As referenced under USP General Chapter <661> and outlined under USP General Chapters <87> and <88>, there are a series of biological reactivity test requirements specific to plastic container components. Falling under In Vivo and In Vitro classifications, these series of qualification requirements center on culture and animal-based testing procedures. Under USP <87>, there are three distinct test methods that are assigned based upon the material of composition for the sample under test. As noted in the test list, the Agar Diffusion method is specific to rubber stoppers and the Elution Method is specific to plastic materials. The USP <88> test requirements present of series of test methods that enable a sample to be classified out to level six – commonly required for use in the pharmaceutical product industry.
Specific Biological Reactivity Tests:
USP <87> Biological Reactivity – Direct Contact
USP <87> Biological Reactivity – Agar Diffusion (Rubber Stoppers)
USP <87> Biological Reactivity – Elution Method (Plastic Materials)
USP <88> Class Six Plastic Testing
Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.