Stability Process

Stability testing involves two aspects:

1. Physical Stability Testing

Testing the physical characters, emulsion, colour, viscosity, odour and pH. Samples are testing initially and at regular intervals (Week 2, 4, 8, and 12) to see any changes and treats that occur overtime.

Samples are held under controlled temperature conditions of 4°C and 40°C and at room temperature 20°C +/- 5°C. Accelerated studies involve samples being held at raised temperature and being brought back to 20°C only at time of testing. The full accelerated study at 40°C takes 3 months and approximates to 1 year at 20°C. It is possible to run the rest protocol on for a further 3 months in order to derives an approximate shelf life of 2 years at 20°C etc.

2. Preservative Efficacy Testing

Microbial Preservative Testing:

Preservative efficacy testing (PET) is designed to show how well the product can withstand attack from micro-organisms.

Preservative efficacy testing involves inoculating a sample of the product with known quantities of known micro-organisms to see how the preservative system holds up. The sample is held at constant temperature and the micro-organisms are recounted after specific times to see the trend in the survival rate of the micro-organisms. This test is done with a range of micro-organisms and follows internationally approved testing procedures. The testing is performed at a NATA certified laboratory.

Please note that preservative efficacy testing is not a guarantee that the products will be preserved under all conditions. It gives a good indication, however of the products ability to withstand microbiological contamination under normal conditions. Many countries and markets are now requiring preservative testing before allowing these products to enter the marketplace. Please ensure you check this.

Please also note that a change of raw material supplier, raw materials, formula percentage or packaging means that the testing could be invalid and further testing will be required.