| Qualificazione di Prestazione Fisica (PPQ) • Hè deve esse dimustratu chì tutti i criterii d'accettazione specificati sò riproducibili in tuttu u prucessu. Quante corse deve esse realizatu u prucessu PPQ? • Per dimustrà a riproducibilità di u prucessu, almenu 3 runs sò necessarii; • Se 3 half-cycles sò stati eseguiti durante u prucessu MPQ, almenu 1 run supplementu cù u tempu d'esposizione sanu deve esse realizatu. |
Norme di riferimentu:
- ISO 11135: 2014 (Validazione di sterilizazione EO di i dispositi medichi)
- Guida FDA (2007): Assicuranza di sterilità per i prudutti sterilizzati terminali
- UE GMP Annex 1 (2022): Esigenze di validazione di u prucessu di sterilizazione.
Cumu si dimostra a riproducibilità?
| Innò. | Passu di prucessu | Articulu | Metudu |
|---|---|---|---|
| 1 | Precondizionamentu | 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 differenceo 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 | Aerazione | 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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