USP <87> - Biological Reactivity Tests, In Vitro

What it says

General Chapter <87> describes in vitro biological reactivity testing, using cell culture-based methods to assess the biocompatibility of plastics, elastomers and other materials intended for use in pharmaceutical packaging and manufacturing components that contact drug products.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This chapter provides an initial, generally lower-cost screening approach to material biocompatibility, often used as a first assessment before more extensive in vivo testing under Chapter <88> is considered necessary based on the material's intended use and contact duration.
• Cell culture-based testing methodology means results reflect direct cellular response to material extracts, providing a biological reactivity indicator distinct from and complementary to the chemical extractables and leachables assessment described under ICH Q3E and USP <1663>/<1664>.
• Material qualification for pharmaceutical packaging and manufacturing components often requires this testing alongside, not instead of, the broader physicochemical and extractables characterisation covered elsewhere in this library.

What inspectors look for

• Whether in vitro biological reactivity testing was performed and documented for materials genuinely contacting the drug product, appropriate to that material's specific use.
• Whether test results are appropriately interpreted against established acceptance criteria for the material's intended application.
• Whether a material change triggers reassessment of biological reactivity, not assumed equivalent based on general material category alone.

Related regulations