GLASS meets PHARMA

USP - Ph. Eur. - ECA Joint Conference

6-7 June 2018, Berlin, Germany

USP General Chapter  - major revisions coming in 2018!

Highlights:

  • Regulatory Requirements: EU, USA
  • Update of USP General Chapters <660>, <1660>, including proposed revisions
  • Update of Ph. Eur. Chapter 3.2.1
  • Glass Delamination
  • Glass Particles (Particle Contamination in Parenterals)
  • Specific Aspects for moulded and tubular glass
  • Extractables & Leachables testing for Glass?
  • Glass formulations with enhanced chemical stability
  • New technologies in filling lines
     

Background 

Glass materials used in packaging systems must be shown to be suitable for their intended applications. To address these issues, USP is currently revising its general chapters <660> Glass Containers Used in Pharmaceutical Packaging/Delivery Systems and <1660> Glass Containers Used in Pharmaceutical Packaging/ Delivery Systems: Manufacture and Evaluation of the Inner Surface Durability.

Glass is not fully inert. Therefore, in addition to the glass surface tests, Extractables & Leachables have to be taken into account. Furthermore, in the last number of years, delamination (resulting in “Glass flakes”) and visible foreign particulate matter (i.e. glass particles), became the number one reason for recalls in the pharmaceutical industry. Therefore the attention and demands of the authorities has increased, with a special focus on root cause investigation of the particle contamination. Compendial chapters have been changed and specified accordingly. FDA inspectors like to see the staged investigation cycle approach.

Packaging materials also have to be described in the registration process of a drug product according to the particular requirements. The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products and biologics. To cover all relevant aspects a thorough target product profile needs to be set up.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed, in conformity with the specifications and in compliance with the regulatory requirements. In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, the “Defect Evaluation Lists” have proved efficient. The responsibility for the tests lies now more and more with the suppliers of packaging materials, while the pharmaceutical industry tries to reduce testing at the same time.

This two-day conference will address the following:

  • Key issues surrounding USP’s and Ph.Eur.´s requirements for glass materials of construction for pharmaceutical packaging systems.
  • „Regulatory expectations regarding the suitability of glass components and systems used for pharmaceutical drug products.
  • USP’s proposed revision to General Chapter <660>.
  • Future developments and challenges.

Objectives

  • Learn about USP proposals surrounding testing, chemical characterization, and risk-based testing strategies
  • Help shape the future revision of <660> Containers−Glass
  • Hear the rationale behind the proposed chapters <660> and <1660>
  • Get deep insights in physical and chemical aspects of tubular and moulded glass
  • Use the opportunity to discuss with speakers from industry, authorities and colleagues from other companies and suppliers

 

Conference presentations, case studies and open discussions will help participants learn more about the glass packaging materials and analytical procedures and provide a forum for discussing USP’s revised general chapters related to this topic. Participants will thus have the opportunity to give feedback and ask questions directly to USP’s Expert Panel Members.

The meeting will also address topics such as:

  • Delamination
  • „„Control of glass particles and new approaches in packaging pressure monitoring
  • Extractables & Leachables
  • Regulatory expectations
  • Glass formulations with enhanced chemical stability