Shelf life validation

What is the goal of a Shelf-Life-Validation?

Shelf-life refers to the expiration date or the expected lifespan of a product. During storage, the risk associated with using the product must not increase over time, and it must continue to function under conditions considered normal. In the context of PAConsult: the shelf-life of medical devices, with particular importance for the safe use of the product.

The goal of shelf-life validation is to determine the shelf life of a medical device and its packaging. This process verifies how long the product or packaging maintains its desired properties, quality, and safety before it no longer meets normative requirements. Various factors such as composition, storage conditions, and maintenance of product sterility are taken into account. Validation enables the determination of the shelf life of a medical device and its packaging to ensure it remains safe and of high quality for the user and patient. By conducting shelf-life validations, manufacturers can determine how the product and packaging react to various external factors such as temperature, humidity, or light and establish corresponding storage and packaging regulations.

What happens during a Shelf-life-validation?

In a shelf-life validation, the duration is determined within which the storage of a product does not lead to an increased risk. This is achieved by validating the packaging or product construction and storage conditions. Changes in material properties must be taken into account. For medical devices or sterile barrier systems, shelf life is a fixed parameter. If this shelf-life value is exceeded, it can no longer be guaranteed that sterility is maintained, even without material changes.

According to DIN EN ISO 11607-1, sterile barrier systems must maintain the sterility of the medical device being sterilized in the final packaging until the point of use. To ensure this, the integrity and seal strength must be verified over the predetermined shelf life.

Shelf-Life Validations by PAConsult: We create customized validation and revalidation plans for our clients' medical devices and support you in defining product and packaging families, as well as in determining 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 transport, and that they comply with specific legal and technical requirements. It is of particular importance for medical devices. The validation of the shelf life of medical devices 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