Manufacturing facility for production of sterile products
The 970m2 facility, on the ground floor of an existing building, consisted of a GMP/GDP compliant warehouse for the receipt and storage of raw materials, consumables, packaging components and shipment of finished products to approved distributors. It also incorporated a GMP cleanroom – divided into manufacturing, labelling and packaging areas – and a GMP Quality Control facility. The cleanrooms were classified as Grade C (production areas) and Grade D (transit areas).
There was a requirement for close control on temperature within both production area zones, with each zone including a Cold Room controlled to operate between +2˚C and +8˚C. The required refrigeration plant (for general HVAC requirements and for the Cold Rooms) was external to the facility. The fresh air AHU was also located outside the host building with ducting to the facility, as required
CRC was responsible for the development and execution of DQ, IQ and OQ documentation and protocols, alongside the client.
MicroPharm develops immunotherapy products to target infectious diseases and acute toxic conditions, including anti-venoms for the treatment of snakebites. All are designed to treat acute, life-threatening emergencies, have been developed at the request of the medical profession and are required urgently either because no alternative exists or because any alternative is ineffective and/or unsafe.
Contract Value: Circa £1.5 million