Accredited
Test Laboratory
What is the goal of a Shelf-Life-Validation?
The aim of a shelf-life validation is to determine the shelf life of a product. This involves checking how long the product retains its desired properties, quality and safety before it before it no longer meets the normative requirements. Various factors such as composition, storage conditions and maintaining the sterility of the product are considered. Validation makes it possible to determine the shelf life of a product and its packaging to ensure that it remains safe and of high quality for users and patients. By carrying out shelf-life validations, manufacturers can determine how the product reacts to various external factors such as temperature, humidity or light and establish appropriate storage and packaging instructions.
What happens during a Shelf-life-validation?
According to DIN EN ISO 11607-1, sterile barrier systems must maintain the sterility of the 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 and provide support in defining product and packaging families as well as worst-case scenarios to be tested.
In which areas are shelf-life-validations used?
Shelf-life validations are required in many sectors where the shelf-life of packaged products must be determined and it must be ensured that they maintain their quality and safety during storage or transportation and that they meet certain legal and specific requirements.
The validation of shelf-life is part of the validations in accordance with 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
Our Certifications
Accredited test laboratory PAConsult
Experience & Expertise
96
Test Methods
8
Industries
49
Employees
5
Locations