Stability is “The limit to which a product or medical device retains, within the specified extent of time, or throughout its period of storage and use, i.e. termed as, its life span or self-life, the same properties and characteristics that it possessed at the time of manufacturing of product or device.”
The purpose of the stability study is to give information on how the quality of products does not vary with time under the influence of a variety of environmental factors such as temperature and humidity.
There are internationally accepted standards for assessing medical device stability in general and also certain product specific standards based on the product type. Applicable standards have to be identified before initiating the studies.
The stability of product can be demonstrated in 2 ways:
Accelerated stability:In accelerated stability tests, a product is kept at elevated stress conditions (such as temperature, humidity, and pH) for a shorter period of time.
In real-time stability testing, a product is kept at recommended storage conditions and tested at periodic intervals until it fails the specification.
The product can be released in the market based on the data of accelerated stability study, however, real-time stability studies shall be carried out simultaneously.
After a marketing authorization has been granted, the stability of the products should be appropriately monitored according to a continuous Programme that will permit the detection of any stability issue (e.g. changes in levels of degradation products)
Maven helps you to design a Stability study Plan and reduce errors.
Written test protocol specifying the accelerated aging conditions (test temperature, humidity, cycle, ambient temperature), rationale for selection of samples, time frame, sample sizes, package description, time for sampling interval, and specific tests at each time interval must be developed before testing.
Document the temperature of the stability chamber used
Document the test standard references and methods used for packaging evaluation.
Accelerated aging studies provide alternate means in a case where the product becomes obsolete in a short time due to market conditions and there is a need to get a new product to the market in the shortest possible time.
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