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In-Use Tests

In-use tests simulate the application of a product in order to determine its microbiological or chemical-physical stability in real-life conditions and, if necessary, its shelf life after opening. The focus is often on medicines and cosmetics in multi-dose containers, where product removal is a microbiological risk and where the potential contamination with pathogenic microorganisms during use poses a possible health risk.

Labor LS creates test plans for this purpose and develops a test design adapted to the product and its use. For certain products, the test design may include, in the simulation, microbiological flora occurring specifically at the application site. Quality evaluation tests in the context of in-use tests may be sterility tests, microbial purity tests, tests for adequate preservation or chemical-physical tests.

General requirements for in-use stability tests of human and veterinary pharmaceuticals are specified in the corresponding CPMP and CVMP guidelines of the EMA (European Medicines Agency). In accordance with the cosmetics regulation for certain cosmetic products, a “period after opening” (PAO) needs to be specified.

Guidelines:

  • CPMP/QWP/2934/99 Note for Guidance on In-Use Stability Testing of Human Medicinal Products
  • EMA/CVMP/424/01 Note for Guidance on In-Use Stability Testing of Veterinary Medicinal Products (Excluding Immunological Veterinary Medicinal Products)
  • CPMP/QWP/159/96 corr Note for Guidance on Maximum Shelf-Life for Sterile Products for Human Use after First Opening or Following Reconstitution


Your contact person:

Dr rer nat Carola Matthies 
Graduate Biologist

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

News

LS opts for a future-oriented corporate structure

Press release dated 23 April 2018


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Events

aseptiKon 2018

25./26. September 2018, Wiesbaden


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Emulsions & Gels

10.-11. Oktober 2018, Wien (ECA)


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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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