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GMP-Ready Sterile Facilities, From Design to Certification

The Challenge

Pharmaceutical cleanrooms live or die by regulatory compliance. A failed inspection means production stops. You need a partner who understands EU GMP Annex 1, unidirectional airflow, pressure cascades and the documentation your inspector will ask for — before you're asked.

What We Deliver

Sterile fill-finish suites (Grade A/B with Grade B background)
Bulk and sterile API production areas (Grade C/D)
QC laboratories and microbiology labs
Cleaning and disinfection-ready envelopes (coved corners, flush fixtures)
Personnel and material airlocks, air showers, pass-through chambers
Complete validation: IQ/OQ/PQ, airflow visualization, particle counts, filter integrity tests

Key Technical Capabilities

Cleanliness	ISO Class 5–8 / GMP Grade A–D
Air changes	Designed to your process and local code
Documentation	Full package for EU GMP / FDA / WHO inspections