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Custom-built GMP Cleanrooms
Patient safety is critical in pharmaceutical manufacturing. This is why our GMP cleanrooms are fully compliant with Good Manufacturing Practice guidelines and the provided User Requirement Specification (URS). If you need an MHRA-compliant manufacturing environment, find out how the experts at Angstrom Technology can help…
GMP cleanroom manufacturers
GMP cleanroom construction principles reduce particulate and cross-contamination risks for pharmaceutical production. Each GMP cleanroom project has oversight from our dedicated Regulatory Governance team. This team has over 30 years’ combined experience in GMP & pharmaceutical industries and will work closely with you on the design, build, and validation processes.
Take a look at the ways we can custom-build your perfect GMP room.
Flush finish
Projecting ledges kept to a minimum
Centralised or decentralised air handling
A positive pressure HVAC system for air supply with terminal HEPA filtration
BMS Management system and EMS Monitoring system
Delivering advanced cleanroom monitoring & control
Material transfer & airlocks
To provide physical separation and minimise microbial and particulate contamination
Vision panels
To permit observation of production activities from outside the Grade A zone and Grade B area
GMP cleanroom qualification
Our GMP cleanroom qualification process meets EU GMP Annex 15 requirements. It covers Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and where necessary Performance Qualification (PQ).
Design Qualification will demonstrate and document the compliance of the design of your facility with GMP and your URS. We will integrate current applicable regulatory requirements — including where applicable EU GMP Annex 1 and guarantee the performance of the GMP rooms based on the parameters required by the regulations and laid out in your URS.
We will work closely with you to make sure you have everything you need for a successful initial regulatory inspection.
Installation qualification
Installation Qualification is a documented process that ensures the facility and equipment provide exactly what is required.
Operational qualification
Operational Qualification verifies that the installed facility and associated equipment operate in accordance with the design specifications.
Performance qualification
Performance Qualification verifies that the facility and associated equipment operate as intended under load in accordance with the design specification in a worst case scenario.
Meet our Regulatory Governance team
Joan Benson - Global Compliance and Quality Assurance Manager
Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.
GMP cleanroom design & build projects
Our complete systems are qualified to EU GMP or international cGMP, and also the required ISO classification. Not only that, but they can also meet any applicable international engineering and building standards and regulations.
We’ve developed proven envelope solutions and reliable cleanroom HVAC designs for many applications. As part of the Angstrom Technology group of companies, we pride ourselves on our in-house expertise and our capability to deliver over 100 cleanrooms every year across the UK, Europe and America. Including:
- 33-room manufacturing facility with 5 cleanrooms in Edinburgh for cell & gene therapy manufacture, and incorporates a training academy
- 80m² cleanroom in Newport, S Walesfor the aseptic filling of intravenous drugs
- 6,000m² cleanroom in Cardiff for healthcare production
GMP Validation & Compliance Support
Designing a GMP cleanroom requires precision and regulatory expertise. Let our specialists guide you through validation, documentation, and compliance requirements.
Frequently Asked Questions
A GMP cleanroom is a controlled environment designed, built, and operated to Good Manufacturing Practice requirements for the manufacture of medicinal products. In the UK and EU, sterile manufacturing is governed by EU GMP Annex 1, which sets limits for airborne particles and microbial contamination across four cleanroom grades.
Grade A is the highest standard, used for high-risk operations such as aseptic filling. Grade B provides the background environment for Grade A zones in aseptic preparation. Grades C and D are used for less critical stages of manufacturing. Each grade has defined limits for particle and microbial levels, both “at rest” and “in operation
ISO 14644-1 classifies cleanrooms by airborne particle concentration only. GMP goes further, adding microbial limits, limits for both at-rest and in-operation states, and requirements for documentation, monitoring, and qualification. A GMP cleanroom will meet an equivalent ISO class, but an ISO cleanroom will not automatically meet GMP requirements.
Every GMP project starts with your User Requirement Specification (URS). From there, we design pressure cascades, personnel and material flows, and surface finishes appropriate to each grade, with gowning and transfer arrangements to suit your process. The design is then formally checked against your URS through Design Qualification before construction begins.
Yes. We provide cleanroom validation covering Installation, Operational, and Performance Qualification, along with the documentation you need for regulatory inspections. We can also carry out routine requalification, which Annex 1 requires at least every 6 months for Grades A and B and at least every 12 months for Grades C and D.