Enhanced Chemical Analysis for Copper Sulphate
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 differ...
Buyer
NHS Blood and Transplant
Value
Not provided
Published
11 Feb 2021
Closes
11 Feb 2021
Procurement details
Source
Find a Tender
Region
United Kingdom
Procurement method
Not provided
Category
Services
Contract starts
Not provided
Contract ends
Not provided
CPV classifications
71900000
Laboratory services
Lots
Lot 1 Study 1 - Assessment of products useful life
Value not provided
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.
Delivery: United Kingdom
Lot 2 Study 2 - Assessment of the device’s stability during shelf life
Value not provided
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...
Delivery: United Kingdom
Lot 3 Study 3 - Bacterial contamination
Value not provided
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 challe...
Delivery: United Kingdom
Lot 4 Study 4 – Packaging
Value not provided
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)
Delivery: United Kingdom
Lot 5 Study 5 – Health and Safety
Value not provided
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
Delivery: United Kingdom
Lot 6 Study 6 – Impacts to Specific Gravity
Value not provided
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 rout...
Delivery: United Kingdom
Documents
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