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The process provides an alternative to the sterilization of cartridges and vials with ethylene oxide (EtO).
Because of their sensitive nature, many biologics cannot be terminally sterilized in glass containers with the use of steam. Historically, these types of products have been sterilized using ethylene oxide; however, “the rapid rise in biological drug development is expanding the market for new sterilization techniques that can overcome the current limitations of current methods,” according to Andrea Zambon, product manager of EZ-fill vials and cartridges at Ompi.
A press release from Ompi warns that EtO sterilization should only be used for pharmaceutical products that cannot support conventional high-temperature steam sterilization, and due to EtO’s structure, it is considered a reactive compound that could stoke immunogenicity in patients, said the release.
Ompi’s new steam sterilization process is designed to differ from traditional steam sterilization methods, offering an alternative to sterilization for biological products that does not rely on the use of EtO.