As referenced under USP <671> and outlined under USP <87> and <88>, we provide testing to determine the biological reactivity in vitro and in vivo of your plastic container components. Under USP <87>, there are three distinct test methods based upon the material of composition for the sample under test. The agar diffusion method is specific to rubber stoppers and the elution method is specific to plastic materials. The USP <88> test requirements present test methods that enable a sample to be classified as Class VI. Class VI plastics meet the most stringent requirements for classification.

Our experts conduct the following 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 VI Plastic Testing

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