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Cleanroom Design & Build
GMP cleanroom construction
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.
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Flush finishProjecting ledges kept to a minimum. |
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Centralised or decentralised air handlingA positive pressure HVAC system for air supply with terminal HEPA filtration. |
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ECO control systemDelivering advanced cleanroom monitoring & control. |
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Material transfer & airlocksTo provide physical separation and minimise microbial and particulate contamination. |
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Vision panelsTo 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 the newly released EU GMP Annex 1 — and guarantee the performance of the GMP rooms based on the parameters laid out in your URS.
Installation Qualification |
Operational Qualification |
Performance Qualification |
| Installation Qualification is a documented process that ensures the facility and equipment provide exactly what is required. |
Operational Qualification verifies that the installed facility and associated equipment operate in accordance with the design specifications. |
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. |
We will work closely with you to make sure you have everything you need for a successful inspection.
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:
- 11,000m² cleanroom in Cardiff for healthcare production
- 33-room manufacturing facility with 5 cleanrooms in Edinburgh for cell & gene therapy manufacture, and incorporates a training academy
- 80m² cleanroom in Cardiff for the aseptic filling of intravenous drugs
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