NHS Blood and Transplant (NHSBT) have a requirement for Clean Room Requalification.
The Clinical Biotechnology Centre (CBC) at NHS Blood and Transplant (NHSBT) is a specialist facility that manufactures plasmids and viral vectors for early-stage clinical trials targeting incurable diseases like cancer and genetic disorders.
Operating as part of NHSBT’s Cellular and Molecular Therapies function, the CBC supports the UK life sciences sector by translating laboratory research into clinical-grade therapies.
The manufacture of sterile products or tissues should be carried out in clean areas, entry to which is through change rooms/air locks/transfer hatches for personnel/equipment and materials.
These classified environments MUST be monitored and achieve the appropriate current GMP regulatory specifications for that environment as detailed in EudraLex volume 4 “The rules governing medicinal products in the European Union” Annex 1 Manufacture of sterile medicinal products.
Classification and Re-qualification is performed at a minimum annually At Rest, except for particle counts which are performed At Rest and In Operation.