Wednesday, January 24, 2024

How to do environment monitoring of microbial load in Class D area in Solid oral dosage form in pharma manufacturing facility

·         Class D areas are considered controlled support areas with relatively lower cleanliness requirements compared to aseptic processing zones (Grade A/B/C). While they may not directly handle sterile materials, they can still impact the overall cleanliness of the manufacturing process.

·         Microbiological monitoring focuses on detecting and quantifying airborne microorganisms. Ideally, this should be done at rest, meaning when the area is unoccupied and equipment is inactive. This provides a baseline assessment of the inherent microbial contamination level of the environment itself.

·         During operation, activities like granulation and mixing generate significant air disturbances, leading to increased particulate counts. These particles can act as carriers for microorganisms, potentially elevating the microbial count in the working condition. So, solely relying on operational monitoring might not accurately reflect the true microbial state of the environment.

Therefore, conducting both at-rest and operational microbiological monitoring provides a more comprehensive picture:

·         At-rest monitoring: Identifies potential contamination sources within the environment itself, independent of process activities.

·         Operational monitoring: Assesses the combined impact of the environment and process activities on microbial contamination levels.

This combined approach allows for a more effective risk assessment and targeted interventions to control and minimize microbial contamination throughout the manufacturing process.


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