My company is in discussion with a vendor regarding the SAL requirements for sterile gowning during aseptic filling in a Class A area. My understanding is that EU requirements only accept 10-6 for SAL, anyone who can provide a reference document for EU it is much appreciated. In the US it seems to be a bit more complicated in that the FDA allows some flexibility for 10-3 or 10-6. (ISO11137-2:2013). I am curious what other aseptic manufacturers are requiring from their gown suppliers and the rationale used?
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Gwendolyn Lohr
QA Regulatory & Compliance Specialist
Novo Nordisk Pharmaceutical Industries, LP
3612 Powhatan Road
Clayton NC 27527
USA
919 274 7383 (mobile)
gwwa@novonordisk.com
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