Extractables & Leachables Testing of Single-Use Systems for Production - Karen Pieters

Описание к видео Extractables & Leachables Testing of Single-Use Systems for Production - Karen Pieters

Leachables in pharmaceutical products could originate from manufacturing
items (filters, bioreactors, etc.) used in the pro duction process. With the increasing use of disposables in the pharma industry, the concern
in E&L has also developed considerably. Biopharma industry groups (BPSA,
BPOG) have published recommendations when and how to perform E&L
studies for these materials. More over, the USP has released chapter 665
and 1665, which ad dress E&L for production materials in the (bio)
pharmaceutical industry. The different steps in the assessment of the E&L impact of a production line will be outlined In this presentation. In addition, the recommendations of BPOG and USP for these materials will be discussed.

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