Sterility Testing Procedure Learn how to perform the test for sterility for sterile pharmaceutical products by Membrane Filtration Method. 1.0 Equipment Required Sterility Testing Procedure ¤ LAF ¤ Manifold holder assembly ¤ Vacuum pump ¤ Forceps ¤ Scissor 2.0 Material Required © Sample © Sterile 0.45ยต Membrane filter © Sterile FTM © Sterile SCDM © Sterile 0.1% w/v Peptone water © 70% sterile IPA Solution © Gas burner © Sterile Filtration assembly © Sterile SCDA plates © Sterile Swab 3.0 Utilities Required Vacuum Pump 4.0 Procedure: Membrane Filtration Method → Sample for Finished Products: Collect the samples to be tested for sterility as per SOP. Out of the whole sample, randomly select 20 articles (as per Pharmacopoeia) of each lot of batch for both LVP and SVP te rminal ly sterilized products and for aseptically filled products. → Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bottle pack machine (When c...
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