Modernization of USP Packaging Standards for Glass and Elastomeric Components

June 19, 2017 - June 20, 2017

Overview

Overview: 

Glass and elastomeric materials used in packaging systems must be shown to be suitable for their intended applications. To address these issues, USP is revising two existing USP-NF chapters <381> Elastomeric Closure for Injections and <660> Containers−Glass and proposing three new chapters <1381> Evaluation of Elastomeric Components Used in  Pharmaceutical Packaging/Delivery Systems, <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems and <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems.

Objectives

This two-day workshop will address the following: 

  • Key issues surrounding USP’s requirements for materials of construction for pharmaceutical packaging systems (glass, elastomers, and beyond)
  • USP’s proposed revision to General Chapter <381>
  • Regulatory expectations regarding the suitability of glass components and systems used for pharmaceutical drug products 
  • USP’s proposed revision to General Chapter <660>
  • Regulatory expectations regarding the suitability of elastomeric components and systems used for pharmaceutical drug products
  • USP’s proposed  General Chapters <1381>, <382> and <1382>

Why Attend?

  • Learn about USP proposals surrounding biocompatibility testing, chemical characterization, and risk-based testing strategies
  • Help shape the future revision of <381> Elastomeric Closure for Injections and <660> Containers−Glass
  • Hear the rationale behind the proposed new chapters, <1381>, <382> and <1382>
  • Help shape the final version of <382>, <1382> and <1381>

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

  • Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems <1663>
  •  Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664>

Registration Information

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8136