Evaluating USP 665 For Extractables Testing And Reducing Animal Testing For Biological Reactivity
Evaluating extractables & leachables and performing a risk-based approach is a key step for single-use manufacturing. With USP <665> approval in 2021, transitioning to this new standard is ongoing for polymeric material used in single-use manufacturing.
Animal welfare and reducing animal testing is also a key initiative. Biological reactivity testing has traditionally used both in vitro and in vivo methods. With the updates to the USP chapters, positioning cell-based assays of USP <87> and ISO 10993-5 is the primary method for determining Biological reactivity.
In this webinar, you will learn about the new and changing compendial methods and what it means for pharmaceutical manufacturing.
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