SCI Cleanroom Cleaning 2025/26

Description

The Cellular and Molecular Therapies (CMT) function is a Specialist Services department forming part of NHS Blood and Transplant (NHSBT) Therapeutic Services. The laboratories process, store and distribute human cell based products and gene therapies for transplantation and other therapies. CMT consists of seven laboratories based within NHSBT facilities at Barnsley, Birmingham, Filton (Bristol), Liverpool, Oxford and Southampton. Currently, these laboratories require scheduled and adhoc deep cleans of their clean rooms, with frequencies detailed in Appendix 1. Each laboratory operates clean room facilities in accordance with EUGMP (Annex 1) requirements and is licensed by the Human Tissue Authority (HTA) in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Joint Accreditation Committee - ISCT and EBMT (JACIE). The activities of the NHSBT CMT stem cell processing laboratories involve processing, testing, storage and distribution of human progenitor cells for autologous and/or allogeneic transplantation. Liverpool, Barnsley, CBC, Birmingham and Filton laboratories are also regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) for cell and gene therapy medicinal product manufacture. A high level of hygiene and cleanliness is essential to preventing contamination and maintaining the sterility of these products. Additional information: A pre-market engagement meeting will take place early 2026, all interested parties will receive an on-line invite.