Sterility Testing by Direct Inoculation Method Direct Inoculation Method Learn the procedure for sterility test for sterile pharmaceutical products by direct inoculation method. 1.0 Objective : To lay down Standard Operating Procedure is to provide guidelines for sterility testing by Direct Inoculation Method. 2.0 Scope This procedure is applicable for the products manufactured at the location which can not be tested by Membrane Filtration Method. 3.0 Responsibility Implementation: Microbiologist 4.0 Accountability Execution: Manager - QC Review & Approval : AGM - QA / QC Procedure Direct Inoculation Method Sample for Finished Products: Collect the samples to be tested for sterility. Out of the whole sample, randomly select 20 articles of each lot of batch for both LVP and SVP t erminal 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 bot...
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