Stability Testing

Stability Testing

Every product placed on the UK or EU market must be stability tested under “reasonably foreseeable storage conditions” to establish that no separation, crystallization, contamination, degradation or other instability occurs. Stability testing covers changes in appearance, colour, odour, pH, viscosity, density, pack performance etc.

At MSL Solution Providers, we are pleased to be able to offer a wide variety of Conditions. We generally break down our Conditions into 3 suites (A-C) as we find this suits most clients’ needs. However, bespoke packages and extra conditions can easily be added as required. All of our stability packages are designed to be able to assign a maximum of three years shelf life, although an extended shelf life (i.e. up to five years) can be predicted in certain circumstances.

In addition to stability testing, we can also offer pack performance and compatibility testing. This includes investigation into the effects of various conditions on the final packaging, for example, loosening of cap wads, exfoliation/peel of labels, corrosion/stress cracking of containers, swelling of dip tubes, inadequate barrier properties of packaging etc. These are designed specifically for each product depending upon individual product requirements.

The Stability Testing Conditions offered include:

• Temperature variations (from -18°C to 60°C) – Constant and Cycling. Temperature cycling from very low to ambient or higher temperature is the condition where preservative issues are usually picked up or are likely to fail. Consideration should be given to the transport and storage conditions of the products (Temperate, Mediterranean/Subtropical, Hot & Dry, Hot & Humid).

• Fade Lamp (Ambient) – Daylight / Store light simulation (we can meet the lighting requirements of the Boots, M&S, and supermarket standards, as well as UV light testing). We have bulbs for D65, F840, P15, TL83 and UV, with capacity to add additional bulbs as required.

• High Humidity – Consideration should be given to the location of manufacture, shipping conditions and anticipated storage of the products for example, in a domestic bathroom.

• 22 degrees (Dark) – This condition is usually used as the Reference Standard to which all other conditions are compared.

For more information about our stability testing service, please contact us.