24 Jan 2023

On the Origin of Extractable Species

In this webinar, originally broadcast as part of the Pharmapack Europe show, Piet Christiaens, Scientific Director, Nelson Labs talks about the Universe of Extractables and how there are many different types of materials being used in the construct of a Container system. The impurities profile of a material is typically composed of compounds that were intentionally added to a material to protect the material during production or its life cycle or to increase performance or functionality. In this case, he is talking about polymer additives. However, there is even a longer list of compounds that are present in a material that were not intentionally added. These compounds have been introduced during the production process of the material, or they are the result of ageing of the material. The presentation will give an overview – for the most common materials used in the construct of container/closure systems or medical devices – of the main classes of compounds that are often detected in extractable studies.

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Nelson Laboratories LLC

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  • 2018
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Other Content from Nelson Laboratories LLC (3)

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    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.