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
- 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
- <661.3> Plastic Components and Systems Used in Pharmaceutical Manufacturing
- <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact
- Workshop e-program
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.
Registration is payable by credit card only. Registration fees for this workshop have been set as follows:
|Participant Type||Fee Per Person|
|Streaming Participant (not attending in person)||$275|
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 email@example.com. 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 firstname.lastname@example.org.
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 email@example.com
Please contact firstname.lastname@example.org or +1 301-816-8130.
Local Area Information
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