Non-Viable Particle Monitoring
Measuring non-viable particles during aseptic operations is very critical and provides an instant status of the aseptic environment,…
Viable Particle Monitoring in Cleanrooms
Once a cleanroom facility is qualified, a routine environmental monitoring program must be designed, which includes identifying sampling…
Validating Depyrogenation Process: Meeting Ph. Eur. 5.1.12 Guidelines
In pharmaceutical manufacturing, particularly for parenteral preparations, equipment and primary packaging materials must be free from pyrogens. Pyrogens,…
Terminal Sterilization vs. Aseptic Manufacturing
Sterile pharmaceutical products must be free from microbial contamination to ensure patient safety. The sterility of the product…
Pharmaceutical Equipment Qualification: From URS to Routine Usage
In any pharmaceutical industry, purchasing equipment is not just about selecting a machine and using it. It’s a systematic process that involves several steps.
