by Dr. Yashashwini Reddy | Aug 27, 2025
Elimination of Microbial Contamination from Classified Areas 1. Root Cause Identification Before elimination, identify why contamination occurred: Breach in personnel gowning or behavior. Ineffective cleaning/sanitization. HEPA filter leakage or improper airflow....
by Dr. Yashashwini Reddy | Aug 27, 2025
Data Integrity in Microbial Analysis 1. Introduction In microbiology laboratories (especially in pharmaceutical QC/QA), data integrity ensures that all results of microbial testing are accurate, complete, consistent, and trustworthy throughout their lifecycle. Since...
by Dr. Yashashwini Reddy | Aug 27, 2025
Reynolds Number and Its Significance in Purified Water System 1. What is Reynolds Number? Reynolds number (Re) is a dimensionless number that predicts the flow regime of a fluid (laminar, transitional, or turbulent). Formula: ...
by Dr. Yashashwini Reddy | Aug 27, 2025
Media Fill Test — Sterile API Manufacturing (Aseptic Process Simulation) 1. Objective To demonstrate that the aseptic API manufacturing process (including personnel, equipment, materials, and environment) can reliably produce a sterile product by simulating routine...
by Dr. Yashashwini Reddy | Aug 27, 2025
Validation of Fumigation in Cleanroom Area Fumigation in pharmaceutical cleanrooms is an essential process to control microbial contamination and maintain aseptic conditions. It involves the use of chemical agents (commonly formaldehyde, hydrogen peroxide vapor, or...
