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Environmental testing for manufacturing facility – facility Air and manufacturing suites

Environmental Monitoring Services
Cleanroom & Manufacturing Facility Validation per ISO 14644/USP <1116>​

Overview Service

Capzer Pharmaceuticals delivers comprehensive environmental monitoring for pharmaceutical manufacturing facilities, including cleanrooms, controlled areas, and support zones. Our FDA/DEA-registered team performs on-site sampling and analysis to verify microbial and particulate control during commissioning, routine operations, and post-remediation.​

Our Approach

Sampling follows EU GMP Annex 1 and FDA aseptic guidance using active air (RCS samplers), settle plates, surface swabs/contact plates, and non-viable particle counters. Viable counts target <1 CFU/m³ (Grade A), with identification of isolates and trend analysis establishing alert/action limits for Contamination Control Strategy (CCS).​​

Key Capabilities

  • Airborne particulates (0.5/5.0 µm) and viable microorganisms per ISO 5–8 classifications.
  • Surface monitoring for workstations, equipment, and personnel gowns.
  • On-site collection or client-supplied samples with full incubation/enumeration reporting.​

Benefits for Partners

Partners maintain GMP compliance for Gabapentin and Empagliflozin production suites through our ISO 17025-accredited testing, supporting PAI readiness and preventing batch disposition delays from environmental excursions.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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