Guide
GMP cleanrooms for pharma, medtech and biotech
GMP cleanrooms demand more than a particle count: microbiological control, traceable documentation and routines that hold up under inspection. We build facilities that meet the full picture.
What separates a GMP cleanroom from a standard ISO cleanroom?
An ISO-classified cleanroom is mainly controlled on particles. A GMP cleanroom is also controlled on microbiological load, and the regulation sets requirements on design, routines, training and documentation – not only on measured values.
Requirements on particle counts at rest and in operation plus microbiological limits.
Clear zoning with personnel and material airlocks.
Surfaces and details that can be fully cleaned and disinfected.
Qualification to IQ, OQ and PQ with traceable documentation.
Grades A–D and how they map to ISO classes
EU GMP Annex 1 uses grades A to D. Grade A is the cleanest zone for aseptic high-risk steps and corresponds roughly to ISO 5, grade B is the background environment around zone A, grade C sits around ISO 7–8 and grade D covers less critical steps, roughly ISO 8.
Industries we build for
We build GMP-adapted facilities for pharmaceutical manufacturing, ATMP and cell therapy, medical devices under MDR, biotech and laboratories – often in existing premises with ongoing operations.
From requirements to an approved facility
We work alongside your quality department from URS and risk analysis, through design and construction, to qualification, validation and a service agreement that keeps the facility inspection-ready.
Planning a GMP cleanroom?
Tell us about your process and requirements and we will come back with a suggested classification, layout and budget price.