Navigating the Transition Away from USP <88> Class VI in Biopharmaceutical Manufacturing
Why the Industry is Evolving - and What It Means for You
For decades, USP <88> Class VI testing has been a benchmark for biocompatibility in elastomers used in biopharmaceutical manufacturing. But, as Cory Perelman, Lead Instrumentation & Controls Engineer at Arcadis outlined in his presentation at the 2025 Mid-Atlantic Science & Technology Showcase, industry standards are evolving—and with growing concerns over animal testing and regulatory clarity, the shift away from USP <88> is gaining momentum.
What's Changing?
The biopharmaceutical industry, backed by regulators and industry consortiums like BioPhorum, is moving toward risk-based, in vitro testing approaches. This change is reflected in the phasing out of USP <88>:
- USP <87>, which includes cytotoxicity and in vitro testing, will continue to be relevant and expanded.
- USP <88> is no longer recommended for evaluating elastomers used in bioprocessing.
- Newer, more relevant standards are emerging—most notably, USP <665>, which will be enforceable by the FDA and effective May 1, 2026.
- USP <88> will soon only reference systemic injection testing, narrowing its scope. This update goes into effect December 1, 2026.
Why the Change?
1. Ethical testing: The industry is prioritizing reduction of animal testing wherever possible.
2. Greater relevance: Testing that aligns with actual process conditions and intended use cases offers more actionable insights.
3. Regulatory clarity: USP <665> brings enforceable, standardized expectations that better reflect real-world applications in biomanufacturing.
What Brooks Instrument is Doing
At Brooks Instrument, we're gathering input and suggested next steps from key customers and sales partners to support this industry shift:
- Our SLA Series mass flow controllers with the Biotech options package offers USP Class VI/ADI-free elastomers that meet current and emerging standards like FDA 21 CFR 177.2600 and ISO 10993.
- Our team is monitoring standards from ASME-BPE and customer requirements to adapt quickly with multiple configurations and certifications during this transition.
- We're preparing a customer-friendly guide for evaluating o-rings and elastomer selection for bioprocessing use, expected in early 2026.
What You Should Do
- Stay informed: Track how OEMs, integrators, and regulators are revising requirements.
- Plan ahead: Begin phasing out references to USP <88> and Class VI in your documentation.
- Reach out: Contact us if you have new elastomer qualification needs.
