Clean Room Requalification Services

NHS Blood and Transplant (NHSBT) seeks a qualified supplier to perform Clean Room Requalification services for the Clinical Biotechnology Centre (CBC). The CBC is a specialist facility that manufactures plasmids and viral vectors for early-stage clinical trials targeting incurable diseases including cancer and genetic disorders. The facility requires comprehensive requalification of classified clean rooms used for manufacturing sterile products and tissues to ensure compliance with current GMP regulatory specifications outlined in EudraLex Volume 4 Annex 1. Services must include monitoring and classification of clean room environments, with minimum annual requalification cycles (At Rest), plus particle count assessments performed both At Rest and In Operation. The supplier must demonstrate expertise in pharmaceutical clean room classification, validation, and regulatory compliance with European GMP standards for sterile medicinal product manufacturing.