clean steam

Clean Steam Validation

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 […]

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Clean Room Environmental Control

1   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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