A condition for the protection of the products is the ideal primary packaging protecting the product against microbiological and other contamination and practically preventing a change in the product quality through environmental conditions. Container closure integrity testing is the method for testing the functionality of the primary packaging.
Labor LS offers two methods: microbiological testing (microbial immersion testing) as well as dye ingress testing. Due to our extensive equipment, know-how and a variety of preparation options we are capable of conducting an individual test design for our customers.
The development of a specific test method is tailored to the specific product requirements, taking into account the closure system, product formulation and the mode of application. In addition to the applicable guidelines (USP <1207 >, International Standard ISO 8362-2 Annex C, ISO 3826-1 Annex C, ISO 15747 Annex 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 pharmacopoeias, we also rely on the experience from numerous studies.
Dr rer nat Carola Matthies
Press release dated 23 April 2018
Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
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