Sterility test for Parenterals

Sterility test for Parenterals

1. Purpose It is established to ensure the Sterility test for Parenterals. 2. Scope It is applicable in the microbiology department of the Quality Control laboratory. 3. Responsibility Microbiologist Quality Control Manager 4. Introduction About Sterility test for Parenterals The following procedures are applicable for determining whether an article purporting to be sterile complies with […]

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bacterial endotoxin test

Bacterial Endotoxin Test Procedure

1. PURPOSE It is established to learn bacterial endotoxin test procedure, to ensure that endotoxins are within the limits of parenteral preparations 2. SCOPE It is applicable in the microbiology department of the Quality Control laboratory. 3. RESPONSIBILITY Microbiologist Quality Control Manager 4. INTRODUCTION Pyrogen was defined by Webster as a “fever producing agent”. If […]

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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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