Co-located Aseptic and Radiopharmacy Modular Unit at Singleton Hospital Swansea

Descriptions

The ABMU Health Board requires a newly constructed and fully equipped co-located modular Aseptic and Radiopharmacy facility at Singleton Hospital, with a developable footprint limited to 480 m2.It is intended to use the new facility for Aseptic/Radiopharmacy preparation of “Section 10” exempt medicines and manufacture of medicines under a MHRA “specials” licence – this includes; Centralised Intravenous Additive Services (CIVAS); Chemotherapy Medicines, and: Parental Nutrition (TPN) solutions.The facility needs to comply with the latest regulations in terms of build and services including GMP to ensure the correct level of facility build quality. It must be designed and commissioned to comply with specifications laid down in the relevant standards governing room types including laboratories, clean rooms and general areas, and for specific user requirements where more stringent standards are requested.The new facility will be licensed by the Medicines & Healthcare products Regulatory Agency (MHRA) as a manufacturing unit for “special” and must be compliant with appropriate MHRA, Health Building note (HBN) & Welsh Health Technical Memorandum (WHTM) and design requirements.