As referenced in specific container and package USP General Chapters, it is required for certain materials that USP <87> Biological Reactivity Testing be performed. This is specific to Elastomeric Material as referenced in USP <381> and for certain plastic types as referenced in the various versions of USP <661>. 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.
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.
Agar Diffusion – this method is used for elastomeric (rubber) closures
Elution Test – this method is primarily used for polymeric (plastic) materials
Direct Contact Test -typically not used or required for container / package system components, it is designed for all other materials that are not elastomer or polymeric.
In addition to, and dependent on the results of the USP <87> testing, some samples may require additional testing as referenced under USP <88> 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.