If medicinal products are marketed in sterile form, integrity testing of the packaging materials is an essential quality feature for these products. Using Container Closure Integrity (CCI), it is checked whether the packaging protects the product from microbiological and other contamination and practically excludes changes in product quality due to environmental influences. In particular, special transport conditions by land and by air are also taken into account. To this purpose, Labor LS offers you three different test procedures from the USP <1207>:
- Microbial Ingress Test
- Dye Ingress Test
- Detection of oxygen by means of laser-based headspace analysis technology
Due to our extensive equipment, our know-how and a multitude of preparation possibilities, we can conduct an individual test design for you. In addition to the guidelines (USP <1207>, International Standard ISO 8362-2 Appendix C, ISO 3826-1 Appendix C, ISO 15747 Appendix C, PDA Technical Report No. 27, FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products) and pharmacopoeia regulations, the empirical values from numerous studies are also used for the development of a specific test method tailored to the requirements of a product, taking into account the closure system, the product formulation and the type of application.
We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts: