Please note that the Programme is continuously updated - check back at a later date for more Information.
Day one - 6 June 2018
Introduction to the ECA Foundation, the Ph. Eur. and the USP
ECA introduction (Dr Andrea Kühn)
EDQM introduction (Dr Ellen Pel)
USP introduction (Dr Michael Eakins)
Overview of Key Issues for the Revision of USP Chapters <660> and <1660>
Dr Michael Eakins
Update from the <660> Expert Panel: Review of the revision process for USP General Chapters <660> and <1660>
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
Specific Aspects for Glass Containers made of Molded Glass
Kevin McLean
Overview of process and products for molded glass
Overview of ISO Modifications in relation to molded glass
Specific Defect Evaluation Lists
Type II Glass: the other parenteral container
Glass Delamination
Horst Koller
What is delamination
What is the route cause
Contribution to delamination
How to avoid
How to control
Extractables from Glass
Dr Claudia Heinl
Glass types: Differences in composition
Chemical and physical properties
Potential Extractables & Leachables from glass
Risk Evaluation of Elemental Impurities (EIs) from Glass
Dr Jörg Zürcher
Elemental Impurities acc. to ICH-Q3D
Risk evaluation
Concepts to avoid extraction of EIs
Glass Materials and Their Use in Packaging Systems: U.S. Regulatory Expectations
Dr Charudharshini Srinivasan
Legal Basis
Quality requirements for glass
Demonstration of suitability
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
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
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
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
Control of breakage in filling lines by using an innovative pressure monitoring technology
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
Special Aspects in Development of Syringes made of Glass
Frank Bamberg
Drug-Contact
Device-Functionality
Container Closure Integrity
Suitability for Processing
ICG-TC12 advices for a proper autoclaving cycle to measure the hydrolytic resistance
Daniele Zuccato
Hydrolytic resistance testing according to the Ph. Eur. and USP prescription: Differences in results due to the autoclaving cycle
How to improve the reliability of compendial autoclaving testing
Target: Produce a common document to be shared with Pharmacopeiae Authorities (E.U. and U.S.)
Control of Glass Particles: Examples of Testing and Thorough Root-Cause investigations
Dr Oliver Valet
Visible and Sub-visible particles root cause investigations
