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What is the goal of a Shelf-Life-Validation?
Shelf life refers to the shelf life or the expected service life of a product. During storage, the risk of the product during use should not increase over time and should continue to fulfill its function under the conditions considered as standard. In the context of PAConsult: the shelf life of medical products with particular significance for the safe use of the product.
The aim of a shelf life validation is to determine the shelf life of a medical product and its packaging. This involves checking how long the product or packaging retains its desired properties, quality and safety before it no longer meets the normative requirements. Various factors such as composition, storage conditions and maintaining the sterility of the product are taken into account. Validation makes it possible to determine the shelf life of a medical product and the packaging to ensure that it remains safe and of high quality for the user and patient. By performing shelf-life validations, manufacturers can determine how the product and packaging react to various external factors such as temperature, humidity or light and establish appropriate storage and packaging instructions.
What happens during a Shelf-life-validation?
Shelf life validation determines the period of time during which the storage of a product does not lead to an increase in risk. This is done by validating the packaging or product structure and the storage conditions. The change in material properties must be taken into account here. The shelf life is a fixed value for medical products and sterile barrier systems. If this shelf life value is exceeded, it can no longer be guaranteed that sterility is maintained, even without changing the material.
According to DIN EN ISO 11607-1, sterile barrier systems must maintain the sterility of the medical product to be sterilized in the final packaging until the time of use. To ensure this, the integrity and seal strength must be checked over the duration of the specified shelf life.
Shelf-life validations by PAConsult: We create individual validation and revalidation plans for our customers' medical products and support them in defining product and packaging families as well as the worst-case scenario to be tested.
In which areas are shelf-life-validations used?
Shelf life validations are required in many industries where the shelf life of packaged products must be ensured during storage or transportation, as well as that they meet certain legal and specific requirements. It is particularly important for medical products.
The validation of the shelf life of medical products is part of the validations according to DIN EN ISO 11607-1 and also serves to demonstrate compliance with the requirements of the essential safety and performance requirements of Regulation (EU) 2017/745.
Standards: DIN EN ISO 11607-1, ASTM F1980
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