Webinar
24 Jan 2023
On the Origin of Extractable Species
Content provided by our supplier
Nelson Laboratories LLC
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US
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2018On CPHI since
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4Certificates
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500 - 999Employees
Company types
Primary activities
Other Content from Nelson Laboratories LLC (3)
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Brochure Extractables & Leachables
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Webinar A Risk-Based Approach Towards the Assessment of Process-Equipment Related Leachables - Case Study
Manufacturing processes are composed of a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final drug product, thereby potentially compromising its biocompatibility, safety or quality. At the same time, not all manufacturing components have the same likelihood to contribute to PERLs. A risk-based approach in which process conditions, type of process material and composition of the process solution are evaluated, allows the definition of relevant test requirements with respect to extractables and leachables. In this presentation, you'll have the opportunity to explore the main principles of a risk-based evaluation through a case study. -
Webinar Extractables & Leachables Qualification of the Primary packaging for Biological Products
In 2022, the final recommendations of the Product Quality Research Institute were published for Parenteral Drug Products. Apart from the wealth of information and considerations on design of extractable & leachable studies for parenteral drug products in general, it also contains valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. We will give an overview on the recommendations and how it affects the design of an extractable & leachable study for the primary packaging of biologics.
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