Low Temperature Sterilisation – ISO 14937

Validation and Performance

Jon Mulhall

Senior Validation Engineer

ASP Johnson & Johnson Medical

27th March 2018

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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 developed a generic standard for validation that wasn’t specific to any technology.

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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.

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What is ISO 14937 ? Structure and responsibility…..

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Under the responsibility of the manufacturers

Under the responsibility of the healthcare facility with support from MDMs

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

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What is ISO 14937 ? How its applied to STERRAD…..

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Time

Concentration Transfer

H2O

Removed

Pre

ssure

Torr

180

760

6

48 24

H2O2 to

chamber

Diffusion Plasma Vent

22

Orifice closed

59% H2O2

Injected

Inlet valve

closed

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What is ISO 14937 ? How its applied to STERRAD…..

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

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What is ISO 14937 ? How its applied to STERRAD…..

● 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

● Plasma

500W 450W ~ 550W

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Cycle parameters measured

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What is ISO 14937 ? How its applied to STERRAD…..

●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

- H2O2 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

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Validation process

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What is ISO 14937 ? How its applied to STERRAD…..

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Cycle parameters.

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What is ISO 14937 ? How its applied to STERRAD…..

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Typical OQ cycle

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Typical OQ cycle

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Typical challenge pack used for PQ testing

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Typical PQ cycle

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What is ISO 14937 ? How its applied to STERRAD…..

●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

Documentation of the validation process

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What is ISO 14937 ? How its applied to STERRAD…..

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Example of the effect of the load…..

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Vapourization pump down

The time taken to complete the vapourization pump down phase is a good indication of the overall condition of the STERRAD.

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What is ISO 14937 ? How its applied to STERRAD…..

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Future developments…..

Being able to provide the validation report in electronic format.

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What is ISO 14937 ? How its applied to STERRAD…..

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Q & A