Enhanced Chemical Analysis for Copper Sulphate

Tender description

NHSBT are seeking an enhanced analysis of Copper Sulphate solution which is an in vitro, semi-quantitative reagent used for investigation on the acceptance of blood donor minimum haemoglobin levels when taken from a capillary blood sample. The reagent is used to test a droplet of blood from a donor’s finger, following the use of a lancet, which will be transferred into the solution using a pipette. NHSBT must update the product conformity profile for this device and must understand the impact when exposed to different variables throughout its formulation process, transportation, use and storage. The profile is to be produced through a number of studies for visual, chemical and therapeutic analysis. In current practice, NHSBT Copper Sulphate solutions are used professionally for male and female specific testing to ensure only suitable donors are bled. Therefore, all studies must be conducted for scenario 1) Female Donation and Scenario 2) Male Donation. Lot 1: Study 1 - Assessment of products useful life Study 1 - Assessment of products useful life This is to be determined through the maximum number of drops of blood that can be added to the copper sulphate before the product returns an inaccurate result under varying conditions. Lot 2: Study 2 - Assessment of the device’s stability during shelf life Study 2 - Assessment of the device’s stability during shelf life During routine storage at what point does the device start to fail: (a) Visually (i) Photostability storage study (ii) Integrity of the labels when exposed to routine use, light. (b) Chemically (i) Chemical analysis storage study (ii)Theoretical analysis of formula to outline potential chemical interactions that may degrade over time. Lot 3: Study 3 - Bacterial contamination Study 3 - Bacterial contamination (a) During routine storage, at what point does bacterial ingress occur – Bacterial storage study to be conducted on fresh and end of shelf life product. (b) If the product is challenged with routine environmental microbiological contaminants does this result in proliferation of the contaminants? - Controlled bacterial challenge study conducted on fresh and end of shelf life product. Lot 4: Study 4 – Packaging Study 4 – Packaging Study to challenge the packaging to address the impact and potential for: (a) Product leakage (b) Product damage – Physical and degradation of the bottles and or seal (c) Product evaporation (d) Electrostatic impacts (from packaging material) Lot 5: Study 5 – Health and Safety Study 5 – Health and Safety Health and safety evaluation in accordance with Directive: (a) Risk to individuals (b) Appropriate method of discard (c) Shipping and Transportation recommendations Lot 6: Study 6 – Impacts to Specific Gravity Study 6 – Impacts to Specific Gravity Assessment of the impact of temperature on the specific gravity of the device: (a) Theoretical analysis of the device to calculate in the potential changes in Specific gravity that could occur under routine storage conditions (b) Study protocol to test the male and female device for specific gravity under a range of routine storage temperatures and in use parameters