Validation Of An ETO Sterilization Cycle
To ensure the safety and efficacy of medical devices, 這 環氧乙烷 (排隊) 消毒 process must undergo a rigorous validation procedure. This process confirms that the equipment consistently delivers the required sterility assurance level (薩爾) for specific products.
1. Commissioning (IQ/OQ)
Ensures that the sterilization equipment maintains operational specifications and performs within the required parameters (溫度, pressure, 濕度) for your specific product items.
2. 業績資質 (質子Q)
Obtains and interprets documented evidence that the process consistently results in sterilized products that comply with predetermined specifications.
這 “過度殺戮” / Half-Cycle Method
In accordance with 國際標準化組織 11135, 生物指標 (BI) are used to challenge the cycle. The logic is as follows:
- 半週期: Demonstrates a 6-對數減少 of the most resistant microbiological challenge. Three successful half-cycle experiments are required.
- Full Cycle: By doubling the exposure time of a successful half-cycle, we provide a 12-對數減少, ensuring absolute product safety.
- Annual Revalidation: Performed yearly to confirm that process parameters remain effective.
Critical Testing for ETO Validation
Validating an EtO cycle requires more than just biological monitoring. Routine bioburden testing is essential to detect any changes in manufacturing, environment, or packaging. Essential tests include:
- Bioburden Monitoring
- Bioburden Validation (Recovery Efficiency)
- Sterility Testing
- Ethylene Oxide Residuals Testing
- Bacterial Endotoxin Test (BET)
- Bacteriostasis-Fungistasis Testing
Partner with BOCON for Seamless Validation
在博康, we don’t just provide 環氧乙烷滅菌器 (BCS系列); 我們提供技術專業知識來幫助您滿足監管要求. 我們的設備旨在提高智商, 氧氣質量, 和 PQ 流程, 確保您的設施已做好審核準備並符合國際標準.
