STERILIZATION METHODS > ADDITIONAL INFORMATION

Batch Release

• For some medical devices in R&D, the product or package design is not yet frozen. In these instances, Boulder Sterilization can do a “batch” release per ISO 11135, Annex E, for a single-lot release.

EO Cycle Studies for Product and Packaging Evaluation

• A separate study to subject the product’s validated load configuration through two complete sterilization cycles (referred to as a “2X EO Process”) may be advantageous. This EO validation helps maintain inventory of your product by avoiding the need to discard expensive products in the event of an unforeseen occurrence.
• As the 2X EO process presents a greater challenge to the sterilization process, product functionality validation/verification, package integrity and EO/ECH residue testing are required.

Temperature and Humidity Monitoring

• Boulder Sterilization has calibrated data loggers to provide data on the product temperature and relative humidity during the EO sterilization process.