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Test Method & Conditions Standard:USP Sterility Tests / EP 2.6.1 Method:Membrane Filtration (0.45 m cellulose nitrate, Millipore HAWP) Rinse Solution:0.1% Peptone Water (Fluid A per USP), 3 100 mL per membrane Sample Size:35.1 mg dissolved in 10 mL sterile diluent, filtered through 2 membranes Media:FTM (Fluid Thioglycollate Medium) + SCDM (Soybean-Casein Digest Medium), BD Difco Environment:ISO Class 5 (Grade A) / ISO Class 7 background, P 15 Pa Incubators:Validated Memmert IN110 0.5C, IQ/OQ/PQ qualified, continuous temperature logging 2