Determining the shelf life of chemical products such as aerosols and solutions is a complex process that involves a variety of tests and analyses. These tests are crucial to ensure the safety and efficacy of the products over the entire storage period.
Here is an overview of the common methods and procedures:
1. Stability studies
Long-term studies:
Products are observed and analysed over a set period of time under normal storage conditions according to specified intervals. These tests can last from months to years and aim to simulate real storage conditions.
Accelerated studies:
Products are stored under extreme conditions, such as elevated temperatures and humidity levels, to accelerate the normal ageing processes. These tests help to recognise possible changes more quickly and allow predictions to be made about long-term stability.
2. Physical and chemical analyses
Active ingredient content:
Regular measurements of the active ingredient content ensure that the concentration of active components remains within the specified limits.
pH value:
The pH value can change over time and thus influence the stability and effectiveness of the product. Regular pH measurements are therefore essential.
Viscosity:
The viscosity of solutions can be an indicator of changes in the composition or quality of the product. Consistent viscosity is important for applicability and efficacy.
3. Specific tests for aerosols
Spray behaviour (specific tests for aerosols):
The spray behaviour of aerosols is tested to ensure that the particle size and distribution remain constant over time.
Pressure measurements (specific tests for aerosols):
The internal pressure of the can is measured regularly to ensure that the aerosol content is delivered correctly and that there are no leaks.
4. Microbiological tests (can be carried out by one of our external network partners)
Products, especially aqueous solutions, are regularly tested for microbiological contamination. The presence of bacteria or fungi can jeopardise the safety of the product.
5. Sensory tests such as odour and appearance
An altered odour or appearance can indicate chemical changes and thus lead to product instability.
6. Packaging integrity
The integrity of the packaging is checked regularly to ensure that the product remains protected from external influences such as light, air and moisture.
Conclusion
Testing the shelf life of chemical products requires a comprehensive and systematic approach. Through a combination of long-term and accelerated stability studies, as well as physical, chemical and microbiological analyses, manufacturers can ensure the safety and efficacy of their products throughout their entire shelf life.
These rigorous tests are critical not only for regulatory compliance, but also for consumer confidence in product quality.
BioGenius recognises the importance of these all-encompassing tests down to the smallest detail and this is also reflected in our purpose statement: because we ensure permanently effective and protective products that enable people around the world to live safer lives.
If you are interested in testing your product for long-term stability, whether for registration under GLP or for internal purposes under non-GLP, please ask for a quote.
YOUR COMPETENT TEST INSTITUTE.
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