In this SOP we will explain the Aseptic Filling Process Validation Media Fill Trial. 1. PURPOSE To ensure that aseptic manufacturing, filling techniques or practices being used are capable of producing the sterile products. 2 .SCOPE It is applicable to the injectable area of the Production Department. 3. RESPONSIBILITY Quality Assurance officer Section Production Officer […]
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In this article, we will discuss the Clean Steam Validation procedure using in pharmaceutical sterile manufacturing. A sampling of Pure steam for Bacterial Endotoxin Testing & Viable Count Samples for Bacterial endotoxin evaluation should be collected in dehydrogenated tubes/bottles. Remove the cap from the bottle immediately prior to obtaining a sample. While samplings avoid direct […]
Continue ReadingIn this Sop, we will explain about Qualification Of Compressed Air And Nitrogen Gas in the Pharmaceutical Industry. 1. PURPOSE To write down the procedure to monitor compressed air/gases (Nitrogen)for microbiological, non-viable particulate, oil, and moisture 2. SCOPE This SOP is applicable for monitoring of compressed air and nitrogen gas in different production areas for […]
Continue Reading1 PURPOSE To ensure control over viable and non-viable count in the clean area. 2 SCOPE This procedure is applicable for a different part of all manufacturing areas of the sterile dosage form. (Injection section) 3 RESPONSIBILITY Microbiologist, Quality Control Manager, Section Supervisor, Production manager 4 Equipment/APPARATUS i) Nutrient Agar ii) Tryptone […]
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