartridge Additional printing modes are available such as printing the logged data and the
33. ata 27 4 1 PACS3000 data flow general layout 27 4 1 1 Odata 27 4 1 2 Program data 27 4 1 3 Operator Panel datas 232 Sake a a e St ee Bee 28 4 1 4 The PACS control system software reads the process values in the RAM and formats it to text strings The text strings is transferred to the process printer over a RS232 serial interfaceSupervisor data 28 4 1 5 Process report data 28 9 NICK ACES e e e R ee Shree es ee AA 29 5 1 Control Side Operator Switches 29 5 1 1 Switch description 29 5 2 Control side operator switches second row 30 5 2 1 Switch description 30 5 3 User internace OP30 223 eke ek See A AA 3i 5 3 1 Description of buttons and LED s 31 5 32 Definition of user roles 32 5 3 3 Functions available 32 5 3 4 Error handling and security 36 5 4 Interface with equipment 37 5 4 1 Temperature sensors 3 9 4 2 PICSSULC SCNISOLS sa gt See ae ES ee A ee A 37 5 5 The PACS SUPernisor Spid ds ee Ste ri Se Se A Wa 38 5 6 Report interface Cobex thermal printer 39 SS GE TINGE KN Rev B Document type System Order reference Document No User User re
34. ate temperature sen sors for validation 2 3 2 Control system PACS 3000 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User Sanofi Synth elabo Malvern PA Renovations B 2 3 3 2 3 3 1 User reference Version 10 60 The PACS 3000 programmable logic control system was designed built and tested according to the GAMP guideline and ISO 9001 quality system The PACS 3000 system includes all aspects of control accuracy reproducibility documentation analysis monitoring multi level password security alarm ing programming maintenance and human machine interface of the apparatus data and processes It is a modular system and comprises sufficient I O for the chosen process An on off power switch an emergency stop push button a door blockage key and a user interface panel are provided on the control side of the sterilizer The user interface panel is a OP30 5 7 color screen which provides the display of current cycle se lection remaining cycle time current phase name of the process trend graph of the process real time data parameter settings and maintenance functions Process selection process parameters operator names and other necessary alphanumeric information can be entered via the OP30 panel The OP30 operator interface has supervisor operator and maintenance functions with password pro tection profiles for individu
35. ber pressure is adjusted close to atmospheric The pressure change rate is controlled not to exceed an adjustable value 3 4 2 0 8 The process logging 1s stopped 3 4 2 0 9 The sterilizer is ready for opening of the door s 3 4 3 Ventilator cycle flexible containers The process 1s intended for steam sterilization of liquid in sealed plastic or flexible containers The con tainers must be possible to keep intact by supporting their internal pressure with an elevated chamber pressure The support pressure is controlled to support the internal pressure changes in the products to protect the load 3 4 3 0 1 The process logging 1s started 3 4 3 0 2 Steam 1s injected into the chamber from the top and the chamber drain is opened to remove air and con densate The ventilator fan starts and runs in low speed mode When the temperature reach a pre deter mined limit the support pressure is started and the chamber drain closes Though the chamber drain bypass 1s still open The process continues to sterilization when all sensors are above sterile tempera ture or if sufficient FO value is attained at all load sensors 3 4 3 0 3 Physical sterilization is controlled at a selected hold temperature for a pre determined time or if desired FO value is attained at all load sensors 3 4 3 0 4 The fan is not used during the first part of the cooling when the steam atmosphere collapses After a few minutes the ventilator fan starts The internal heat exchangers is cooled
36. care industries in over 120 countries spanning five continents Getinge Life Science manufactures industry standard and custom designed sterilization equipment in its modern facility in Getinge Sweden Our production facilities are available for inspection at any stage of a project In particular we recommend visits during initial discussions and witnessing final testing at our facility 1 1 This Functional Specification 1 1 1 Who made this document A representative at Getinge Sterilization makes this document The specification will formally be han dled and revised by the regional sales manager 1 1 2 Authority The responsibility for this Functional Specification and the content is at e Getinge Sterilization AB when the order is accepted by the manufacturer Any kind of questions or viewpoints about the content shall be appealed to those authorities 1 1 3 Purpose The Functional Specification is made in order to describe the functions to meet the user requirements This document is divided into major sections The first section OVERVIEW is a general description of the objectives and the equipment being offered The following sections presents specific facts on the design and functions of the equipment It is intended for design qualification and to answer more detailed questions that are often raised by engineers as well as operating and service personnel A table of contents is provided for quick access to the information c
37. ccess NOTE Area D access will be prompted during execution of programs or process functions with pin code protection Texts and menus are provided in English The set up drop down menu give access to the details the plot graph the bar graph the print last cycle the system and the about menus described below The details screen shows a scrollable list containing the displayable parameters This menu is showed after a cold start and is also accessible through the setup drop down menu The plot graph screen shows a graph of two predefined parameters as growing curves This menu is accessed through the setup drop down menu The har graph screen shows two predefined parameters as vertical bars This menu is accessed through the setup drop down menu The print last cycle menu reprints the last process report The option is only available when no proc ess is ongoing This menu is accessed through the setup drop down menu GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User S de M Er 5 3 3 1 8 s e 5 3 3 1 10 S e EN 5 3 3 2 User reference Version Page Sanofi Synthelabo Malvern Pe Ronovanons B 36 60 The system menu provides access to the system menu tree refer to System functions Any of the area passwords B C E F G H J amp K is valid for access to
38. ce Anodized 6 1 2 2 3 Color NCS S 4550 R80B Dark Blue 6 1 2 3 Instrument Sections 6 1 2 3 1 Material Extruded aluminum profile 6 1 2 3 2 Surface Powder Coated Polyester Paint 6 1 2 3 3 Color NCS S 2060 R80B Light Blue 6 1 3 Piping Skid 6 1 3 0 1 Design Rectangular profile 6 1 3 0 2 Material Stainless steel 1 4301 304 6 1 3 0 3 Surface finish Mechanically polished 6 1 3 0 4 Feet Adjustable threaded 6 2 Pressure Vessel 6 2 1 Chamber Configuration 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 6 2 1 0 1 Loading Height Loading Height 600 mm 24 6 2 2 Installation 6 2 2 0 1 Type A stainless steel cabinet will surround the apparatus 6 2 3 Service Area Location 6 2 3 0 1 Location Left side 6 2 3 0 2 Reference The from above sketch below show how the service area are located regarded to the sterilizer chamber and doors The control side 1s shown for reference SS OS Service Sterilizer Area Chamber Control Side 6 2 4 Chamber Internal Dimensions 6 2 4 0 1 Chamber width 720 mm 28 6 2 4 0 2 Chamber height 1050 mm 41 6 2 4 0 3 Chamber depth 1350 mm 53 6 2 4 0 4 Useable width 660 mm 26 6 2 4 0 5 Useable height 990 mm 39 6 2 4 0 6 Useable depth 1350 mm 53 6 2 4 0 7 Usable chamber volume 0 88 m3 31 ft3 6 2 5 Chamber Construction 6 2 5 0 1 Cross section Rectangular 6 2 5 0 2 Inter
39. configured for a specific range An entered value below or above the range will not be accepted by the control system The accepted maximum and minimum level is shown in the proximity of the operator interface input field For a description of adjustable parameters refer to FUNCTIONS WHICH ARE CONFIGURATIVE AND THEIR LIMITS Adjustable Process Pa rameters sections below 3 9 3 2 Access Restrictions 39 321 The following protected areas is supported by the control system A Parameter Settings B Time settings C Calibration D Boolean Password 1 e g used for pin code protected maintenance programs E Service GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page F Dip switches soft switches e g used for media monitoring G S Non process critical configuration e g graphs printer log etc H Process critical configuration e g AI DI DO FO etc I Boolean Code Application Software Code Programming J Password Setup K Documentation L Boolean Password 2 available for use in application software 3 93 22 The following roles will be configured as standard Table 2 oe a CI CO 5952 Up to 50 unique users may be defined 3 9 3 2 4 Each user consists of a user name with maximum 16 characters 39329 Password may be both numerical and alphanumerical 3 9 3 2 6 The minimum number of characters in a password is 3 and the mazimum is
40. ction for a description of the continued process The door blockage key TO THE RIGHT is used for personal safety to prevent door closing and process start during loading or chamber cleaning Two switch contacts are used for redundancy one to a control system digital input and another hard wired to the door closing supply valve GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo sd 3 33 60 5 2 Control side operator switches second row gt OS UA Y The operator controls on the second row consists of door open and close switches a combined alarm switch indicator and an alarm buzzer 5 2 1 Switch description 5 2 1 0 1 The door close switch located TO THE FAR LEFT is used to close the chamber door 5 2 1 0 2 The door open switch located BESIDE THE DOOR CLOSE SWITCH is used to open the chamber door 5 2 1 0 3 The alarm buzzer is located TO THE FAR RIGHT and is used for audible alarm indication by the con trol system 5 2 1 0 4 The alarm button indicator located BESIDE THE BUZZER is used for alarm reset by the operator and visible alarm indication by the control system GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 5 3 User Interface OP30 S CHAMBER TEMP C
41. d in stand by But steam is supplied to the door gasket during the filter program s as an extra precaution to prevent cross contamination The drain system is designed with a liquid ring mechanical pump that creates vacuum in the chamber and door gasket Getinge s unique water conservation system is used to limit the consumption of the city water by 50 during the process while guaranteeing maximum efficiency of the vacuum pump A pneumatic system is provided to control the operation of the air operated components of the appara tus The tubing is assembled to present a neat mechanical space Tubing is tagged along with the con nection point to assure proper replacement during servicing Steam supply A stainless steel shell and tube heat exchanger is provided to generate steam from a clean water source i e WEI Plant steam is applied to the shell of the heat exchanger generating steam from the clean water inside the tubes The system is integrated with the sterilizer and sized so that the customer does not have to provide the process steam utility Electrical system The electrical system is designed and built to harmonize with national and local electrical codes for the installation site refer to the Directives and Regulation section The entire electrical system is provided with circuit protection to protect it from voltage surges Motors are equipped with starters and appro priate circuit protection All wires and their connection point
42. e directed to the process printer for documentation All functions require C area access Ll The bridge tables menu provides features for input of bridge compensation table data used for cor rection of a pressure transducer input signal A report may be directed to the process printer for docu mentation All functions require C area access 5 3 3 2 8 The documentation menu provides access to the print cycle setup the printer and printer log value menus The function requires K area access 3 30 29 In the print cycle setup menu you can choose to print out program documentation phase list and parameter list for chosen programs or for all programs The function requires K area access 5 3 3 2 10 The printer menu provides functions to adjust the type of presentation for the data to be printed out and the length of the logging interval All functions requires K area access 5 3 3 2 11 The printer log value menu lets you build up lists in which you define the parameters that are to be included in the printout Each list lets you determine which parameters are to be included and in which order they will be arranged Three independent lists are available that is used for different programs All functions requires K area access Sao WA The configuration menu provides access to the edit cycles the machine name the language amp date units the panel setup and the extended para
43. e open button is located near the door hardware function 3 1 0 0 2 The close button 1s located near the door hardware function 3 1 0 0 3 The door force will not exceed 150N if obstructed hardware function 3 1 0 0 4 Media cannot enter the chamber unless the door is closed hardware function 3 1 0 0 5 The door opens entirely through a single button press software function 3 1 0 0 6 The door closes upon continuous button press 1 e dead mans thumb software function 3 1 0 0 7 The door is retracted if an obstacle prevents closing software function 3 1 0 0 8 The door s will not be able to open during process software and hardware function 3 1 0 0 9 The door will not be able to open if chamber pressure is above atmospheric refer to Media to chamber interlock and Door Opening Interlock in the SAFETY AND SECURITY section 3 1 0 0 10 The door shall not be able to open if the liquid temperature in a closed container exceeds 80 C refer 3 2 3 2 0 0 1 3 2 0 0 2 3 3 to Media to chamber interlock and Door Opening Interlock in the SAFETY AND SECURITY section Process Program Selection A new program is selected via the operating panel A new program can only be selected when a program is not running Process Start 3 3 0 0 1 A process 1s started through a start button press software function 3 3 0 0 2 A process cannot be started unless the door s are closed software function 3 3 0 0 3 A process cannot be started if a process ala
44. em Order reference Document No User User reference Version Page 9 References 3 GMP Impact Assessment Rationale available at Getinge Sterilization AB 4 Getinge Quality Management System QMS QMS 2000 Public 5 0 6 Getinge Validation Policy document 01 27 00 in QMS 2000 Public 5 0 9 Nationally Recognized Testing Laboratory 10 Technical Data Sheet separate document 11 Pre installation instruction separate document 12 The program combination separate document 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo sd E 60 60 10 Document history 2008 08 24 2005 01 21 Voltage changed in section 6 7 1 Condensate return added in section 6 4 High level alarm added in section 6 8 1 nae ah switch added in section 6 8 2 GE TINGE Rev B
45. ference Version Page 6 Mechanical Design Specification 41 6 1 Mechanical Enclosure 41 6 1 1 Fascia Panels Sata e E A E ie ate 41 6 1 2 Instrument Column AA 290 2 br a re 26 8 224 41 6 1 3 PIPING SKOS tee re Ry a e le A y ee ee eae 41 6 2 Pressure VESSELS oo AAA O A AE O ee 41 6 2 1 Chamber Configuration 41 6 2 2 Installation 40 6 2 3 Service Area Location 42 6 2 4 Chamber Internal Dimensions 42 6 2 5 Chamber Construction 42 6 2 6 Internal Chamber and Ports Finish 42 6 2 7 Chamber Ports 43 6 2 8 Validation Port A3 6 2 9 Jacket 43 6 2 10 DOO 42 a 2 ee ie Hala oa a aa ae as 44 6 2 11 Door 22h Se 8 AS AA oes Bee Seas 44 6 2 12 Door gasket 44 6 2 13 Inner lining 44 6 2 14 Ventilator System 44 6 2 15 Heat Exchanger for Cooling A5 6 2 16 Chamber Insulation Cladding 45 6 3 Steam supply A5 6 3 1 Clean steam generator 45 6 4 Media Connections AAA dede ae 86 6x 45 6 5 PIOCESS PIPING SAS AR AA AAA A Be 46 6 5 1 PII ClO sock sepa err cca WA Br
46. he digital input status The function is accessible through the menus service idiagnostics and requires E area access KE LL The digital output menu provides viewing and manual activation of the digital outputs The function is accessible through the menus service diagnostics and requires E area access 5 3 3 2 28 The system flag menu provides viewing of the system flag status The function is accessible through the menus service diagnostics and requires E area access 5 3 3 2 29 The user flag menu provides viewing of the user flag status The function is accessible through the menus service diagnostics and requires E area access 5 3 3 2 30 The printer menu sends and prints a test page on the process printer if existing The function is accessible through the menus service diagnostics and requires E area access ST e e The led buzzer activates all existing LED s and the buzzer The procedure reveals thus any audible or visible indicator malfunction The function is accessible through the menus service idiagnostics and requires E area access Ps is ROA Ps The PACS addresses menu is used for name definition of the PACS systems that are connected to the unit The function requires E area access io Hose E The save RAM to flash menu provides backup of the application software and the calibration values to the PROM The function requires G area access 5 3 4 Error handling and sec
47. here any need for the end user to perform an independent test The process will be doc umented with the normal process report functions included Water is needed to be able to perform the test We recommend to use at least dionized water As an option it is possible to connect to a water pipeline of e g cooled WFI 3 4 7 0 1 The process logging 1s started 3 4 7 0 2 If the temperature in the filter piping system is above 30 C a cooling phase is started to achieve a sta bilized temperature below that limit 3 4 7 0 3 The pressure in the filter piping system is adjusted close to atmospheric 3 4 7 0 4 A water tank becomes filled with water either from a manually filled water bottle or the optional alter native of filling from a pressurized water pipeline 3 4 7 0 5 The water tank becomes pressurized and this pressure is then used to fill the filter housing with water After a while the measuring point in the top of the filter housing becomes pressurized 3 4 7 0 6 A period of stabilization is needed 1 e by pulsing a valve when necessary the test pressure is kept 3 4 7 0 7 The water integrity test starts If the test fails the operator may choose between doing a re test or con tinue The test result is logged 3 4 7 0 8 After the test the water is drained The filter is then dried enough for being able to work according to its specifications This means that all moisture is not gone but enough The drying time is an adjustable parameter though 3
48. ing one additional temperature sensor located in close proximity to the drain temperature sensor and it is monitored by a independent system Digital read out of the secondary temperature sensor is provided to the operator 3 6 3 Condensate Level Sensor A condensate level sensor is installed down stream from the drain temperature sensor This ensures that the drain line temperature sensor is unaffected and that condensate does not come into contact with the product being sterilized An alarm will sound if condensate is detected in the drain line 3 6 4 Secondary Chamber Pressure Secondary pressure verification is furnished by including one additional pressure sensor located in close proximity to the chamber pressure sensor and it is monitored by a independent system Digital read out of the secondary temperature sensor is provided to the operator 3 6 5 Secondary Load Temperature 3 7 Secondary load temperature verification is furnished by including one additional temperature sensor located in close proximity to the load temperature sensor and it is monitored by a independent system Digital read out of the secondary temperature sensor is provided to the operator Process Report Functions 3 7 0 0 1 The process report consists of pre log data event logging intermediate data and post logging 3 7 0 0 2 Important batch and machine information will be printed in the pre log data 3 7 0 0 3 Major process changes such as phase shifts and process limits
49. is controlled and documented by the sterilization equipment s control system Removal of the filter housing or any associated piping is not required nor is there any need for the end user to perform an independent test 6 5 8 0 2 Testing media Water 6 5 9 Process Pressure Indicator Control Side 6 5 9 1 The control side will be provided with indicators for chamber jacket and incoming steam pressure 6 5 9 2 Chamber Pressure Indicator Control Side 6 5 9 2 1 Manufacturer WIKA 6 5 9 2 2 Type Bourdon tube with diaphragm isolation 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Malvern PA Renovations B 51 60 Sanofi Synthelabo 6 5 9 2 3 Process wetted material AISI 316L 6 5 9 2 4 Dial 1 5 Barg 0 30 inchHg 0 45 PSIG 6 3 9 2 9 Connection TriClover 6 5 9 3 Steam Pressure Indicator Control Side 6 5 9 3 1 Manufacturer WIKA 6 5 9 3 2 Type Bourdon tube with diaphragm isolation 6 5 9 3 3 Process wetted material AISI 316L 6 5 9 3 4 Dial 1 5 Barg 0 30 inchHg 0 45 PSIG 6 5 9 3 5 Connection TriClover 6 6 Non Process Piping All non process piping components are constructed of copper brass bronze stainless All piping are brazed or welded with flanged or threaded connections 6 6 1 Jacket Piping 6 6 1 1 Pipe Design 6 6 1 1 1 Pipe standard Metric 6 6 1 1 2 Material Copper Cu 6 6 1 1 3 Joints Threaded or flanged 6
50. is attained at all load sensors 3 4 4 0 4 The fan is not used during the first part of the cooling when the steam atmosphere collapses After a few minutes the ventilator fan starts The internal heat exchangers is cooled with water which then cools the fan distributed air The heat energy is removed from the load by the forced airflow Now the support pressure is controlled at a fixed high pressure since it makes the air atmosphere denser and a better heat conductor 3 4 4 0 5 The chamber pressure is adjusted close to atmospheric 3 4 4 0 6 The process logging is stopped 3 4 4 0 7 The sterilizer is ready for opening of the door s 3 4 5 Leak rate test cold The process is intended for verification of a process vessel not exceeding a leak rate affecting a sterile result The actual leak rate test will be performed subsequent to an included normal utensil program 3 4 5 0 1 The process logging 1s started 3 4 5 0 2 Air is removed in the chamber through vacuum pump evacuation down to 0 07 bar a 7 kPa a 1 0 PSIA 3 4 5 0 3 Allow the pressure to stabilize during 10 minutes before comparison 3 4 5 0 4 Compare the pressure rise during the next 10 minutes with the acceptance criteria 0 013 bar a 1 3 kPa a 0 19 PSIA The pressure must not exceed the criteria for a Process OK 3 4 5 0 5 The chamber pressure is adjusted close to atmospheric 3 4 5 0 6 The process logging is stopped 3 4 5 0 7 The sterilizer is ready for opening of the do
51. l the door to the chamber When the groove is under vacuum the gasket is retracted This prevents damage to the gasket during loading and unloading 6 2 12 0 3 Gasket sealing media Compressed air during sterilization Process steam during in line filter sterilization cycle to sterilize the gasket groove 6 2 12 0 4 Gasket retraction Liquid ring vacuum pump 6 2 13 Inner lining 6 2 13 0 1 Design Ensures that the airflow within the chamber is consistent and even 6 2 13 0 2 Material AISI 316L stainless steel 6 2 14 Ventilator System 6 2 14 0 1 Quantity of fans 1 6 2 14 0 2 Motor design 2 speed 6 2 14 0 3 Motor manufacturer ABB with custom shaft 6 2 14 0 4 Motor shaft material Duplex stainless steel corresponding to AISI 329 6 2 14 0 5 Motor shaft seal type Pressurized mechanical seal using condensed steam to seal 6 2 14 0 6 Mounting Flange mounted through the top of the chamber 6 2 14 0 7 Fan blade design Radial centrifugal 6 2 14 0 8 Fan material Acid proof stainless steel corresponding to AISI 316 25 GE TINGE Rev B User Sanofi Synthelabo 6 2 15 6 2 15 0 1 6 2 15 0 2 6 2 15 0 3 6 2 15 0 4 6 2 16 6 2 16 0 1 6 2 16 0 2 6 2 16 0 3 6 2 16 0 4 6 2 16 0 5 6 3 6 3 1 6 3 1 0 1 6 3 1 0 2 6 3 1 0 3 6 3 1 1 6 3 1 1 1 6 3 1 1 2 6 3 1 1 3 Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User reference Version Page Malvern PA Renovations B 48 60
52. lated with non heat resistant PVC depending on application 1 e if the cable is inside the steam en vironment or not 5 4 1 2 Manufacturer 5 4 1 2 1 Pentronic 5 4 1 3 Methods for measurement 5 4 1 3 1 A sensor element is used as a passive resistance emitter connected through a 4 wire cable to the control system 5 4 1 3 2 The control system creates a current and monitors the voltage over the sensor 5 4 1 3 3 Circuits and software to assure linear readings is included in the control system 5 4 1 3 4 Functions for calibration and correction available from the operator interface are included in the control system system software 5 4 1 4 Error handling recovery and reporting 5 4 1 4 1 A temperature sensor shall operate within a configured range 5 4 1 4 2 A temperature sensor with a leakage current to the ground shall be detected 5 4 1 4 3 A sensor out of range or with leakage current will result in a failure alarm Refer to PROCESS ALARMS failure alarms 5 4 1 5 Security 5 4 1 5 1 Process sensors regarded as critical for safety or with GMP impact are redundant and connected to the independent system PACS Supervisor 5 4 2 Pressure sensors 25 GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 5 4 2 1 Type 5 4 2 1 1 Diaphragm sealed piezo electric emitter 5 4 2 2 Manufacturer 5 4 2 2 1 Keller AG 5 4 2 3 Methods for measurement 5 4 2 3 1 The sensor is used as a
53. lization of filters and delicate non liquid components The com ponents are protected from rapid pressure and temperature changes through the use of ramp controllers 25 GE TINGE Rev B Document type Functional Specification System Order reference Document No V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo alanad E 16 60 3 4 2 0 1 Jacket heating is on through the entire program 3 4 2 0 2 The process logging 1s started 3 4 2 0 3 Atr 1s removed in the chamber atmosphere and load through repeated evacuation and steam injection to a pressure just above atmospheric The fan starts and runs in low speed mode The dilution continues for an adjustable number of pulses The pressure change rate 1s controlled not to exceed an adjustable value 3 4 2 0 4 Steam 1s injected and condenses removed in order to heat up the chamber atmosphere and load to ho mogeneous sterilization temperature The process continues to sterilization when all sensors have met sterile temperature The pressure change rate is controlled not to exceed an adjustable value 3 4 2 0 5 Physical sterilization is controlled at a selected hold temperature for a pre determined time 3 4 2 0 6 Load drying 1s performed at a pressure below 0 1 bar a 10 kPa a 1 45 PSIA through evacuation The drying shall continue for an adjustable time The pressure change rate is controlled not to exceed an adjustable value 3 4 2 0 7 The fan is stopped The cham
54. ls in the manuals are calculated for normal operation which is defined in section Life time in MAINTAINABILITY below 7 1 1 0 2 The equipment is designed for normal operation 7 1 1 0 3 Spare parts are available for at least 10 years after delivery 7 1 2 Redundancy No arrangements for redundant availability are provided 7 1 3 Error checking No arrangements for error checking with concern to availability are provided 7 1 4 Stand by operation 7 2 The equipment may be operated from cold or 100 C Jacket temperature the availability for operation 1s Improved with hot jacket refer to CONFIGURATIVE FUNCTIONS AND THEIR LIMITS System configuration sections above Maintainability 7 2 1 Service Access 7 2 1 0 1 Refer to PRESSURE VESSEL Chamber Configuration section above for information about service area location 7 2 1 0 2 Refer to MECHANICAL ENCLOSURE Service Door section above for information about access 7 2 2 Expansion amp enhancement possibilities 7 2 2 0 1 The control system support expansion up to 64 digital inputs with opto coupler isolation and internal 24 Volt DC supply Tez AA 2 The control system support expansion up to 64 digital outputs with normally open relay contacts 7 2 2 0 3 The control system support expansion up to 24 analog inputs with temperature pressure or general pur pose interface 7 2 2 0 4 The control system support expansion up to 8 analog general purpose outputs 7 2 3 Spare capacity In general is 10
55. meters menus The function requires G area access Se AA E The edit cycles menu provides functions for editing the program number and name When changing the name an alphanumeric keyboard pops up All functions requires G area access 5 3 3 2 14 The machine name menu provides functions for updating the machine name used on screen and in process reports When changing the data an alphanumeric keyboard pops up All functions requires G area access ZO The language amp date units menu provides functions for updating menu language date format units of pressure Bar PSI kPa and temperature C F All functions requires G area access 5 3 3 2 16 The panel setup menu provides among other things selection screen saver and of the type of basic menu to be displayed after booting up All functions requires G area access K zed The extended parameters menu provides functions for editing process P parameters All editing re quires G area access 5 3 3 2 18 The system setup menu provides functions for editing the machine node number The menu also provides enabling or disabling of the print last cycle function and the cycle CHR function All functions requires H area access 25 GE TINGE Rev B Document type Functional Specification System Order reference Document No V30259 5101874 T1705 User User reference Version Page Malvern PA Renovations B 39 60 Sanofi Synthelabo 3 3 3 2 19
56. minating the need for any external carbon steel supports of the chamber and allows visual inspection of all welds NOTE The sketch below is generic with few details and intended for improved understanding The exact chamber configuration may be different refer to relevant sections for valid data regarding cham ber dimension 6 2 9 0 1 Jacket design Sectional U formed profiles welded around the chamber 6 2 9 0 2 Jacket material AISI 31611 1 4571 stainless steel 6 2 9 0 3 Design pressure 3 0 bar g 45 PSIG 6 2 9 0 4 Jacket connections Threaded GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 6 2 10 Doors 6 2 10 0 1 Quantity 1 6 2 11 Door 6 2 11 0 1 Design Fully automatic horizontally sliding 6 2 11 0 2 Opening and closing Automatic button controlled 6 2 11 0 3 Door operation Pneumatic motor 6 2 11 0 4 Door safety Stops if obstructed 6 2 11 0 5 Internal door surface AISI 316T1 stainless steel 6 2 11 0 6 Door reinforcements SA516 Gr60 corrosion protected carbon steel 6 2 11 0 7 Door retainers SA516 Gr60 corrosion protected carbon steel 6 2 11 0 8 Door pins AISI 316 stainless steel 6 2 12 Door gasket 6 2 12 0 1 Design Seamless hollow gasket o ring of heat resistant silicon rubber 6 2 12 0 2 Operation The gasket is mounted in a groove that runs around the chamber opening When the groove is pressurized the gasket is pushed out against the door surface to sea
57. mpleted process The light is illuminated green for a successful process and red for a failed stepped or held process 5 30 12 A red LED indication is provided for a process failure alarm 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 5 3 1 0 13 5 3 1 0 14 5 3 1 0 15 5 3 2 53201 5 3 2 0 2 S e RAN KR e KBC 5 3 3 1 4 5 3 3 1 5 5 3 3 1 6 User reference Version Page Sanofi Synthelabo Malvern Pee Renovanons B 35 60 A yellow LED indication is provided for a closed door or a door moving towards closed position The LED is integrated in the door close button A yellow LED indication is provided for an open door or a door moving towards open position The LED is integrated in the door open button A yellow LED is provided to indicate ready to be started The LED is integrated in the start button Definition of user roles All roles defined in section FUNCTION Safety and Security Access Restrictions apply to the OP30 with one exception described below Programming of Boolean code can not be made access area I Functions available Operator functions COLD START DISPLAY DETAILS PLOT GRAPH BAR GRAPH SETUP SELECT CYCLE PARAMETERS MORE PASSWORD DETAILS PLOT GRAPH EDIT PARAMETERS BAR GRAPH PRINT LAST CYCLE SYSTEM MENU ABOUT Most of the operator functions are unrestricted and do not require a specific area a
58. ms amp Messages 15 3 5 1 Failure Alarms 15 3 5 2 Warning Messages 17 3 5 3 Information Messages 17 GE TINGE Rev B Document type User System Order reference Document No V30259 5101874 T1705 User reference Version Page Malvern PA Renovations B 3 60 3 6 GMP Functions 19 3 6 1 Temperature Distribution 19 3 6 2 Secondary Drain Temperature 19 3 6 3 Condensate Level Sensor 19 3 6 4 Secondary Chamber Pressure 19 3 6 5 Secondary Load Temperature 19 3 Process Report Functions 19 3 8 FEMOMMANCe 2 2625 eS Poets AAGA Ge 20 3 8 1 FIESPORSC TMG gt Se ee oe Se eS ee SE ee Sc 20 3 8 2 Temperature resolution and accuracy 20 3 8 3 Pressure resolution and accuracy 20 3 8 4 MNE AC CUA wA A A A AAA AR 20 3 9 Safety and security 20 3 9 1 Operator safety AA e A e A Se 20 3 9 2 Data integrity 21 3 9 3 Sisi Mm SS 088 cat 2 00 Roe ee eee e LR eee 22 3 10 Configurative functions and their limits 23 3 10 1 Adjustable Process Parameters 23 3 10 2 System Configuration 26 4 D
59. n upon a button press Step a printed only warning for a process stepped without meeting a condition High condensate level a warning for too high condensate level in the drain Information messages General features for information messages An information text function has no audible indication 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page E N Ip An information text function don t affect the door control refer to DOOR FUNCTIONS Ee e ES A specific text shall highlight a certain condition that will prevent the machine from starting a cycle 1 e Prevented start messages or is used to show conditions that are not sufficient to cause a failure of the cycle 1 e Service messages Process report messages and Process information messages 3 5 3 1 4 The function does not require any reset procedure it disappears when the fault condition is gone 3 5 3 1 5 The cycle response is non GMP critical resulting in a Process OK printout on the report 3 5 3 2 Specific features for Prevented start messages S WA The messages are associated with conditions that will prevent a cycle from starting Za Z The start button indication light will not be activated ER H O Messages are displayed during five 5 seconds upon start trials on the operator panels when start but ton 1s pressed 3 5 3 3 List of Prevented start messages 3
60. nal corners Radius 75 mm 3 6 2 5 0 3 Material AISI 316T1 acid proof stainless steel 6 2 5 0 4 Design pressure 3 bar g 45 psig amp full vacuum 6 2 5 0 5 Welds Robotic or semi automatic whenever possible 6 2 6 Internal Chamber and Ports Finish 6 2 6 0 1 Internal surface Ground and polished to a high luster 6 2 6 0 2 Internal Ra value 0 5 microns 0 13 20 micro inches 5 6 2 6 0 3 Internal door surface Ground and polished to a high luster GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 6 2 6 0 4 Internal door surface Ra value 0 5 microns 0 13 20 micro inches 5 6 2 7 Chamber Ports 6 2 7 0 1 Construction Pressure vessel piping welded to the chamber 6 2 7 0 2 Quantity According to Getinge QMS design standard K048 GE Sterilizer K049 GEV Sterilizer KO50 GEC Sterilizer 6 2 7 0 3 Material Equal to the grade of the chamber material 6 2 7 0 4 Connections Tri clamp 2 6 2 7 0 5 Slope Greater than 2 6 2 7 0 6 Maximum deadleg 6x the pipe diameter 6 2 8 Validation Port 6 2 8 0 1 Construction Pressure vessel piping welded to the chamber 6 2 8 0 2 Quantity One 1 6 2 8 0 3 Size Tri clamp 2 6 2 8 0 4 Material Gr 316L 6 2 8 0 5 Connections Tri clamp capped 6 2 8 0 6 Slope Greater than 2 6 2 9 Jacket The jacket is a series of U channels continuously welded to the chamber The sectional jacket design adds the structural rigidity while eli
61. ocess printer capacity maybe selected but not executed 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 4 4 1 User reference Version Page Sanofi Synthelabo dl ME 30 60 Data PACS3000 data flow general layout A brief description of the control system data flow 1s provided in this document The PACS3000 gen eral data flow architecture is designed in the development of the control system Refer to the develop ment project QAPP 565 11 94 issue 4 for more detailed documentation The referred documents are available for audit at Getinge Sterilization AB Sweden CPU lO RS232 RS485 Printer RS232 S Operator p v gt UPerviSor Panels 4 1 1 4 1 1 1 4 1 1 2 4 1 1 3 4 1 1 4 4 1 2 VO data All I O data is updated 4 times a second in the CPU RAM Digital input The current statuses for digital inputs are read in to the I O database part of the CPU RAM Digital output The digital output statuses are stored in the I O database part of the CPU RAM The system and appli cation software updates the status in the I O database upon execution in the processor Analogue input The analogue value from each sensor is converted to a digital raw value in the A D converter The raw data value is converted by the CPU to the correct physical units and is m
62. ontained within 1 2 Contractual status The User shall approve this document This document will gain contractual status when the signatories in the front page are processed GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User Sanofi Synth elabo Malvern PA Renovations B 2 1 2 1 1 2 1 2 2 1 3 2 1 3 1 2 1 3 2 User reference Version 7 60 Overview Key objectives and benefits Confidence We respect our client s requests to protect information relating to particular operations and products We request that similar confidentiality be extended to us and ask that this document and related infor mation is not copied to third parties without our permission The Sterilizer Objective This specification describes a high performance Getinge ventilator sterilizer The sterilization process 1s an automatic batch process performed in a closed chamber pressure vessel Each process recipe 1s optimized for a product group and controlled by a control system a PLC The apparatus is specifically designed for sterilization of products that are pressure sensitive e g liquids in sealed glass or plastic containers The ventilator system also makes it possible to rapidly cool and dry the product after steri lization The product is counter balanced with air to ensure that the product 1s not damaged from inter nal or external pressure
63. oor are provided with rails for guidance Process Piping The process piping includes all internal chamber components and media lines to the chamber including isolating valves to non process piping The definition of where the process piping in the media line for process air starts is at the downstream side of the sterile air filter Valves and major components are arranged to be easily accessible or removable for servicing and replacement The equipment is provided with a sterile air filter and housing to provide sterile filtered compressed air when support pressure is needed in the process Functions for automatic in situ integrity test Water Intrusion Test WIT are provided Non Process Piping The non process piping includes piping that is not directly in contact with the product process steam or sterile air such as the jacket piping door gasket piping and drain system piping Valves and major components are arranged to be easily accessible or removable for servicing and replacement The equipment will be furnished with recirculation utility connections for the cooling water The cool ing water recirculation loop is used to cool the effluent of the apparatus drain and it reduces the con sumption of potable water that is necessary to run the equipment This option may be connected to the user s cooling water return system while installing the equipment The door gasket piping will be supplied with sterile filtered air during process an
64. or s 3 4 6 Program for in situ air filter sterilization Sterilization in place SIP An automatic process 1s provided for regular in situ sterilization of the sterile grade gas filter to mini mize the risk of bacterial grow through The process will be documented with the normal process report functions included 3 4 6 0 1 The process logging 1s started 3 4 6 0 2 The pressure in the filter piping system 1s adjusted close to atmospheric 3 4 6 0 3 Steam 19 injected into the filter piping system and the drain is opened to remove air and condensate The process continues to sterilization when the sensor is above sterile temperature GE TINGE Rev B Document type Functional Specification System Order reference Document No V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo Malvern Pe Ronovanons B 18 60 3 4 6 0 4 Physical sterilization is controlled at a selected hold temperature for a pre determined time 3 4 6 0 5 The filter is gently cooled until a pre determined temperature is reached since a warm filter is sensitive to high differential pressure 3 4 6 0 6 The process logging is stopped 3 4 7 Program for in situ air filter integrity test Water Intrusion Test WIT An automatic process is provided for regular in situ integrity test of the sterile grade air filter to assure the sterility and function of the filter Removal of the filter housing or any associated piping is not re quired nor is t
65. passive emitter connected through a cable to the control system JA The control system creates currents and monitors the voltage over the sensor 5 4 2 3 3 The sensor includes a temperature sensor and is temperature compensated by the control system 54 234 Circuits and machine ware for linearization 1s included in the control system 5 4 2 3 5 A unique Whetstone compensation bridge and a correction table are used in the control system for cor rection 5 4 2 3 6 Functions for calibration and correction available from the operator interface are included in the control system system software 5 4 2 4 Error handling recovery and reporting 5 4 2 4 1 A pressure sensor shall operate within a configured range 5 4 2 4 2 A sensor out of range will result in a failure alarm Refer to PROCESS ALARMS failure alarms 5 4 2 5 Security 5 4 2 5 1 Process sensors regarded as critical for safety or with GMP impact are redundant and connected to the independent system PACS Supervisor The PACS Supervisor Refer to the development project with QAPP 565 11 94 issue 4 titled Quality and Project Plan P2000 CPU ver3 for more information The referred documents are available for audit at Getinge Sterilization AB Sweden 5 5 0 1 Functions 5 5 0 1 1 The PACS Supervisor is an independent monitoring and documentation system that receives process readings from the control system and compares them with own independent sensors IDO The system is connected
66. results in event logging printouts 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 3 7 0 0 4 Additional low speed event printouts will be made during pre and post treatment refer to Functions which are configurative and their limits 3 7 0 0 5 Additional high speed event printouts will be made during the hold period refer to Functions which are configurative and their limits 3 7 0 0 6 Process alarms will be printed out as intermediate data when they happen 3 7 0 0 7 Process holds or manual steps will be printed out as intermediate data when they happen 3 7 0 0 8 A stepped held or faulty process will be printed PROCESS FAILURE in the post logging 3 7 0 0 9 A successful process will be printed PROCESS OK in the post logging 3 8 Performance 3 8 1 Response time Process controllers inputs and outputs are updated every 250 milliseconds 3 8 2 Temperature resolution and accuracy 3 8 2 0 1 Temperature measure circuits which include sensors and Al cards have 0 1 C resolution 3 8 2 0 2 Inaccuracy is less than 0 1 C 3 8 2 0 3 Temperature resolution and inaccuracy also applies to PACS Supervisor 3 8 3 Pressure resolution and accuracy 3 8 3 0 1 Pressure measure circuits have 0 001 bar 0 1 kPa resolution or 0 01 PSI for English units 3 8 3 0 2 Inaccuracy below 0 01bar 1 kPa 0 145 PSI in range 0 1bar a 0 100 kPa a 0 14 5 PSIA 3 8 3
67. rm is active software function 3 3 0 0 4 A process can only be started 1f the process printer is not active or 15 minutes after previous process 3 4 end software function Process Program Combination V3110 The program combination has been designed for sterilization of a variety of items such as utensils tex tiles filters liquids in sealed plastic and glass containers All programs are initiated from a non process state as indicated on the operator interface A program may not be started unless the sterilizer door s is completely closed and no alarm conditions exist Jacket heating to a temperature close to sterilization is used where appropriate in the vacuum programs in order to reduce steam consumption and achieve homogenous temperature distribution In programs for sterilization of sealed plastic or glass containers an internal fan improves heat exchange during both heating and cooling and the containers structure is supported by sterile filtered compressed air In vacuum programs the fan runs on low speed The program combination includes different recipes according to table below GE TINGE Rev B Document type System Order reference Document No User User reference Version Page Table 1 Utensils glassware textiles plastic and rubber Vacuum cycle products ea A CO CC UTC 3 4 1 Vacuum cycle The process has been designed for sterilization of a variety of items The recipes to the program may be
68. s is are suspended on sealed bearings and a simple pneumatic motor operates the any door The pneumatic motor is de signed to operate with a minimal amount of force allowing for intrinsically safe personnel protection The door s is are sealed by an active silicon rubber O ring gasket and is are fitted in the stainless steel groove of the respective chamber head ring Mechanical and electrical devices prevent the user from opening the any door while the process is running The chamber and door s are insulated The insulation is contained in a sheet metal casing The cham ber and jacket are designed to operate at full vacuum and up to the maximum allowable pressure Safety relief devices for both the chamber and jacket are supplied when required in accordance with applicable code requirements 2 3 3 3 Loading Equipment If loading equipment is included it is specified in the contract between the Getinge Sales Company and the User 2 3 3 4 Loading Equipment ZS GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User Sanofi Synth elabo Malvern PA Renovations B 2 3 3 5 2 3 3 6 2 3 3 7 2 3 4 2 4 User reference Version 12 60 The equipment includes loading trolleys with shelves for smooth load handling through the sterilizer The trolleys are provided with hooking and latching devices The chamber floor and adjacent external fl
69. s are individually marked and noted on the electrical drawings Wires are installed in open wire conduits where practical with high voltage wires routed separately Wiring for field devices located outside the enclosure utilize multiple conductor in sulated cord and are sealed with water tight connections Main interfaces from the system to other systems or the envi ronment GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 2 4 1 2 4 2 2 5 2 5 0 0 1 2 5 0 0 2 2 5 0 0 3 User reference Version Page Sanofi Synthelabo sd E 13 60 Control system interfaces e User Interface Operating panels amp controls e Inputs amp Outputs e Process printers e Power supply Mechanical system interfaces e Utilities e Drains e Loading equipment Assumptions The apparatus is only used for sterilization of material or equipment in accordance with PROCESS PROGRAM COMBINATION Utilities are provided according to the Technical Data Sheet 10 The installation is performed according to the pre installation instructions 11 and the subsequent in stallation instructions in the service manual GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo PA B 14 60 3 3 1 Functions Door functions 3 1 0 0 1 Th
70. s during the process A fan system mixes the air and steam to provide a homogenous environment The temperature distribution during sterilization 1s well within the accepted industry norm of one degree C between the coldest and highest temperature within the chamber Cool ing of the product is achieved through passing cool water through heat exchangers installed inside the chamber Compressed air is added to the chamber to prevents boiling or expansion of the product counter balance The fan system circulates the chamber environment across the heat exchangers rap idly cooling and removing moisture from the environment No cross contamination can occur between the cooling media and the product An inner liner shroud ensures that the airflow within the chamber is consistent and even GMP Impact Design approach The design and construction of the sterilization equipment minimizes the risk for errors dangerous sit uations and product contamination through e The use of non corrosive and non toxic material in direct or indirect product contact e The use of a design that enables drain ability and avoids dead legs e The uses of accurate and verified control system measure circuits normally temperature amp pressure e The use of design and process which enables uniform temperature distribution e The use of process alarms which detects unexpected and potentially critical conditions e The use of verified processes that assure product sterilit
71. ss report messages E Process OK is set upon a successful process 2s GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page K NA Safety Interlock is set if the monitoring relay system is not corresponding with the control system the recorded texts are identical to the failure alarms e g door interlock gasket interlock 3 5 3 8 Specific features for Process information messages 3 5 3 8 1 The messages are only displayed on the operating panel 3 5 3 9 List of Process information messages 3 5 3 9 1 Equalize Manually displayed when a manual equalization by user is expected holds the process bin he o 1 Step Manually displayed when a manual step by the user is expected holds the process 3 6 GMP Functions Getinge Sterilization AB has incorporated features in the sterilization equipment to meet or exceed cur rent Good Manufacturing Practices CGMP In GmP Impact Assessment Rationale 3 which is avail able for user audit at Getinge Sterilization AB further information of the rationale to the features in this section 3 6 1 Temperature Distribution The temperature distribution within the chamber has a maximum variation of plus or minus 0 5 C from the mean chamber temperature during a measured time period once stabilization is achieved 3 6 2 Secondary Drain Temperature Secondary drain temperature verification is furnished by includ
72. stem for questions and status information 5 5 0 4 2 Master Supervisor Slave control system 5 5 0 5 Timing 5 0 0 5 1 Requests are transmitted every second to the control system 5303 2 Data is received from the control system when the control system decides to answer 5 5 0 6 Protocol and rate of data transfer 5 5 0 6 1 RS232 Serial Interface 5 5 0 6 2 57600 bits second 5 5 0 7 Communication between Supervisor and control system 5 5 0 7 1 The Supervisor uses the control system serial interface buffer for all communication 5 5 0 7 2 The Supervisor has no access to internal data in the control system 5 5 0 8 Error handling 5 5 0 8 1 All sensors shall operate within a configured range 5 5 0 8 2 A pressure sensor out of range is presented and printed 9 999 5 5 0 8 3 A temperature sensor out of range or with leakage current is presented and printed 999 9 5 5 0 9 Safety amp Security 5 5 0 9 1 The Supervisor is based on identical hardware as the control system so the SAFETY amp SECURITY 5 6 5 6 0 0 1 5 6 0 0 2 power failure backup amp recovery and disaster recovery sections applies to PACS Supervisor Report interface Cobex thermal printer Type thermal printer Location panel mounted 25 GE TINGE Rev B Document type Functional Specification User Sanofi Synthelabo 5 6 0 0 3 5 6 0 0 4 5 6 0 0 5 5 6 0 0 6 5 6 0 0 7 5 6 0 0 8 5 6 0 0 9 5 6 0 0 10 Paper supply Paper width Paper roll length Prin
73. stop signal to the control system and an independent hard wire circuit to supply valves are provided The door can not be opened when the emergency stop 1s activated S e The control system monitors the chamber pressure and the equipment is provided with independent pressure interlock circuits to the door seal drain and door opening valves 39 133 The control system monitors the load temperature and the equipment is provided with independent tem perature interlock circuits to the door seal drain and door opening valves 3 9 1 3 4 The door seal pressure can not be relived or the door opened if the chamber pressure is above or below atmospheric The control system will only leave equlization when the pressure is at atmospheric 0 05 bar 5 kPa 40 7 PSI The independent system will not supply control voltage when the pressure ex ceeds 1 2 bar a 120 kPa a 17 5 PSIA 3 9 1 3 5 This interlock applies to a cooling process with support pressure for liquid in closed containers The cooling can not be terminated and the door subsequent opened if the temperature exceeds 80 C during end of process 3 9 1 4 Self Checks A self check of the hard wire door interlock system will be performed to assure a working system that prevents the door from being opened or media being entered unless safety is guaranteed 3 9 1 4 1 The control system monitors the independent interlock circuit and checks for the expected status at known process checkpoints 3 9 1
74. t No Functional Specification User User reference Version Page 6 4 0 0 5 Circ Cooling water External Water Supply 6 4 0 0 6 Circ Cooling water return External Return 6 4 0 0 7 Condensate return 6 5 Process Piping 6 5 0 0 1 Material Certificate Included refer to the ORDER DELIVERABLES sheet for definition of all included test reports 6 5 0 0 2 Type 3 1 B for welded componets and other components when available Type 2 2 for all other process wetted parts 6 5 1 Piping Design All process piping components are constructed of high grade stainless steel Stainless steel piping in contact with clean steam and sterile air are orbital welded pipes with tri clamp connectors 6 5 1 0 1 Pipe standard US O D 6 5 1 0 2 Material AISI 316L stainless steel tube 6 5 1 0 3 Internal surface finish 0 5 micrometer 12 7 micro inches 6 5 1 0 4 Welding Automatic orbital machine welds 6 5 1 0 5 Joints equal or smaller than 3 Tri clamp 6 5 1 0 6 Joints larger than 3 Stainless steel flange 6 5 1 0 7 Maximum deadleg 6x the pipe diameter 6 5 1 0 8 Minimum slope towards drain 1 6 5 1 0 9 Insulation Hot and cold pipes 6 5 2 Valve Design 6 5 2 0 1 Valve manufacturer s Gemii ASCO 6 5 2 0 2 Body material Stainless steel 316L 6 5 2 0 3 Gemu valve type Globe piston 6 5 2 0 4 Asco valve type Solenoid 6 5 3 Chamber Safety Valve 6 5 3 0 1 Material Brass 6 5 3 0 2 Regulatory Meets or exceeds the standards for the country of destination 6 5
75. t speed Printer buffer Power supply Power consumption Communication System Order reference Document No V30259 5101874 T1705 User reference Version Page Malvern PA Renovations B 43 60 paper roll 2 3 8 60 mm 75ft 22 86 m 1 Line per second 8151 characters supplied from the control system transformer up to 48 watts serial RS232 interface baud rate 9600 bps GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 6 Mechanical Design Specification 6 1 Mechanical Enclosure 6 1 1 Fascia Panels 6 1 1 0 1 Material Stainless steel 1 4301 304 6 1 1 0 2 Front surface texture Tetra polished Ra lt 1 2 micrometer 6 1 1 0 3 Thickness 1 5 mm 0 06 6 1 1 0 4 Fascia panel design Double folded partially welded 33 mm 1 La 6 1 1 0 5 Panel Support 30 mm 1 44 squared hollow bar with screw joints 6 1 1 0 6 Construction Recessed installation with 33 mm panels mounted in front of the walls with overlap 6 1 2 Instrument Column The side mounted instrument column consists of modular extruded aluminum sections in order to house all selected instruments and controls The top and bottom sections are anodized in a dark blue color and the intermediate sections are powder coated in a light blue color 6 1 2 1 Location 6 1 2 1 1 Control side Beside the chamber door 6 1 2 2 Top amp Bottom Section 6 1 2 2 1 Material Extruded aluminum profile 6122 2 Surfa
76. t strings The text strings 1s transferred to the process printer over a RS232 serial interface The application software calls for printout at temperature and pressure limits upon process phase shifts and at periodical occa sions Refer to the INTERFACE section for a more detailed description 25 GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User 5 9 1 User reference Version Page Sanofi Synthelabo sd E 32 60 Interfaces Control Side Operator Switches O l 5 1 1 5 1 1 0 1 5 1 1 0 2 5 1 1 0 3 The operator controls consist of a control system power switch an emergency stop switch and a door blockage key The switches are located in the loading door proximity at an ergonomically correct height below the operating panel Switch description The control system power switch TO THE LEFT is used to turn off and on the control system power amp electrical devices connected to the control system transformer such as printers pilot valves and in struments The emergency stop IN THE MIDDLE is used to stop the process and shut down pumps motors and incoming media Two switch contacts are used for redundancy one to a control system digital input and another hard wired to media supply pilot valves The emergency stop activates a process alarm when used during process refer to the PROCESS ALARM se
77. the menu tree The system menu is accessible through the setup drop down menu The about menu displays among other things the control system in the form of version information for the panel and the control system The menu also provides functions for adjustment of the display brightness The about menu is accessible through the setup drop down menu The select cycle menu provides selection of any available process program The parameters menu provides viewing and editing of non critical adjustable process parameters for the selected program Area password A is required for editing The more menu gives access to functions and menus that are initiated in the Boolean application software If no such functions exist will this field be blank If only one function is defined will the more menu be replaced by the Boolean function System functions GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo sd E 37 60 SYSTEM PASSWORD TIME SETTINGS CALENDAR ALARM CLOCK CALIBRATION MANUAL CALIBRATION AUTOMATIC CALIBRATION BRIDGE TABLES DOCUMENTATION PRINT CYCLE SETUP PRINTER PRINTER LOG VALUES CONFIGURATION EDIT CYCLES MACHINE NAME LANGUAGE amp DATE UNITS PANEL SETUP EXTENDED PARAMETERS DESENI TITI SYSTEM SETUP PASSWORDS DIPSWITCHES SERVI
78. to the report interface and prints all process data on one process report 5 5 0 1 3 Refer to FUNCTIONS Process report functions and INTERFACES Report Functions for a description of the process printer functions used by the supervisor 5 5 0 1 4 The PACS Supervisor utilize the same user interface as the control system Refer to USER INTER FACE Functions available Operator functions Select PACS 5 5 0 1 5 The Supervisor is used as an independent 5 5 0 2 Performance 5 5 0 2 1 The Supervisor is based on identical hardware as the control system 2s GE TINGE Rev B Document type System Order reference Document No Functional Specification User User reference Version Page 3 2 0 2 2 Timer inaccuracy 1s identical to the control system 5 5 0 2 3 Temperature resolution and inaccuracy is identical to the control system 5 5 0 2 4 Pressure resolution and inaccuracy is identical to the control system 5 5 0 3 Data transmitted and received 5 5 0 3 1 The Supervisor reads start and stop requests for printing in the control system 3902 The Supervisor reads slow or fast printing requests in the control system 5 5 0 3 3 The Supervisor reads event printing requests in the control system 5 5 0 3 4 Status information is transmitted to the control system for 5 dedicated system flags 5 5 0 3 5 Process data is received from the control system 5 5 0 4 Data format and interruption 5 5 0 4 1 Comli language is used in communication with the control sy
79. tual pressure is higher than the calculated saturation pressure a margin during sterilization Leak Rate Test Failure the pressure increase exceeds 13 mbar 10 minutes during leak rate test Massive Leak the leak test is aborted due to a leak resulting in a pressure above 0 5 bar a during sta bilizing Bursting disc is set if the bursting disc is broken Warning messages Features of warning messages Warning messages are used on a cycle in progress to indicate an override condition An override condition requires an active authorization key A warning messages has no audible indication A specific text will be printed in the process report when the condition occurs A specific text will be displayed on the user interface when the condition occurs Warning messages affects the door control refer to DOOR FUNCTIONS Stepping through critical or potentially dangerous conditions must not be possible without meeting the critical condition After a warning message The cycle will proceed normally The Process Complete light is red at the end of the process instead of green to indicate a failed proc ess Process Failure 1s printed in the end of the process report The warning message does not require any reset procedure Warning message list Sequence hold a warning for a process hold at the next main condition through an activated authori zation key The process continues from the held condition to the next main conditio
80. urity 5 3 4 0 1 Power failure is not critical nothing will be lost since all software is stored and executed directly in the operator interface PROM s 5 3 4 0 2 A communication failure between the control system and the user interface board will be highlighted by a communication failure pop up screen The screen disappears once the communication is rees tablished 25 GE TINGE Rev B Document type System Order reference Document No User User reference Version Page 5 3 4 0 3 Backup and recovery is not applicable since all user interface software is stored and executed directly in the user interface PROM s All critical data is stored in the control system not in the user interface 5 3 4 0 4 Disaster recovery the user interface is normally replaced if it fails 5 3 4 0 5 The use of RS422 communication protocol with flow control ensures a safe and reliable data transfer between the control system and the user interface 5 3 4 0 6 The hardware and connections complies with the EMC directives and the FCC rules The compliance assures integrity low emissions and flicker absence Interface with equipment 5 4 1 Temperature sensors The equipment is provided with necessary temperature sensors for all included functions 5 4 1 1 Type 5 4 1 1 1 Pt100 Class A RTD sensor with single or dual element and cable 5 4 1 1 2 The sensor wiring are either insulated with steam and heat resistant and pressure tight silicon rubber or insu
81. y and reproducible result e The use of a design which permits effective cleaning and maintenance in order to avoid cross con tamination builds up of dust and dirt and in general adverse conditions that could affect the product quality e The use of safety analysis as a tool to assure safety for personnel and property e Anergonomic design approach e g the equipment shall not exceed a noise level above 70dB a meas ured 1 meter from the user interface Risk analysis based classification of requirements The requirements and functions are classified in categories depending of the risk e GMP critical requirements referenced may be exposed to on site qualification practices k GE TINGE Rev B Document type System Order reference Document No Functional Specification V30259 5101874 T1705 User User reference Version Page Sanofi Synthelabo ii 8 60 Non GMP critical requirements referenced is tested and verified in accordance with Getinge Quality and Management System 4 Information regarding non critical features and attributes referenced are neither tested nor verified Non critical information and attributes are included only to improve equipment understanding for the user The FS is regarded as one of the most important documents for test reference during subsequent qual ification e g IQ OQ etc The categories are used in this document on individual requirements or on entire sections 2 1 3 3
82. y dangerous conditions must not be possible to do without meet ing the critical condition A stepped restarted or aborted process is regarded as failed in the process report The alarm is reset and the visual indication is turned off through a button press when the program is back in stand by Interlock alarms shall only be able to reset by authorized persons with activated authorization key Process Failure is printed in the end of the process report Failure Alarm List Power Failure the alarm is set if power returns after a loss with duration above 10 seconds I O Fault Alarm the communication between the CPU and a I O board is lost Emergency Stop Alarm the emergency stop is activated Analogue Input Failure Alarm this type of alarm is set if an analogue sensor is broken or out of range the alarm text is associated with the faulty sensor e g AI Fail Pressure AI Fail Jacket Steam Generator Error the water level is low or the steam generator 1s malfunctioning Door Failure the alarm is set if a door is not indicated to be closed during process Door Seal Failure the alarm is set if a door seal is not indicated to be pressurized during process Pressure Timeout this type of alarm is set if pressure increase in process exceeds a reasonable maxi mum time Sterile Timeout the alarm is set if the sterile timer has been halted for more than 5 min due to low temperature Vacuum Timeout the alarm is set if evacuation

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