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Container Closure Integrity

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.

Your contact person:

Dr rer nat Carola Matthies 
Graduate Biologist

+49(0)9708/9100-160
carola.matthies@labor-ls.de

News

Zauberland der Mikrokosmen

Am Samstag, den 23.02.19 öffnete die Labor LS SE im Rahmen der Kinder- und...


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Events

Prüfung von pharmazeutischen Rohstoffen

20. März 2019, Fulda Hotel Esperanto (Labor LS)


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Transfer analytischer Methoden und Verfahren (A19)

08. bis 10. Mai 2019, Heidelberg (Concept Heidelberg)


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Contact

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Großenbrach

Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
E-Mail: service@labor-ls.de

Infobox

In our Infobox, we make additional information on our company, our service portfolio and our QM certification available to you in a download. 

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