Total Clean Air recently delivered a GMP-compliant cleanroom for a new dedicated HTA-licensed cell biobanking facility, meeting Human Tissue Authority requirements on an accelerated eight-week timeline.
Total Clean Air
The modular approach enabled rapid deployment within an existing building while maintaining regulatory standards. It demonstrates how pressure on timelines is reshaping cleanroom design and build strategies.
Northern Ireland's first cell storage and biobanking facility launched in July 2026, offering cryogenic and ultra-low temperature storage to support life sciences, healthcare and research organisations across Northern Ireland and the Republic of Ireland.
The launch was dependent on the rapid delivery of a controlled environment capable of supporting highly regulated operations, necessitating an accelerated cleanroom delivery. The facility marks a significant step forward for life sciences infrastructure in the region, filling a gap in critical new infrastructure not previously available in the locality.
Catherine King, CEO & Founder, LifeCellsNI, had been working on the idea for the company since 2015, when she first identified a gap in the market for local storage of cells and stem cells.
King said: “I contacted Total Clean Air, specialists in cleanroom design and manufacture. I’d been following their work for a while, and I knew they had the experience, compliance and speed we required. I remember contacting them in the run up to Christmas and saying: we need a GMP cleanroom very quickly – can you help?”
Nick Ridgment, sales director at TCA, continues: “That’s right. I contacted you straight away! I think we were taking deposit payments on the day we finished for Christmas. Between us we very quickly devised the precise User Requirement Specification (URS). We were on site with the GMP Grade D / ISO Class 8 cleanroom just 8 weeks later!”
“One of the areas that defines TCA as a company is our speed of response. We pick up enquiries and we run with them very quickly. If we hadn’t been able to offer the guaranteed eight-week timeline, LifeCellsNI wouldn’t have been able to keep to their project plan.”
Not only was the timeline tight, but the requirement was also far more stringent than typical cleanroom companies could accommodate, involving a solution for the region’s first human-to-host licence, meeting Human Tissue Authority (HTA) requirements.
Total Clean Air fully managed the project, including design, management, build, installation, commissioning and certification to ISO 14464, the international standard for cleanrooms, as well as user training and handover.
King said: “TCA delivered speedily, as promised, and everything was kept to such a high standard. It was faultless!”
The start-up secured £590,000 in pre-seed funding in March 2026, accelerating development of the regulated cryogenic storage and processing hub.
Following the launch in summer 2026, LifeCellsNI has ambitious plans to cater for life science needs across Northern Ireland and Ireland but also to invite users from mainland UK and from Europe.
“With the HTA licence on track to be obtained by the end of the summer, LifeCellsNI will look at MHRA status also allowing the facility to be used for cell therapy, for cancer and diabetes research, CAR-T therapy to drive forward personalised medicine in Northern Ireland,” King explains.
HTA licence along with MHRA status down the line will allow LifeCellsNI to move into clinical trials to allow companies from the UK and Europe to use the facilities.
With stem cells and personalised medicine, the cells stored will ultimately go back into the patient from whom they were collected, whether for cancer treatment, spinal injury recovery or other advanced therapies.
“The material has to be treated within the highest specification for sterility. It will be used in a Grade A environment, then stored, and then used again for future treatments,” notes King.
“We’re working with biotech companies, pharmaceutical organisations, universities and health trusts that want to store samples or use the cleanroom. We can also rent the lab for short periods and really drive forwards innovation in Northern Ireland.”
Demand is already building, and the organisation is planning to add further cleanroom capacity, laboratory space and storage facilities as requirements grow.
LifeCellsNI is based in a former barracks building in Northern Ireland, making a modular solution the ideal approach for the available space. Total Clean Air’s Monobloc Protech Cleanroom solution was installed in February 2026, covering a total controlled volume of 59.58m3.
King said: “We had looked into modular cleanrooms and knew this option would allow us to have our cleanroom within the facility, especially with the critical tissues and cells we’re dealing with. I wanted everything in one place, under the one roof. It feels so much safer, the security is there.”
With demand for fast-track clinical and biotech facilities rising, this project highlights a growing shift towards agile delivery models for cleanrooms and highlights how speed and flexibility are becoming increasingly critical in life sciences infrastructure.
Designed to minimise contamination risk and maintain stable processing conditions, the facility operates at a target temperature of 21°C, supported by a dedicated Total Clean Air-designed HVAC system with integrated dehumidification. The strategy uses treated air drawn from the adjacent laboratory, providing an efficient solution tailored to the facility's exacting operational requirements.
The cleanroom was designed to support consistent laboratory processes, giving researchers and laboratory staff access to an environment focused on efficiency and control. Critical equipment is integrated seamlessly into the layout, while personnel and material flows have been carefully considered. Environmental systems operate unobtrusively in the background, supporting day-to-day activities without creating unnecessary complexity.
King concludes: “Beyond the health sciences sector, we have other industries very interested in using the facility, such as engineering companies looking to use it for microchip production and research. We’re in talks with a host of different industries interested in using the cleanroom because there’s nothing like that here.”
Phillip Godden, CEO of Total Clean Air, summarises: “The work Catherine and the LifeCellsNI team are undertaking embodies our ethos of creating ‘Incredible Spaces for Incredible People’. This facility is the first of its kind in Northern Ireland, helping to drive innovative science and directly benefitting people with cancers, neurological conditions, degenerative illnesses and more.”