USP <87> Biological Reactivity Testing is a required test for plastic and elastomeric materials for parenteral dosage forms and medical devices, as referenced in specific container and package USP General Chapters:
> Elastomeric Material referenced in USP <381> https://csanalytical.com/physicochemical-testing/usp-elastomers/
> Plastics referenced in the various versions of USP <661> https://csanalytical.com/usp-plastic-packaging-systems-and-their-materials-of-construction/ https://csanalytical.com/physicochemical-testing/usp-plastic-materials/ https://csanalytical.com/physicochemical-testing/usp-661-2-plastic-packaging-systems/
The USP <87> test is designed to determine the biological reactivity of mammalian cell cultures following direct or indirect contact with the test article or from specific extracts prepared from the material being tested. The sample component being tested along with positive and negative controls is extracted in culture media for 24 hours at 37°C in a humidified incubator containing 5% carbon dioxide. The cells are incubated for 48 hours and observed microscopically for cytotoxic effects. Cultures are observed under microscopy and graded for reactivity using a 0 to 4 scale. Test article meets the requirement of the test when results are less than a grade of 2. This test can preclude animal testing for elastomers and plastics, offering a faster humane screening.
There are three distinct test methods that may be followed under the USP <87> procedure and selection of the specific method is dependent on the type of material being testing, as well as its intended use.
Agar Diffusion Test
Can be used for materials too heavy for the direct contact test where close contact is indicated. In this method, the test article is placed directly on or near an agar layer covering cultured cells. The agar acts as a medium through which extractables can diffuse, and zones of cellular reactivity are observed and measured.
Elution Test
Used for elastomeric (rubber) and polymeric (plastic) materials and other materials where product contact and extraction is indicated. Extracts are prepared from the test article using appropriate extraction vehicles (typically cell culture media), and these extracts are then applied to cell cultures to assess cytotoxic potential.
Direct Contact Test
Designed for materials that are lightweight and where close tissue contact is indicated; typically not required for container/package system components. The test article is placed directly onto the cell culture layer, allowing for direct assessment of material biocompatibility.
In addition to, and dependent on the results of the USP <87> testing, some samples may require additional testing as referenced under USP <88> Biological Reactivity – In Vivo testing. If this requirement is applicable to your specific sample type, a CS Analytical representative will review the requirements and provide direction specific to your package system and enclosed drug product or medical device.