Session 3: Breaking the Mold: The Biotech Industry says Goodbye to USP Class VI Plastics
3:00 PM – 3:45 PM | East Red Level, Suite 10
Breaking the Mold: The Biotech Industry says Goodbye to USP Class VI Plastics
The USP requirements for Biocompatibility, USP 87 and USP 88, have been updated for an effective date of May 1, 2026, with broad sweeping impacts for the Biotech industry. USP 87 now includes many additional tests for in-vitro testing. USP 88 has been gutted, with references to Class VI plastics entirely removed and industry guidance revised to point away from in-vivo (animal testing). These tests were not specifically required by law for the biotech industry, but for the containers, medical devices and implants industry. They were picked up as GMP practices by ASME BPE and became ubiquitous in the industry. Now, USP 665 has been released with an effective date of May 1, 2026 as well, for plastic components and systems used for the manufacture of Biopharmaceuticals, and is specifically for characterization and qualification of plastic components and systems in OUR industry. However, it leaves some elastomers out of scope – so what do we do? This presentation takes you on tour through the history of USP 88’s Class VI’s use in Biotech, including adoption into single-use, it’s ultimate removal from the USP 88 guidelines, and where the industry is now heading instead, as well as what changes need to be implemented to comply by May, 2026.
Speakers:
Cory Perelman, Lead Instrumentation, Controls and Automation Engineer – Solutions, Arcadis
Jim Vogel, Founder and Director, BioProcess Institute
Biographies:
Cory Perelman, Lead Instrumentation, Controls and Automation Engineer – Solutions, Arcadis
Cory Perelman is a Lead Instrumentation, Controls and Automation Engineer at Arcadis. He is a vice chair for instrumentation and a leadership member of ASME BPE. He specializes in all aspects of control system design, innovating specifically in the fields of single use instrumentation, smart instrumentation and sustainability.
Jim Vogel, Founder and Director, BioProcess Institute
is a recognized subject matter expert in bioprocessing and biotechnology, with more than 40 years of experience in the biopharmaceutical, food and cosmetic industries. Mr. Vogel’s passion for the industry took root during his college years and the expertise and experience he has acquired throughout his career, has shaped his balanced approach to testing, training, and consulting.
In 2007, Mr. Vogel founded The BioProcess Institute to satisfy the BioPharmaceutical industry’s need for expert testing, training, and consulting all in one place. He also combined his experience with suppliers and end users to benefit them both. He leads a strong team of engineers and specialists who help The Bioprocess Institute provide valuable, customized solutions for a complex industry.
He has worked as a Director, Project Manager, and Engineer (Plant Support, Process Development, Project and Automation) with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton and Avon. As lead designer for Amgen’s Rhode Island Facility, a $700 million, large scale biopharmaceutical plant. In addition, he directed numerous facility renovations including upgrades and optimizations to the buildings, process equipment, utilities, and laboratories.
Mr. Vogel’s, consulting expertise lies in all areas and all levels of engineering, management, and cGMP. Including single-use and multi-use applications. He has troubleshot plant operations for both process and utilities helping with organizational structures and staff development. One key area of his expertise is performing risk assessments for both operational and engineering systems.
Using his experience and expertise, Mr. Vogel has also trained thousand of industry professionals on topics including single-use technologies, biopharmaceutical manufacturing and bioprocessing best practices.
