Pharmaceutical Cleanroom Installation
GMP Grade A–D | ISO 14644 | Filter Integrity Testing
Pharmaceutical and biotech manufacturers operate in some of the most tightly regulated cleanroom environments in the world. We deliver GMP-compliant cleanrooms to Annex 1 standards, with full validation documentation to support your regulatory submissions.
Standards & Compliance
- EU GMP Annex 1 — Manufacture of Sterile Medicinal Products
- ISO 14644-1:2015 — Cleanroom Classification by Particle Count
- ISO 14644-2 — Monitoring to provide evidence of cleanroom performance
- MHRA Good Manufacturing Practice guidelines
- FDA 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
- Filter integrity testing and airflow validation
Key Considerations
Contamination Control
Pharmaceutical cleanrooms demand stringent contamination control. We install airlocks, pass-throughs, and pressure cascade systems that prevent cross-contamination between zones.
Airflow Precision
Unidirectional (laminar) airflow is critical in Grade A zones. We design and install HVAC systems that deliver consistent airflow uniformity to the required specification.
Regulatory Validation
MHRA and FDA expect rigorous documented evidence. We carry out filter integrity testing and produce validation documentation to support your regulatory submissions and site inspections.
Cleanroom Classification
We carry out particle count testing to ISO 14644-1 in at-rest and in-operation conditions, providing certified classification data for your QA records.
Services We Provide
- GMP Grade A–D cleanroom installation
- ISO 5–ISO 8 environment build
- Filter integrity testing
- HEPA/ULPA filter installation and testing
- Airflow balancing and validation
- Commissioning and performance testing
- Pass-through and airlock installation