What is it about?

This research compares microbial contamination levels in two different grades of pharmaceutical manufacturing environments: the stricter Class C and the less stringent Class D. It analyzes air and surface samples to check compliance with standards and identify unexpected trends or control failures.

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Why is it important?

Counterintuitively, the analysis found that the supposedly cleaner Class C rooms had higher average microbial counts in the air and on surfaces than the less-clean Class D rooms. This finding challenges the assumption that a higher classification always equals a cleaner environment in practice. It highlights that effective control depends on continuous, data-driven monitoring rather than just the room's official designation.

Perspectives

This study uses a comparative benchmarking perspective. It evaluates and compares the performance of two different cleanroom classifications (Class C and Class D) against each other and against established standards. The main goal is to verify if these controlled environments are performing as expected. The perspective was validated when it uncovered the unexpected finding that the supposedly cleaner Class C room had higher average contamination levels than the Class D room, challenging the assumed cleanliness hierarchy and highlighting a potential breakdown in control protocols.

Independent Researcher & Consultant Mostafa Essam Eissa

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This page is a summary of: ENVIRONMENTAL MONITORING PERFORMANCE ANALYSIS: A COMPARATIVE STUDY OF CLASS C AND CLASS D CONTROLLED ENVIRONMENTS, Universal Journal of Pharmaceutical Research, September 2025, Society of Pharmaceutical Tecnocrats,
DOI: 10.22270/ujpr.v10i4.1397.
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