Pre-Validated EO Sterilization Cycle

Adopt QSTERILE, our QTS-owned, pre-validated ethylene oxide (EO) sterilization cycle to save time and money on your next project by not having to complete your own full EO sterilization validation. Normally a full EO cycle validation encompasses multiple half-cycle and full-cycle testing, incorporating biological indicators and temperature/humidity mapping, along with product-specific testing of microbial resistance and product EO residuals.

By utilizing the QSTERILE, cycle testing is already completed in accordance with ISO11135 requirements, and our customers are only required to perform product-specific testing to adopt into the cycle.

Included with QSTERILE:

• Sterilization of products utilizing the QTS pre-validated cycle
• Access to the Microbiological/Physical PQ reports
• Requalification of the sterilization cycle every two years (MPQ/PPQ)

Capacity constraints have become an issue in the medical device sterilization market, driven by increased scrutiny of EO emissions and supply issues with gamma sterilization. High concentration EO cycles used with the traditional half-cycle overkill approach have been historically popular due to its high validation success rate. However, the high volume of EO used can be problematic regarding emissions.

QSTERILE, on the other hand, reduces EO emissions by using the cycle calculation approach combined with a low concentration EO cycle. In addition to using less EO, it also helps to minimize cycle times. When you adopt QSTERILE it will mean fewer emissions and less stress on EO facility capacity, all while ensuring a safe and sterilized product.

At Cretex Medical | QTS, our sterilization experts designed QSTERILE to speed your products to market with confidence. Our proprietary pre-validated EO cycle is backed by rigorous testing, proven sterility assurance levels, and expert technical support, ensuring your devices are fully protected throughout their lifecycle. The sterilization facilities with whom we work have years of experience and a track record of excellence.

When you choose QSTERILE, we will manage the sterilization process for you. You will have peace of mind knowing that your products will reach market faster, more sustainably, and more cost-effectively.