Programme GLASS meets PHARMA

USP - Ph. Eur. - ECA Joint Conference

Please note that the Programme is continuously updated - check back at a later date for more Information.

Day one - 6 June 2018


 Introduction

Introduction to the ECA Foundation, the Ph. Eur. and the USP

  • ECA introduction (Dr Andrea Kühn)
  • USP introduction (Dr Michael Eakins)
  • EDQM introduction (Dr Ellen Pel)
     
 Overview

Overview of Key Issues for the Revision of USP Chapters <660> and <1660>

Dr Bettine Boltres

  • Update from the <660> Expert Panel: Review of the revision process for USP General Chapters <660> and <1660>
     
 Overview

Specific Aspects for Glass Containers made of Tubular Glass

Alfred Breunig

  • Overview of production processes for tubular glass containers
  • Overview of ISO Modifications in relation to tubular glass containers
  • Specific Defect Evaluation Lists
  • Change Control
     
 Speech

Biologics in Molded Glass

Vincent Langlade

  • Overview of production processes for molded glass
  • Overview of DIN ISO Modifications in relation to molded glass
  • Specific Defect Evaluation Lists
  • Modern Applications and Case Studies
     
 Speech

Glass Delamination

Horst Koller

  • What is delamination
  • What is the route cause
  • Contribution to delamination
  • How to avoid
  • How to control
     
 Speech

Elemental Impurities in Glass?

Dr Claudia Heinl

  • Glass types: Differences in composition
  • Chemical and physical properties
  • Potential Extractables & Leachables from glass
  • How to avoid
  • Elemental Impurities acc. to ICH-Q3D
     
 Speech

Extractables from Glass

Dr Jörg Zürcher

  • Risk evaluation of glass extractables
  • Concepts to avoid extractables from glass
     
 Speech

Glass Materials and Their Use in Packaging Systems: U.S. Regulatory Expectations

Dr Charudharshini Srinivasan

  • Legal Basis
  • Quality requirements for glass
  • Demonstration of suitability
     
 Speech

Glass Materials and Their Use in Packaging Systems: EU Regulatory Expectations

Dr Katrin Buss

  • Legal Basis
  • Quality requirements for glass
  • Demonstration of suitability
     

Day Two - 7 June 2018


 Speech

Proposed Revisions to specific Tests in USP Chapter <660>

Dr Holger Röhl

  • The presentation exhibits an overview of the current status of the tests described in chapter USP <660> and the intended changes for the revised edition
     
 Speech

Overview and developments in glass-related texts in the Ph. Eur.

Dr Ellen Pel

  • Update on Ph. Eur. activities related to Glass Containers for Pharmaceutical use
  • Revision of General Chapter 3.2.1. Glass Containers for Pharmaceutical use

 

 Speech

Different Glass Compositions for Pharmaceutical Primary Packaging – Latest developments

Dr Bettine Boltres

  • Chemical Challenges for Glass Formulations
  • Examples of Enhanced Chemical Stability
  • Challenges in the Regulatory Field
     
 Speech

Real Time Packaging Pressure Monitoring

Dr Holger Röhl

  • Introduction to a system for measuring line pressure
  • Understand the effect operational parameters have on line performance, improving efficiency, reducing wastage and minimizing downtime
     
 Speech

Special Aspects in Development of Syringes made of Glass

Frank Bamberg

  • Drug-Contact
  • Device-Functionality
  • Container Closure Integrity
  • Suitability for Processing
     
 Speech

Control of Glass Particles: Examples of Testing and Thorough Root-Cause investigations

Dr Oliver Valet

  • Visible and Sub-visible particles root cause investigations
  • Raman and LIBS investigations
  • „„FPM glass suspect in a vial
  • „„Pre-filled syringe washing optimization study
     
 Summary

USP Summary: Next Steps

Dr Bettine Boltres

 Q & A

Q & A panel session & Conference Concludes