by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for performing microbiological integrity testing of sealed vials to ensure container closure integrity and sterility assurance. 2. Scope This SOP applies to all finished sterile product vials manufactured in the facility that...
by Dr. Yashashwini Reddy | May 3, 2025
In a sterile facility, especially in industries like pharmaceuticals, biotechnology, or medical device manufacturing, maintaining a controlled environment is crucial for ensuring product safety and preventing contamination. One key component in maintaining sterility...
by Dr. Yashashwini Reddy | Nov 27, 2024
Q1. Why is microbiology important in the pharmaceutical industry? A: Microbiology ensures that pharmaceutical products are free from microbial contamination. It plays a crucial role in sterility testing, microbial limit testing, and environmental monitoring to...
by Dr. Yashashwini Reddy | Nov 1, 2024
Disinfectant Validation in the Pharmaceutical Industry In the highly regulated world of pharmaceuticals, maintaining clean and sterile environments is essential to ensure product safety and quality. Disinfectant validation plays a critical role in this process,...
by Dr. Yashashwini Reddy | Oct 18, 2024
Injectable In-Process Quality Assurance (IPQA) Department: A Key to Quality Injectable Manufacturing Injectable products play a critical role in healthcare by delivering medications directly into the bloodstream, ensuring quick action. The manufacturing of these...
