Enhanced Chemical Analysis for Copper Sulphate

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.

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.

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.

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)

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

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