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Recommendations For Extractables And Leachables Testing
March 25, 2010
•Article: Recommendations For Extractables And Leachables Testing
By BioProcess International
Extractables and leachables from disposable manufacturing systems must be addressed as part of process validation. Extractables are compounds that can migrate from a material into a solvent under exaggerated conditions of time and temperature. Leachables are compounds that actually do migrate into a drug product formulation under normal processing conditions. All materials have extractables and potentially have leachables. When properly evaluated, both are easily addressed and rarely lead to disqualification of a disposable component.
No specific standards or guidances reference extractables and leachables from single-use, disposable bioprocessing materials. But there are regulatory guidances and industry–regulatory collaborations that address them for final containers and closures and for orally inhaled nasal drug products (OINDP). This conclusion of a two-part article takes the existing body of knowledge and guidances and applies them (where appropriate) to (where appropriate) to disposable bioprocessing materials.
Reprinted with permission from BioProcess International
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