The major factor that decides a product’s success in the marketplace is the time that product will last before its safety 
or quality is compromised. Determination of the shelf life of a product can be a difficult task because every product has a different chemical composition and might be utilized under varying conditions.
However, the results of stability studies can assist in the research and development of your product, as well as help in quality assurance management for different product types. Stability study can be defined as a routine procedure performed on food items, consumer goods, drugs, and other products, and is employed at various stages of the product development. Stability studies help to ensure that the product retains its characteristic texture and flavour, as well as the chemical and structural features throughout the length of its shelf-life.
Shelf Life Estimation
Product shelf life study design should to be scientifically sound and should support the eventual results that would be utilized in the marketplace. Shelf life can be estimated by the following stability study models:
- Real Time Stability Studies
Real time stability studies help to establish or confirm long term product stability. This type helps to evaluate the performance of a product based on its activity and physical characteristics for the projected lifetime. This type also helps in determination of product expiration. Real-time stability testing is performed for longer duration of the test period to allow significant product degradation under recommended storage conditions.
- Accelerated Stability Studies
Accelerated stability study is a modified stability study method that helps to quickly estimate the life span or expiration date of a product when real time data is unavailable. This type of study is carried out by subjecting the product to elevated stress levels (usually controlled changes in humidity or temperature. The accelerated stability study allows the release of a product to the market based upon successful product testing.
- Open Stability Studies
Open stability study is also known as the “in use” stability study, which is designed to mimic normal use effects. This study type helps the manufacturers to guide the end users of the product. In-use or open stability studies help in evaluating multi-use reagents. Therefore, this type of study allows a specific recommendation for product use after the product is opened and put into general use.
Stability studies have now become the key procedural component in the development and manufacturing of products such as foods, consumer goods, and drugs. Stability studies are also performed so that the recommended shelf life and storage conditions can be mentioned on the label. With time, and increasing attention and experience, the regulatory requirements for product manufacturing have become more stringent. Stability studies make sure that the product is able to sustain its original characteristics in all possible conditions to which it might be subjected during its shelf life. Thus, stability studies should be carried out with proper understanding and knowledge of scientific principles as well as the current regulatory requirements.
For more insights on the various useful techniques and methods used to conduct the analysis of resulting data and stability study to estimate shelf life, attend this Webinar by expert speaker Steven Wachs. Steve has 25 years of wide-ranging industry experience in both technical and management positions. During the session, you will also be able to determine the steps required to set-up a stability study as well as understand the results which will estimate the shelf life of a product.
