C2C details an ISO Class 7 cleanroom build for medical collagen

Connect 2 Cleanrooms has completed a 50 sqm GMP cleanroom designed in zones to facilitate CambCol’s process and equipment for milling and freezing

In 2020 Connect 2 Cleanrooms were chosen to build a 50 sqm project for a UK-based medical collagen company. CambCol has developed a range of high-quality, medical collagen products to provide benefits across a range of applications.

As CambCol are producing a medical-grade product, the specification of the cleanroom adhered to GMP design principles. With its Kingspan Precision panel system's fully flush envelope, the facility is future-proofed to meet emerging regulations.

C2C designed the cleanroom to have 70 air changes per hour at an air speed of 0.45 m/s in the main area.

"Using our reliable design process, we used digital modelling to calculate and verify the air flow design, reducing risk and enhancing performance. HEPA fan filter units (FFUs) were used to process and deliver the particulate control and the air change rate (ACR) required to achieve ISO 14644 Class 7," C2C said in a statement.

"Our ECO control system gives real-time visibility on the cleanroom's performance and alarms if any monitored parameters vary outside of a user-defined threshold," the statement explained.

The cleanroom was designed in zones to facilitate CambCol's process and equipment for milling and freezing. Some machinery was part enclosed, to control the heat gains within the classified areas and doors and vision panels were incorporated to facilitate process flow.

"We provided a full furniture fit-out service, coordinated with the cleanroom installation to reduce overall project lead times and benefitting CambCol with the opportunity to use a single point of supply," C2C explained.

Cleanroom validation was then performed to qualify performance in accordance with ISO 14644, with an interim report issued immediately and the full report to meet the needs of regulatory bodies issued in just 2 days.

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