| Physical Performance Qualification (PPQ) • It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process. How many runs should the PPQ process perform? • To demonstrate process reproducibility, at least 3 runs are required; • If 3 half-cycles were run during the MPQ process, then at least 1 additional run with full exposure time shall be performed. |
Reference Standards:
- ISO 11135:2014 (Medical device EO sterilization validation)
- FDA Guidance (2007): Sterility Assurance for Terminal Sterilized Products
- EU GMP Annex 1 (2022): Sterilization process validation requirements.
How is Reproducibility Demonstrated?
| No. | Process Step | Item | Method |
|---|---|---|---|
| 1 | Preconditioning | Temperature and humidity of the sterilized load are within the specified range at the end of preconditioning | Measure inside the load |
| 2 | Loading | The time interval between the end of preconditioning and the start of sterilization should be within the specified range | Verify recorded time data |
| 3 | eo Sterilization | Ethylene oxide (EO) is introduced into the sterilizer in gaseous form | Measure gas injection temperature |
| 4 | eo Sterilization | Pressure increase due to EO gas injection is within the specified range | Measure pressure during gas injection |
| 5 | eo Sterilization | EO gas concentration inside the sterilizer is within the specified range | Weigh the gas canister before/after injection and calculate the differenceor directly measure gas concentration inside the chamber |
| 6 | eo Sterilization | Product temperature inside the load is within the specified range during the exposure phase | Measure product temperature |
| 7 | Aeration | Product temperature inside the load is within the specified range during the aeration phase | Measure product temperature |
When evaluating the execution of PPQ testing, the following aspects should be noted:
• Does the number of temperature and humidity probes meet requirements?
• Are the (temperature and humidity) probes placed inside the loaded packages and positioned at the worst-case locations (most difficult-to-sterilize positions)?
• Is the temperature of the product load within the specified range?
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