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
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...
by Dr. Yashashwini Reddy | Aug 27, 2025
Best Practices in Pharmaceutical Microbiology Laboratory Facility & Environment Maintain controlled cleanroom environments with appropriate classification (ISO/GMP requirements). Ensure unidirectional personnel and material flow to minimize contamination risk. Use...
by Dr. Yashashwini Reddy | Aug 27, 2025
🔹 Key Strategies to Strengthen Microbiological Control Raw Material Control Perform supplier qualification and audits. Conduct microbiological testing for bioburden and objectionable organisms. Establish strict acceptance criteria. Water System Management Validate and...
by Dr. Yashashwini Reddy | Aug 27, 2025
1. Contamination Risk Biggest challenge due to microbial, particulate, or endotoxin contamination. Can occur through personnel, raw materials, equipment, environment, or poor aseptic practices. Requires strict aseptic techniques, gowning, and environmental monitoring....
