Steady State Stability Testing of Pharmaceutical Products

Posted: Jan 28, 2021

The pharmaceutical industry requires stability storage and testing for their products.  This ensures that their product will maintain an acceptable level of quality during the product life cycle. This testing documents how stable a product is and provides evidence of variation of efficiency and integrity of the product over time. It considers the effect of different physical, chemical, and microbiological factors.

This type of pharmaceutical testing is done by placing samples of a drug in a steady-state stability test chamber that simulates different temperatures and humidity conditions. Different samples are removed from those conditions at different times to observe the effects. A variety of tests that include an identification test, physical tests, microbiological limits, preventiveness effectiveness test, and more are performed on the samples. Observations are noted to study the variations under the different factors.

Types of Stability Testing for Pharmaceutical Products

The duration of time during which a drug remains useful is determined by stability testing. There are two types of tests used for this: real-time stability tests and accelerated stability tests. Both of these tests are performed in a steady state stability chamber to establish the estimated lifetime and expiration of a product. Read on as we explain the benefits of both types for pharmaceutical testing.

Real-time Stability Test

If the long-time product stability is to be evaluated, a real-time stability test is performed. This study provides the evaluation of the performance of the product based on different physical or chemical characteristics and evaluates the activity of the product for the projected lifetime. This study helps in determining the expiration date of the product. Typically, the real-time stability test is done for the time periods ranging from 6 months to 5 years depending upon the requirement of the client.

Accelerated Stability Test

When the real-time data is not available and the life duration of a product needs to be estimated, the accelerated stability test is used. These are a modification of a real-time stability test. The products are subjected to an enhanced level of stress or controlled changes in temperature and humidity to carry out an accelerated stability test. This test is used to cycle through multiple stages of stresses, making the pharmaceuticals react as they would during a shipment and long storage. The testing chamber simulates the rapid acceleration of time and conditions to put the product through its paces.

Lunaire Environmental Steady-State Stability Testing Chambers are utilized for many applications in pharmaceutical testing that include stability and shelf-life testing, package testing, aging testing, reliability testing and many more applications. These chambers provide an environment where the effects of humidity and temperature can be tested on products. Lunaire test chambers are available in a variety of sizes and offer testing flexibility for a wide range of applications due to the number of humidity and temperature combinations offered.

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