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For more information visit the symposium website: https://slas.org/events/slas-2020-european-sample-management-symposium
Monday, March 16 • 10:55am - 11:15am
Supply Chain Management - Risks that Arise with Leachables from Single-Use Materials

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Single-use equipment just as any other plastic material can release leachables, thus possibly affecting the efficacy and safety of the pharmaceutical drug product or may lead to invalid results in the application of analytical methods. The most serious adverse effects are caused by leachable components generated in the plastic or coated film manufacturing process, particularly during plastic extrusion and gamma sterilization. Polymers and additives (antioxidants, plasticizers, or slip agents) can degrade as a consequence of the intense energetic treatment (high temperatures or irradiation). Under process conditions, this can lead to migration of leachables from the plastic surfaces into the process fluid. For example, degradation products include the recently identified substance bis(2,4-di-tert-butylphenyl)phosphate, which is a derivative of the processing stabilizer tris(2,4-di-tert-butylphenyl)phosphite (also known under the trade name IRGAFOS 168) Even very low concentrations < 1 ppm can inhibit cell growth. For single-use systems or consumables made from plastic, this usually leads to evaluations that demonstrate compatibility with the process fluids that stays in contact with the material under consideration. Therefore, an important part of qualification of single-use equipment consists of chemical safety assessment. Chemical safety means absence of leachables from the plastic material in the final product in concentrations of toxicological concern for the accordant clinical application.

Speakers
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Andreas Nixdorf, Ph.D.

Business Development Manager, SGS Institut Fresenius GmbH
Andreas studied organic chemistry at the University of Bielefeld in Germany with the main focus on mass spectrometry. Since the date of his PhD/doctorate in 1997, he worked in different scientific and managerial positions ranges from head of laboratory to GMP QA site manager in Life... Read More →

Chairs
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Oliver Peter, Ph.D.

Group Leader Biology Technologies and Lead Discovery, IDORSIA Pharmaceuticals Ltd


Monday March 16, 2020 10:55am - 11:15am
Room Saphir