Ethylene oxide (EO) is a widely accepted form of sterilization for medical devices that are sensitive to radiation or heat.
Batch release sterilization is ideal for medical device manufactures whose devices are very specialized and expensive to produce – devices that are not in the final device or packaging configuration where conducting a full EO sterilization validation would be impractical.
Batch release sterilization is an efficient way to obtain small quantities of devices that are deemed suitable for human use regardless of the design or production phase of the device. Batch release sterilization can produce many sterile products for human use or as little as one single device depending on the need.
Batch release sterilization is performed under the guidelines of ANSI/AAMI/ISO 11135-1:2007 and AAMI TIR 16 method described in ISO 11135 Annex B. This allows for quick turn-around times (TAT) and the release of devices suitable for human use typically in less than 5 to 6 weeks. The number of devices required for testing is small (however, other variables may result in the need to consume additional devices).
Once the device is in its final configuration, cycle development testing can be performed to validate a process challenge device and bioburden resistance testing. Thus reducing the number of devices needed for testing and reducing the TAT to 3 to 4 weeks.
Data generated during a batch release sterilization can be leveraged into a full validation with a couple of simple additions to the process. This allows for the production of sterile human use products with each phase of the validation process.