In April 2018, the Medicines and Healthcare Products Regulatory Agency issued a statement regarding the sterilization of direct and indirect product contact items within isolators*. Specifically, the organization addressed the use of hydrogen peroxide vapor (VPHP) for the sterilization of direct and indirect parts and process’ overall fragility. The agency mentioned how VPHP can fail due to very minor occlusions, with even the fatty acids from a fingerprint are able to shield organisms from VPHP. The position paper built on this by considering that some product contact parts (both direct and indirect) are designed in such a way that makes it difficult for hydrogen peroxide vapor to penetrate them thoroughly. They conclude that their stance is such that hydrogen peroxide vapor cannot be used to sterilize critical items. The MHRA then states that their expectation is that contact parts are sterilized using a robust sterilization method that meets the current requirements of Annex 1 of the EU and PIC/X GMPS for the manufacture of sterile medicinal products. They describe a robust sterilization method as one that “reaches all of the critical surfaces in a consistent and repeatable manner.”
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Isolator Decontamination and
Comparing CD Gas vs. Hydrogen Peroxide Vapor taking place over the next few weeks.
*They define indirect product contact parts as those that come into contact with items and components which do contact the product (i.e stoppers). Direct contact parts are those that the product passes through, such as pumps and filling needles.
