What Is Stability Testing?

The pharmaceutical industry must show purity, efficacy, potency, safety and integrity of a product through expiry.  Stability challenges aide in this evaluation by placing the product on station in an environmental chamber at known conditions and periodically testing the product.  Microbac is focused on supporting the industry with purity/potency and, to some extent, safety.

What Is An Environmental Chamber?

Environmental chambers are designed to operate in tightly controlled parameters in accordance with the parameters outlined in the International Conference on Harmonization (ICH). 

The product is placed into an environmental chamber at conditions that represent how the product will be stored during commercial use.  This can be as cold as -80°C (-112°F) to room temperature in the US.  In tropical areas of the world, product is stored at elevated temperatures to mimic the local climate.

The ICH recommends pulling a representative sample from the environmental chamber every three months the first year, every six month the second year and annually after that.  The sample is then subjected to a panel of tests.  Results of testing from each time point and condition are evaluated looking for trends.  This information is utilized when setting an expiration date for a product.