What did our client need?
Our client provides a range of solutions to enable safe and reliable powder transfers within high-potency handling and sterile processing.
For the production of a newly developed product for the biopharma sector, we were appointed to build a new classified production area.
The product is a high integrity single use bag that reduces the risks associated with cross-contamination during powder transfers and eliminates the time and expense associated with cleaning and validation.
With an increasing implementation of transfer bags towards the mid-stream and the end of biopharma processes, some manufacturers are rescinding upstream filtration processes.
This means that effective quality control assuring low levels of particulate and bioburden contamination for powder transfer is critical to the entire process.
The new 80m² cleanroom facility was designed to support the client’s process by facilitating the flow of people and product, with separate transfer areas for materials and gowning.
Validated to ISO 14644-1, the main production area uses HEPA filtration to meet air changes and particle counts according to class 6 and the transfer areas meet class 7 requirements.
The air changes ensure the critical process has a constant supply of clean air. An energy-efficient level of air re-circulation for the processed air prevents the retention of particles in the room and manages operating costs.
Built with Quadcore insulated UltraTech Precision panels, the cleanroom envelope system has a flush-finish that is compatible with GMP guidelines on facility design.
Temperature control provides comfort cooling, contributing to the stable environment and compressed air terminals and power outlets, delivering services at the point they are required.
C2C was able to support the client’s wider contamination control strategy with a turnkey service, supplying specialist change room and workstation furniture, monitoring equipment and cleaning consumables.