Environmental Monitoring (Viable Monitoring) Limits as per Regulatory Requirements
Introduction Environmental Monitoring (EM) plays a crucial role in maintaining and verifying the aseptic conditions of pharmaceutical cleanrooms. Viable monitoring, a key part of EM, focuses on detecting and quantifying living microorganisms such as bacteria and fungi that could potentially contaminate sterile pharmaceutical products. Regulatory authorities such as USFDA, EU GMP, WHO, and ISO 14644 have established specific guidelines and limits for viable contamination in various cleanroom grades. These limits help ensure product sterility, patient safety, and compliance with Good Manufacturing Practices (GMP). Types of Environmental Monitoring Environmental Monitoring is broadly classified into: Non-viable monitoring – Measurement of airborne particulate matter using particle counters. Viable monitoring – Detection of living microorganisms using culture-based methods. Viable Monitoring Methods Viable monitoring methods are used to identify microbial contamina...