Environmental Monitoring Integration

Case Study: HVAC Failure Detected via Microbial Spike

Case Study: HVAC Failure Detected via Microbial Spike Case Study: HVAC Failure Detected via Microbial Spike This article details a progressive step-by-step tutorial on the validation lifecycle concerning a case study of HVAC failure detected via microbial spike. The primary…

Integration of HVAC Data into QMS and CPV Systems

Integration of HVAC Data into QMS and CPV Systems Integration of HVAC Data into QMS and CPV Systems The integration of Heating, Ventilation, and Air Conditioning (HVAC) data into Quality Management Systems (QMS) and Continued Process Verification (CPV) systems is…

Frequency and Type of Environmental Monitoring Required

Frequency and Type of Environmental Monitoring Required Frequency and Type of Environmental Monitoring Required Environmental monitoring (EM) is an essential component of pharmaceutical manufacturing, particularly in sterile and cleanroom facilities. It ensures that the environment is maintained within defined parameters,…

How to Document and Investigate HVAC-Related Excursions

How to Document and Investigate HVAC-Related Excursions How to Document and Investigate HVAC-Related Excursions In the pharmaceutical industry, the sterile environment is crucial for the integrity and quality of products. HVAC systems play a vital role in maintaining these conditions.…

Trending HVAC Parameters to Predict Contamination Events

Trending HVAC Parameters to Predict Contamination Events Trending HVAC Parameters to Predict Contamination Events The pharmaceutical industry faces stringent regulatory guidelines to ensure product quality and patient safety. One of the critical components within this framework is effective HVAC systems,…

Microbial Recovery Limits Based on Cleanroom Grades

Microbial Recovery Limits Based on Cleanroom Grades Microbial Recovery Limits Based on Cleanroom Grades In the pharmaceutical and biotechnology industries, ensuring the integrity and sterility of products is of utmost importance. One crucial aspect influencing this integrity is the microbial…