Case studies

Cytiva supports global biopharma industry with 6,000m² cleanrooms in Cardiff, Wales

Cleanroom Design & Build

Key facts

6,000m² cleanroom manufacturing facility

For biopharmaceutical products, built across 3 phases

Phase 1 built in 9 months

On-site management team maintained a consistent presence on-site

ISO Class 7

With elements of GMP qualification, through DQ, IQ, OQ, and PQ

Integrates quality with performance

Temperature and humidity control, flush envelopes, air showers, vision panels, swipe card entry, and intercom systems

The client

Global life sciences company Cytiva has opened an 11,000m² manufacturing facility in Cardiff, Wales. As part of a two-year £1.1bn global expansion plan, the site manufactures mixer bags, flow kits, and tubing assemblies. These technologies are used in the development and production of biopharmaceuticals such as COVID-19 vaccines.

The project

Within this new facility, we built an ISO Class 7 cleanroom covering over 6,000m². The project was split across 3 phases and the speed of delivery was a key factor in our appointment. We were on-site within 3 months, and phase 1 was built in 9 months.

Our installation team is based strategically across the country, however, to support the ambitious delivery schedule we opted to recruit locally. This allowed us to develop a significant presence on-site, and reduce travel time to increase marginal gains. It also created skills in the local area, which is aligned with Cytiva’s values.

Our site management team maintained a consistent presence on-site, coordinating and supervising construction workers and ensuring construction and site safety. The cleanrooms at Cytiva are validated to ISO Class 7 and feature elements of GMP cleanroom qualification, through DQ, IQ, OQ, and PQ.

The cleanrooms

With flush envelopes, air showers, integrated vision panels, swipe card entry, and intercom systems, the cleanrooms integrate quality with performance. The bright and open environment creates completely open spaces for equipment layouts, giving Cytiva total flexibility to optimise the process flow.

The HVAC system controls temperature and humidity with terminal HEPA filtration providing particulate control with 99.99% efficiency at 0.3 microns. Air return columns withdraw air from 4 sides, so when any heat or particulate is generated from processes, they are pulled straight out of the room.

Joe Govier, CEO of Connect 2 Cleanrooms, said: “Drawing on our 20 years of experience, our team has designed, built, and validated the cleanrooms in Cardiff. The drive for this project was qualification and scale. This work ultimately advances and accelerates biotherapeutics and it’s been a pleasure to work with Cytiva on this high-profile project.”

When fully operational, the site will help to increase Cytiva’s global manufacturing capacity for single-use products by 20%.

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