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
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
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...
by Dr. Yashashwini Reddy | Aug 27, 2025
Importance of Microbiological Analysis in Cleaning Method Validation Cleaning Method Validation (CMV) is a critical component in pharmaceutical manufacturing to ensure that equipment is free from product residues, cleaning agents, and microbial contaminants before...
