GMP Project

Sharp Clinical Cleanroom

Bespoke Design & Build

Medical Device GMP Project

The Challenge

ISO Class 7 Cleanroom

In the fast-paced world of medical device manufacturing, creating ISO Class 7 cleanrooms with a quick turnaround presents significant challenges. For this project, the client required an "Open Barn" configuration alongside a close-coupled control HVAC solution, all to be delivered within an extraordinarily short timeframe. This setup was essential for the production of lateral flow devices, a critical component in various diagnostic and medical applications.

The Solution

Rapid Assembly

To meet these rigorous demands, TCA undertook a full turnkey project, assuming full main contractor responsibilities. The solution involved an innovative approach to design and construction that enabled the rapid assembly and integration of the required cleanroom features. TCA's ability to deliver a comprehensive service—from initial design through to final implementation—was crucial. Their strategic planning and execution ensured that all components, including the specialised HVAC system, were installed and fully operational within the stipulated 16 weeks from the contract signing.

The Results

Optimal Conditions

The project's completion was a resounding success, culminating in the on-time and on-budget delivery of the cleanrooms. The client principle at Sharp Clinical, praised TCA's professionalism and effectiveness. Highlighting the team's exceptional performance from the initial communications to the project's completion, stating, "The team here at Sharp Clinical were all delighted to work with TCA, they were professional and excelled from our initial communications all the way through to completion – I have no hesitation in recommending TCA for cleanroom projects.” This project not only met but exceeded client expectations, reinforcing TCA’s reputation as a leader in cleanroom construction for the medical device industry.

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