ChargePoint Technology provide a range of solutions to enable safe and reliable powder transfers within high-potent and sterile processing. For the production of a newly developed ChargeBag for the biopharma sector, it appointed cleanroom specialist Connect 2 Cleanrooms (C2C) to build a new classified production area at its manufacturing facility in Liverpool.
ChargeBag PE-S 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 midstream 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.
"When working in the biopharma sector, control needs to be stringent. We've invested heavily in the development and validation of the film and bag manufacturing processes. We wanted to house the production in the best possible area we could to meet the regulatory requirements of the industry," said Emerson Mulvaney, Director of Engineering and Operations at ChargePoint Technology.
The new 80 sqm cleanroom facility was designed to support ChargePoint Technology's process by facilitating the flow of people and product, with separate transfer areas for materials and gowning.
Validated to ISO 14644-1:2015, 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 Kingspan Quadcore insulated 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 ChargePoint Technology's wider contamination control strategy with a turnkey service, supplying specialist change room and workstation furniture, monitoring equipment and cleaning consumables.
