Low Temperature Sterilisation ISO 14937 Validation and Performance Jon Mulhall Senior Validation Engineer ASP Johnson & Johnson Medical 27 th March 2018
What is ISO 14937? A (very) brief history.. In the 90 s there were only standards for steam and ETO sterilizers and nothing for the new generation of sterilizers including low temperature using hydrogen peroxide or ozone for example. In 2001 the ISO committee Click developed to edit Master a subtitle generic style standard for validation that wasn t specific to any technology. 2 2
What is ISO 14937? A (very) brief definition.. ISO 14937 is a generic standard about the requirements to achieve the sterility of medical devices based on a quality management system. No details are given about parameters to measure or how to proceed as there would be with steam for example. Open to interpretation Compliance to this standard is a process which involves the sterilizer manufacturer, the medical device manufacturer and the healthcare facility. Its not a one time process, it s a daily process and should be defined and applied by the healthcare facility. It could include. Procedure to release the load Procedure for the routine control and monitoring of the sterilization process Procedure to maintain the effectiveness of the sterilization process Procedure for the requalification of the sterilizer May involve the validation of other systems associated with the process. I.e. BI incubator or heat sealer. THE VALIDATION OF GAS PLASMA LOW TEMPERATURE STERILIZERS IN COMPLIANCE WITH THE ISO 14937 STANDARD REINFORCES THE QUALITY ASSURANCE IN STERILIZATION. 3 3
What is ISO 14937? Structure and responsibility.. 1. Application field 2. Normative reprimands 3. Definitions 4. Quality system 5. Sterilizing agent characterization 6. Process / equipment characterization 7. Product definition 8. Process definition 9. Validation 10. Routine control and monitoring 11. Product release from sterilization 12. Maintaining process effectiveness Under the responsibility of the manufacturers Under the responsibility of the healthcare facility with support from MDMs 4 4
Pressure Torr What is ISO 14937? How its applied to STERRAD.. 59% H 2 O 2 Injected 760 Inlet valve closed 180 22 6 H 2 O Removed Orifice closed H 2 O 2 to chamber 24 48 5 Concentration Transfer Diffusion Plasma Time Vent 5
Cycle Stages (repeated twice) Warm up start Injection pump down Injection Vapourization pump down Chamber pump down Transfer Pressure check Diffusion Plasma pump down Plasma Vent 6 6
Cycle parameters measured Temperatures - Chamber front 50 C 47 C ~ 56 C - Chamber centre 50 C 47 C ~ 56 C - Chamber rear 50 C 47 C ~ 56 C - Input Door front 50 C 47 C ~ 56 C - Output door rear 50 C 47 C ~ 56 C - Condenser 35 C 30 C ~ 40 C - Vapourizer 75 C 60 C ~ 80 C Pressure - Chamber Hi 0 Torr ~ 1000 Torr - Chamber Lo 0 Torr ~ 30 Torr - Vapourizer 0 Torr ~ 30 Torr 7 Plasma 500W 450W ~ 550W 7
8 Validation process Calibration and verification - Verification of measuring devices used during the validation process (data logger etc) - System and IMS Temperature calibration and verification - System and IMS pressure calibration and verification - System and IMS plasma power verification - System and IMS time verification - H 2 O 2 Monitor calibration. Operation Qualification - Complete cycles (2 injections) for each cycle installed on STERRAD. Performance Qualification - Three half cycles for each cycle installed using a standard test load. Alarm Conditions - Verification of door sensor safety device. - User cycle cancellation - Power failure cancellation 8
Cycle parameters. 9 9
Typical OQ cycle 10 10
Typical OQ cycle 11 11
Typical challenge pack used for PQ testing 12 12
Typical PQ cycle 13 13
14 Documentation of the validation process Profile of the STERRAD Reference to Technical Dossier that was supplied with the STERRAD. Validation procedure Validation report (IQ/OQ/PQ) Appendix A Calibration certificates and product certification forms. Appendix B Alarm condition tests. Appendix C Operational Qualification (OQ) cycle parameters and recorded graphs. Appendix D - Performance Qualifications (PQ) recorded graphs. Appendix E IFU / Calibration procedures / drawing of the load position within the chamber. History of validation List of materials and documents General information about the healthcare facility. 14
Example of the effect of the load.. 15 15
Vapourization pump down The time taken to complete the vapourization pump down phase is a good indication of the overall condition of the STERRAD. 16 16
Future developments.. Being able to provide the validation report in electronic format. 17 17
Q & A 18 18