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Q: How are products sterilized?

A: Proterial does not currently provide device sterilization. We do however manufacture all of our products in a 13485:2016 registered facility that has a class 8 clean room for secondary operations and assembly. In addition, we use medical grade materials and 13485 standard procedures that keep our operation clean and efficient. Many OEMs work directly with bulk sterilization services that manage only that aspect of the project. Because sterilization is so critical to providing a safe and reliable product to the hospitals and patients, this process is generally outsourced to a specialist or done within the hospital itself. The optimal sterilization process for a given device is determined by materials, shelf life, quality, and the application requirements of the device. Typical sterilization procedures are: Chemical wipe down, autoclave sterilization, Gamma (Cobalt 60 radiation) sterilization, EtO (ethylene oxide) sterilization and electron beam irradiated (E-Beam) sterilization.

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