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Particulate Matter Testing
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1993 The United agar Amebocyte Lysate Test ampuls antibiotic aseptic technique assay automated Autoskan bacterial batch biological clean closure container contents Coulter Counter culture media depyrogenation detection determined dilution dose Drug Assoc drug products endotoxin environment equipment EU/ml evaluation filtered water fluid GFOV gram negative HEPA HIAC Horseshoe Crab incubation injection intravenous LAL reagent LAL test large-volume parenterals leakage rates light obscuration Limulus amebocyte lysate Limulus test liquid manufacturers measured medium membrane filter membrane filtration microbial microorganisms microscope monitoring number of particles package integrity Parenteral Drug parenteral products parenteral solutions particle count particulate matter Pharm pharmaceutical Pharmacopeial Convention pressure quality control rabbit test rejected Rights Reserved rinse sensitivity sensor small-volume specific standard sterility test surface syringe Table Tech temperature test method test procedure test sample tion tube United States Pharmacopeial vacuum validation vials volume workbench