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
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
Principle and Working of Autoclave 1. Principle The autoclave works on the principle of moist heat sterilization using saturated steam under pressure. When pressure is applied to water, its boiling point increases. At 121 °C (15 psi / 1.05 kg/cm² above atmospheric...
by Dr. Yashashwini Reddy | Aug 27, 2025
Purified Water Storage and Distribution System in Pharmaceuticals Purified water is a critical utility in pharmaceutical manufacturing, widely used in formulations, cleaning, rinsing, and as a raw material. A robust storage and distribution system ensures that water...
by Dr. Yashashwini Reddy | Aug 18, 2025
📋 Procedure for Sampling in Process Validation 1. Preparation Stage Review the approved Process Validation Protocol for sampling details (points, number of samples, method). Ensure that sampling tools and containers are clean, calibrated, and labeled. Train personnel...
