Stability Test Chamber and the basic know-how.
How to select a Stability Test Chamber?
To be able to rate and select the stability test chamber appropriately, one needs to understand what a stability test chamber actually does. And how is it relatable with respect to various components or ingredients that are essential to the products you manufacture and where do these products get used. In this article, we will try and help provide examples and tips to consider while selecting a stability test chamber.
What is a Stability Test Chamber?
Most Stability Test Chambers resemble a huge scientific refrigerator. The only difference is, instead of only keeping the content cool, stability test chambers replicate variations in temperature, humidity and light over longer periods of time. This is imperative when it comes to pharmaceutical companies, especially when they want to bring new products to the market. It has a lot to do with the recommended shelf life when it comes to a pharmaceutical product. If you notice the medicines in your medicine cabinet, there are high chances of finding a ‘use by’ date on the packaging or the prescription. Pharmaceuticals are most benefited by stability test chambers, but it can also be used for many products whose performance must be maintained in many climates found around the world.
Who sets the rules for Stability testing?
A strict set of rules and regulations are applicable when it comes to stability testing. Guidelines are issued by the International Conference on Harmonization (ICH), the World Health Organization (WHO), the Food and Drug Administration (FDA), or any other significant agencies.
Stability Testing is not as easy as it sounds
Reading about it gives the impression that Stability testing is very easy and it only includes placing a drug in the chamber and set the parameters to determine how long a drug can maintain its potency. But that is not the case.
Here are a few of the many stability tests that can apply to a new product:
1. Quality, purity, potency, and identity are some of the things which could be expected to change upon storage and are chosen as stability tests.
2. Appearance, assay, degradation products, microbiological testing, dissolution, and moisture are standard tests performed on stability test samples.
3. Microbiological tests include sterility, preservative efficacy and microbial count as applicable e.g. for liquid injectable preparations.
4. Other tests like enantiomeric purity, particle size, and polymorphic form are also chosen as stability tests.
5. Packaging Integrity
6. Resistance to light.
Pharmaceutical products may undergo various changes in chemical stability as well as other characteristics such as physical appearance, consistency, etc. And the Stability test criteria varies accordingly.
Thermolab Group offers a wide range of Walk-in Stability Chambers to choose from based on your needs and requirements. With a promise of amazing quality and guaranteed after sale services, Thermolab is the reputed and ideal choice when it comes to Stability chambers in the pharmaceutical industries. We hope this article has been helpful and has helped you understand the basics of the stability chamber.
For more information about Stability Test Chambers, contact Thermolab Scientific Equipments.
