Revised USP <87>: How To Prepare For Risk-based Biological Reactivity Testing

By Jillian Miller, Microbiology Manager, Pace® Life Sciences

For years, a USP Class VI designation could function as the finish line for material qualification. The revised USP <87> asks for something different: a documented, risk-based justification tied to how a material is actually used. Jillian Miller, Microbiology Manager at Pace Life Sciences, works through what that means in practice. She considers where familiar elution and direct contact methods still fit, what a quantitative method like neutral red uptake adds, and how testing needs may differ between an injectable stopper, a single-use bag, and an implantable component. She also addresses what to do with existing Class VI data and names the assumption she sees as the most common pitfall.

Read Miller's analysis to see how a gap assessment and earlier planning could shape your own program.