Supply of Copper Sulphate Solution for Blood Donor Haemoglobin Screening

Descriptions

1. General Requirements - Background:

Prior to accepting whole blood and platelet donors for donation, NHS Blood and Transplant (NHSBT) screen the donor's haemoglobin levels to ensure the donor meets the appropriate acceptance criteria as set by Blood Safety and Quality Regulations (BSQR). The primary process for donor haemoglobin screening is the use of a Copper Sulphate gravimetric test which must ensure that donors with haemoglobin concentrations of less than 135g/L for male donors and 125g/L for female donors are not accepted for blood donation.

2. Requirement:

NHSBT's Blood Supply directorate are seeking a contract for the sub-manufacture of two copper sulphate, semi-quantitative reagents for in vitro investigation of donor haemoglobin levels to determine suitability for blood donation. NHSBT Reagents are the legal manufacturer under the UK Medical Devices Regulations (UK MDR 2002, as amended) of the two solutions and shall maintain this position throughout the duration of the contract.

As a general overview, the contracted sub-manufacturer of the two solutions will be responsible for:

a) Sourcing and maintaining supply of raw materials and consumables as per NHSBTs product specification.

b) Manufacturing the bulk solution as per NHSBTs product specification.

c) Quality Control testing solution, to be evidenced with certificate of analysis.

d) Decanting and labelling the final bulk solution into the end stage universal containers as per NHSBTs product specification.

e) The packaging, storage and transportation of the final product to NHSBTs 3 warehouses - located in Filton, Warrington and Borehamwood.

f) Support NHSBT in supply of samples and data for evaluation and investigation purposes to support continued compliance with the UK MDR 2002.

g) Maintain retention samples of bulk and final product as per NHSBTs product specification.

An official product specification will be supplied as part of the invitation to tender (ITT) stage.

3. Volume

The annual volume required per solution (Male & Female) is approximately 4,000 Litres, which equates to 160,000 x 25mL containers of each product. To manage expiry dates and operational lead times the supplier will propose batch sizes to NHSBT. The current expiry date of the product is 5 months from the date of initial manufacture.

4. Specific Gravity

The specific gravity of the products is set as 1.053 (range 1.0528 - 1.0532) for female donors and 1.055 (range1.0548 - 1.0552) for male donors.

5. Contract Duration

The contract duration is still under consideration. The current assumption is 3 years plus 2 x 1 year options. The estimated contract values are based on 5 years.