3.4.1.1生產過程挑戰設備（PCD）
過程挑戰設備（PCD）是用於評估選定過程參數的殺戮率的微生物挑戰系統。它通常是包含生物學指標的設備或測試套件（例如，具有已知孢子計數的芽孢桿菌孢子）。 PCD對滅菌過程的電阻應大於或等於產品最難殺傷區域的天然微生物載荷的電阻。 PCD的數量應滿足GB18279.1-2015中附錄C的表C.3中概述的要求。 PCD分為內部PCD（IPCD）和外部PCD（EPCD）。
a）內部PCD（IPCD）生產
內部PCD通常是公司選擇代表產品系列的醫療設備。基於設計和材料組成，這些產品被認為是最難消毒的一些產品。生物學指標（BI）放置在產品最難降低的位置，以確保滅菌過程不會阻止通道或乾擾產品設計。
將生物學指標（BI）放置在產品最難以殺傷的區域，或接種測試微生物（例如，阿特羅氏桿菌）在具有最難達到的無滅菌狀態的位置，如果BI或測試微生物最難放置在同一設備中，則可以將其放置在同一設備中，以至於將其放置在較難的位置，以至於較難的設備，以至於將其放置在較難的位置，以至於較難的位置，以至於較難的位置，以至於將其置於較難的範圍內，以至於將其放置在較難的設備中產品中最困難的位置。
常見的IPCD包括但不限於：
將受污染的載體放置在戒指，活塞頭，墊圈或註射器活塞等組件之間。將微生物挑戰放置在導管腔內的微生物挑戰，然後使用導管重新密封的粘合劑溶劑或連接器來重新密封導管並恢復產品的完整性。將微生物的挑戰放置在piston互換處。
b）外部PCD（EPCD）生產
外部PCD放置在加載產品的外部。 EPCD通常用於常規處理，並在處理後從負載中檢索。應將EPCD對滅菌產品生物負荷的電阻與IPCD的抗性進行比較。 EPCD還應代表負載中最難殺死的產品。
應定期審查EPCD與受污染的產品樣品之間的關係，以確保在滅菌產品中沒有發生任何變化，並且EPCD仍然代表了負載中最難以抗化的產品。
將BI放置在PCD中時，PCD至少應具有與產品中最難刺激的位置相同的電阻。
常見的EPCD包括但不限於：
將生物學指標（BI）放置在產品包裝或等效的內部，例如塑料袋，然後將其放置在馬尼拉信封內部。將生物學指示劑放置在厚塑料袋中，該塑料袋已折疊了指定數量的次數。將生物學指標置於注射器的各個部分，例如在Piston asher shoder或Piston的塑料中，不包括塑料型塑料。
以上述方式生產的PCD使用與常規生產產品相同的方法包裝，該方法均勻分佈在產品負載中，並定位為覆蓋滅菌室內的冷點。
3.4.1.2部分週期（短週期）測試
選擇PCD後，通過運行部分週期來確認其適用性。評估方法如下：
a）根據操作評估的結果確定PCD，測試樣品和傳感器的放置方法。 PCD的數量和分佈應該足夠。如果所選的EPCD用於常規滅菌過程監測，則應根據計劃和程序將其放在產品負載上。
b）基於生物學指標的D值，ST時間和KT時間，設置了一個較短的暴露時間。其他參數應在常規滅菌過程參數的下限下進行測試。測試方法應參考GB18281.2的附錄A。暴露時間結束後，刪除產品，IPCD和EPCD進行微生物培養，並觀察結果。
培養結果應表明，PCD的耐藥性大於或等於產品中最困難的位置的生物負荷耐藥性：
IPCD和EPCD應部分為負；完全負或完全積極的結果將表明測試失敗。 IPCD的電阻應大於產品，並且EPCD的電阻應大於或等於IPCD的電阻。
如果結果不符合期望，請調查原因。通常，需要對PCD電阻或滅菌參數進行調整，然後重新測試，直到結果與期望保持一致為止。如果所有三個（產品，IPCD和EPCD）都沒有微生物的生長，請適當地減少EO暴露時間並再次測試。如果所有人都表現出微生物的生長，請增加EO暴露時間和重新測試。
3.4.1.3半週期測試
成功完成短週期測試後，進行了三個連續的一致半程測試，以證明EO滅菌過程的有效性（SAL = 10^-6）和可重複性。評估方法如下：
Set the biological indicator’s sterility as the standard, and set other sterilization process parameters to the lower limit of routine sterilization parameters (e.g., pre-treatment transfer time within the specified range). Gradually halve the sterilization exposure time of the initial sterilization process and remove biological indicators from the PCD after different sterilization times. Cultivate them in a sterile environment until sterility is confirmed. The shortest sterilization time (critical time) thus determined will be the half-cycle time, and at least two more tests should be conducted with the same shortest time.
All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1×10^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.
The biological indicator cultivation results should show all IPCDs and EPCDs negative. If the short-cycle test shows that the EPCD’s resistance is greater than that of the IPCD, the EPCD may show partial positivity.
If the results do not meet expectations, investigate the cause and usually adjust the sterilization parameters before retesting until the results align with expectations.
Example:
Assume the first half-cycle sterilization exposure time is 4 hours. If sterile, reduce the exposure time to 2 hours for the next test; if microbial growth occurs, increase the exposure time based on the 4-hour exposure.
Assume the second half-cycle sterilization exposure time is 2 hours. If sterile, reduce the exposure time to 1 hour for the next test; if microbial growth occurs, extend the exposure time to 3 hours.
Assume the third half-cycle sterilization exposure time is 3 hours. If sterile, repeat the 3-hour test twice. If all results are sterile, confirm 3 hours as the minimum effective time. If microbial growth occurs, repeat the test with 4-hour exposure, and if all results are sterile, confirm 4 hours as the minimum effective time.
3.4.1.4 Full Cycle Testing
During full cycle testing, set the EO exposure time to twice the half-cycle minimum effective time, and other parameters to the upper limit of routine sterilization parameters to verify the reliability and reproducibility of the sterilization process.
The number of temperature and humidity sensors used should meet the requirements of Appendix C in GB18279.1, evenly distributed within the sterilization load. Temperature sensor placement points should include both the cold and hot spots within the sterilizer chamber during the Operational Qualification (OQ).
After the test, the cultivation results of the product and EPCD should show complete sterility (all negative).
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| ISO 11135:2014 | Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices |
|---|---|
| ISO 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods – Part 1: Determination of a population of microorganisms on products |
| ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| AAMI TIR16:2017 | Microbiological aspects of ethylene oxide sterilization |