Radiotherapy devices and supplies

Tender description

Supply of a 68-Gallium Chloride Radio-pharmaceutical Generator, Synthesis Unit and HPLC hardware and analytical software. The Radio-pharmacy Department is a Pharmaceutical manufacturing unit, located within the Heritage Building at the Queen Elizabeth Hospital Birmingham. The Radio-pharmacy Department has recently had a business case approved to bring PET imaging using 68-Gallium radio-pharmaceuticals 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 radio-tracers. Finally Quality Control (QC) release of the produced radio-tracer 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 2 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).