Sterilization
We use a highly advanced Ethylene Oxide gas sterilizer that delivers precise moisture levels for effective sterilization, and utilizes minimum quantity of ethylene oxide gas that was easy to recover at the end of the cycle. This procedure has taken into consideration the very special hygroscopic nature of synthetic absorbable sutures which has the tendency to bond effectively with ethylene oxide in the presence of moisture thus they degenerate and lose strength on storage, leading to serious implications for the patient and the surgeon.
Precision & Reliability
- The sterilization process is validated according ISO 11135:2014/AMD 1:2018 “Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices”
- For routine monitoring purposes, the biological indicators are placed throughout the sterilizer load and subjected to the sterilization process. After the process, the biological indicators are removed from the load and forwarded to SURGIMEDIC testing laboratory, where they are placed into a special growth medium and subjected to ideal growth conditions for 7 days (as addressed in USP1). After the 7-day incubation period, negative growth of the biological indicators demonstrates that the sterilization process was effective. The sterilizer load may then be considered for release to market, provided all other release criteria are met.
- We are using biological indicators that comply with ISO 11138-2:2017 “Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes” and chemical indicators that comply with ISO 11140-1:2014 “Sterilization of health care products — Chemical indicators — Part 1: General requirements”.
