Quick Definition
What is USP Class VI?: USP Class VI is a certification standard from the United States Pharmacopeia defining minimum biological reactivity requirements for plastics in pharmaceutical and medical device applications. USP Class VI materials have been tested and confirmed not to elicit toxic or inflammatory responses — making it the baseline requirement for product-contact plastics in biopharmaceutical manufacturing.
USP Class VI vs ISO 10993
USP Class VI tests extract the material under defined conditions and assess biological reactivity of the extract in animal models. ISO 10993 is a broader biocompatibility standard including cytotoxicity, sensitisation, genotoxicity, and implantation. USP Class VI is used as a preliminary screen and routine lot qualification; ISO 10993 is performed once for a new material and does not need to be repeated per lot.
USP Class VI and extractables/leachables
USP Class VI confirms that gross extract does not cause acute biological reactions — it does not characterise specific chemical substances leaching from the material. For IND/BLA regulatory submissions, E&L data from the specific bag film at relevant extraction conditions is separately required. SeamlessBio provides E&L data on request.
Key Facts
- USP <88> Biological Reactivity Tests, In Vivo — six plastic classes (I–VI); Class VI is the most stringent in vivo test
- Three in vivo tests: systemic injection test (mice), intracutaneous test (rabbits), implantation test (rabbits for 5 days)
- A material passes USP Class VI if no significant biological reaction is observed in any of the three tests
- All SeamlessBio single-use bioprocessing bags are USP Class VI certified — film contact layer tested per lot
- USP Class VI does NOT cover trace-level extractables/leachables — separate E&L testing required for regulatory submissions
- Complements ISO 10993 biocompatibility testing for medical devices
Further Reading
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