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 Connect 2 Cleanrooms can help.
GMP cleanroom manufacturers
GMP cleanroom construction principles reduce particulate and cross-contamination risks for pharmaceutical production. We have extensive experience working with companies such as the NHS to deliver GMP compliant manufacturing facilities.
Take a look at the ways we can custom-build your perfect GMP room.
Flush finish
Centralised or decentralised air handling
ECO control system
Material transfer & airlocks
Vision panels
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.
We will work closely with you to make sure you have everything you need for a successful 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.
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. Take a look at some of the GMP projects we have completed below.
BioCube cell & gene therapy suite for RoslinCT - GMP Grades B, C & D
Industry: Healthcare | Pharmaceutical
Wall type: Monobloc – fully flush
Classification: GMP grade B / C / D
A sterile manufacturing cleanroom facility for the NHS - GMP grades B, C & D
Industry: Healthcare
Wall type: Monobloc – fully flush
Classification: GMP grade B / C / D
Cytiva supports global biopharma industry with 6,000m² cleanrooms in Cardiff, Wales
Industry: Healthcare
Wall type: Monobloc – fully flush
Classification: ISO 7
Start a project with us
Our design and build specialists have experience working with customers in all kinds of industries on a global scale, achieving great results time and time again. We’d love to work with you as well!