Supply of a 68-Gallium Chloride Radiopharmaceutical Generator, Synthesis Unit and HPLC hardware and analytical software

The Radiopharmacy Department is a Pharmaceutical manufacturing unit, located within the Heritage Building at the Queen Elizabeth Hospital Birmingham. The Radiopharmacy Department has recently had a business case approved to bring PET imaging using 68-Gallium radiopharmaceuticals into the Trust. The requirement is for a synthesis unit, gallium generator and HPLC hardware and analytical software for QC testing.

Additional information: The Radiopharmacy Department is a Pharmaceutical manufacturing unit, located within the Heritage Building at the Queen Elizabeth Hospital Birmingham. The Radiopharmacy Department has recently had a business case approved to bring PET imaging using 68-Gallium radiopharmaceuticals into the Trust, increasing the Trust's diagnostic imaging portfolio. Production of 68-Gallium tracers requires the 68-Gallium to be eluted from a radionuclide generator. Radiochemistry then takes place in a synthesis unit to produce a range of injectable 68-Gallium based radiotracers. Finally Quality Control (QC) release of the produced radiotracer is required prior to patient administration. The scope of the procurement is for a synthesis module capable of synthesising the eluted 68-Gallium from a generator to a pharmaceutical product which meets the European Pharmacopeia (EP) Monograph, and is therefore safe for patient administration. In addition to a synthesis unit there are two additional requirements; I.Gallium Generator for the production of 68-Gallium Chloride II.HPLC hardware and analytical software for QC testing of the final product, to provide an assurance that the product meets the EP specification and is safe for patient administration. The tender response must also include as a separate line, details of installation and operational qualification (IQ/OQ) to be performed. The response must also detail training provision, technical support and warranty period with details of what is not covered under the warranty. The Maintenance Questionnaire attached requests quotes for 1, 3 and 5 year options. Accordingly the maximum term of the contract will be 5 years (60 months).