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.