Material Biocompatibility and Standard for Plastic Manufacturing Systems/Components

Plastics and elastomers used in packaging systems, medical devices, or manufacturing systems must be shown to be suitable for their intended applications. Biological reactivity testing is one such process used for determining suitability and safety.

Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, these plastic assemblies illicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety.

To address these issues, USP is revising two USP-NF chapters on biological reactivity and is proposing a new general chapter to establish a standardized extractable procedure for plastic components and systems used in medicinal product manufacturing.



This two-day workshop will address the following:

  • Key issues surrounding USP’s biocompatibility requirements for materials of construction (plastics, elastomers, and beyond)
  • USP’s proposed revision to General Chapter <87> Biological Reactivity, In Vitro and <88> Biological Reactivity, In Vivo
  • Regulatory expectations for biocompatibility testing
  • USP’s proposed General Chapter <661.3> A Standardized Procedure for Extractables from Manufacturing Components and Systems
  • Regulatory expectations regarding the suitability of plastic components and systems used in manufacturing

Why Attend?

  • Learn about USP proposals surrounding biocompatibility testing, chemical characterization, and risk-based testing strategies
  • Help shape the future revision of <87> Biological Reactivity, In Vitro and <88> Biological Reactivity, In Vivo.
  • Hear the rationale behind the proposed new chapter, <661.3> Plastic Components and Systems Used to Manufacture Pharmaceuticals Drug Products.
  • Help shape the final version of <661.3> Plastic Components and Systems Used to Manufacture Pharmaceuticals Drug Products.

Who Should Participate?

  • Research and development scientists, engineers, toxicologists
  • Contract research organizations
  • Contract manufacturing organization
  • Regulatory affairs professionals
  • Quality assurance/quality control professionals

Related Chapters

Advance Registration Deadline

Advance registration will be available through June 15, 2016. After that date, registration will be available on-site at the USP Meetings Center.

Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the ‘REGISTER’ button.

Pricing Information

Registration is payable by credit card only. Registration fees for this workshop have been set as follows:

Participant Type Fee Per Person
Academic Participant $375
Government Participant $250
Industry Participant $475
Nonprofit Participant $375
Streaming Participant (not attending in person) $275
Student Participant $150

Registering Others

When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).

Cancellation and Substitution Policy

Cancellation must be received on or before May 30, 2016 (21 days prior to the event) via email to Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations. However, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees. However, once registered USP will provide a registration confirmation that may be utilized to obtain a visa. You may request this confirmation by contacting

Registration Questions

Please contact or +1 301-816-8130.

Local Area Information

Visit our Travel & Transportation page for information on lodging, airports, and local transport in and around USP's Rockville, Maryland, campus.

Face-to-Face Meeting, USP–U.S. 12601 Twinbrook Parkway Rockville, MD 20852-1790, USA