SCI Clean Room Cleaning

Tender description

NHSBT requires deep cleaning services for laboratories within The Stem Cells and Immunotherapies (SCI) function which 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 for transplantation and other therapies. SCI consists of seven stem cell processing laboratories based within NHSBT facilities at Birmingham, Bristol, Leeds, Liverpool, Oxford, Sheffield and Southampton. Currently, six of these laboratories (Birmingham, Bristol, Leeds, Oxford, Sheffield and Southampton) require 6 monthly, deep clean of their ISO 14644 grade 5 designed clean rooms. Each laboratory operates clean room facilities in accordance with EUGMP Grade A /B 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 SCI processing laboratories involve processing, testing, storage and distribution of human progenitor cells for autologous and/or allogeneic transplantation. Birmingham and Bristol laboratories are also regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) for cell therapy medicinal product manufacture. A high level of hygiene and cleanliness is essential to preventing contamination and maintaining the sterility of these products. Periodic, specialist Deep Cleaning is required, supplemental to in-house cleaning and disinfection regimes to ensure that the interior of the SCI Cleanrooms are maintained in a sufficient state of cleanliness in order to achieve EUGMP Grade A/B standards as required by the regulatory authorities. The quality of the cleaning service is significant to the effective running of NHSBT operations and its compliance with the standards expected by MHRA, HTA and JACIE. It is imperative therefore that the specification standards for this service are consistently achieved.The Supplier will be expected to have, or be working towards, Quality Management System BSI (EN) ISO 9001 or equivalent.