PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method Steam sterilized 50 times forward and 50 times reverse for 30 minutes at 135 °C
Analysis Note
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature
Legal Information
Solvex is a trademark of Merck KGaA, Darmstadt, Germany
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