Mostafa Eissa
Environmental monitoring performance analysis: a comparative study of class c and class d controlled environments
Journal title : Universal Journal of Pharmaceutical Research
Publisher : Society of Pharmaceutical Tecnocrats
Print ISSN : 2831-5235
411 Views Original Article
Monitoring and controlling of clean area environment is of paramount importance to ensure product safety and quality. This comprehensive analysis evaluates environmental monitoring (EM) data from Class C and Class D controlled environments in pharmaceutical manufacturing, utilizing Active Air (AA), Passive Air (PA), and Contact Plate (CP) or Replicate Organism Detection And Counting (RODAC) surface samples. The study aims to identify contamination trends, anomalies, and compliance with ISO 14644-1 and EU GMP Annex 1 standards. Results reveal unexpected findings: Class C Active Air (43 CFU/m³) and RODAC (3 CFU/plate) overall averages are higher than Class D Active Air (34 CFU/m³) and RODAC (2 CFU/plate), respectively, deviating from expected cleanroom classification. Class D Passive Air (22 CFU/plate) is higher than Class C (17 CFU/plate), aligning with expectations. Persistent hotspots were identified in Class C (e.g., location labelled “AA C 12 NG0”AA averages± Standard Deviation (SD): 67.33±17 CFU/m³), indicating localized control failures, while Class D showed extreme individual spikes (e.g., AA D 99 Ac: Max 171 CFU/m³). Sporadic contamination events in Class C suggest transient breaches, necessitating root-cause investigations. The study also highlights limitations of Class D monitoring, which obscures temporal trends and risks missing critical excursions due to long intervals between samples. Recommendations include targeted engineering assessments for high-load zones, enhanced Standard Operating Procedures (SOPs) for cleaning and gowning, adoption of real-time biofluorescent particle counters to replace manual sampling, and increased monitoring frequency in Class D hotspots.
Article DOI & Crossmark Data
DOI : https://doi.org/10.22270/ujpr.v10i4.1397
Article Subject Details
Article Keywords Details
- contact plate sample
- contamination control
- ISO 14644
- Active air sampling
- Environmental monitoring
- Pharmaceutical manufacturing
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