Stability Studies for Biocides
Biocidal products will either fall under the scope of BPR or national regulations. For manufacturers to exhibit product stability under certain conditions and to demonstrate product shelf life, it is a mandatory regulatory requirement to proceed to Stability testing for Biocides.
Biocidal Stability studies determine the physicochemical properties and active substance prior and after the study. QACS provides long term stability studies as well as accelerated storage tests.
CIPAC 46.3 describes the accelerated storage conditions which a product should undergo to support product stability for two years at ambient temperature. At QACS we store the product in increased temperature conditions, to predict the normal long-term ageing of the biocidal formulation. CIPAC data can be used to demonstrate that the product is likely to be stable for two years at ambient storage.
-Accelerated stability studies do not replace the need for ambient storage data which are necessary to confirm the ambient storage of a biocidal product.
The method is usable for solid and liquid formulations.
The ambient storage stability is complimentary to the accelerated as the outcome predicted from the accelerated is also proved in real time conditions. Key parameters are included in the protocol prior to, during and after the storage for the required shelf life of the product.
At QACS we investigate the effects of light, temperature, and humidity as part of the biocidal stability studies whenever it is necessary.
As far it concerns the packaging, the product must be stored in its final commercial packaging in order to assess both product stability and compatibility.
By using the test method CIPAC MT 39.3 we detect the sensitivity of liquid formulations at low temperatures.
*In case label instructions lead the user not to store the product under conditions of ≤ 0°C (e.g. a phrase like ‘protect from frost’) then proceeding to low temperature stability testing is not necessary.
For some formulation types the stability on freeze/thaw cycles may also be investigated.