Please note NHSBT will only purchase against this framework agreement if the Department of Health mandate that Prion Reduction is to be implemented. Suppliers are asked not to make any product prior to conformation from NHSBT.
This tender is for Prion Removal System to be used during the processing of blood or components within the UK Blood Services. The term prion removal system is used to denote the consumables (packs and filters) and any associated equipment that is a necessary part of the process for prion protein removal. Manufacturers must have a proven track record in a similar environment to the UK Blood Services and the system must have been fully validated by the Service and accepted as fit for purpose. The consumables and any associated equipment must be CE marked. Certificated evidence from a regulatory body must be provided. The system must be compatible for use with blood collected into any manufacturers primary collection system. Blood products derived from the process must comply with the specification for existing blood products as described in the current edition of the Guidelines for the Blood Transfusion Services in the UK. Prion filtration systems may be incorporated into individual pack manufacturers blood collection systems, however there will also be a requirement for prion removal filters also to be available as stand-alone devices suitable for sterile connection to blood components produced from other manufacturers collection systems.