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5 Dec 2013

Protective Packaging Solutions for Pharmaceutical Product Stability

The challenge for pharmaceutical packaging systems is medicinal product protection. ECA's Course Protective Packaging Solutions for Pharmaceutical Product Stability from 28–29 January 2014 in Berlin, Germany, will show how to improve drug stability through barrier packaging and desiccants. Practical case studies will be presented for specific packaging types and dosage forms. 



Torsten Kneuß, Bayer Pharma AG, Germany
Dr Mayk Kresse, Bayer Pharma AG, Germany
Horst Koller, Schott Schweiz AG, Switzerland
Dr Jörg Zürcher, Bayer Pharma AG, Germany
Prof Dr Ursula Probst, Stuttgart Media University, Packaging Technology, Germany



The aim of this conference is to provide up-to-date knowledge about protective packaging solutions for the stability of pharmaceutical drug products (Barrier Packaging). Which physical fundamentals are relevant? Which measuring procedures and methods do exist? Which drying agent systems are used? By means of specific packaging types and dosage forms (blister, oral, parenteral), all these questions will be answered and practical case studies will be presented.


Moisture permeation/barrier packaging and container closure system integrity is a constant challenge and a regular work stream for expert groups such as the Product Quality Research Institute (PQRI) or the Parenteral Drug Association (PDA).


Moisture permeation is a common challenge that can impact the quality of the drug product, so having a more accurate and reproducible method to determine how effective the packaging is at keeping moisture out will be a benefit to industry. Accordingly, also USP is currently revising the packaging and moisture permeation chapters (USP General Chapter <671> Containers — Performance Testing) to include a new method for determining moisture permeation for high and low barrier pharmaceutical packaging. USP is also considering changing the USP classification system for packaging, which is limited so far to “well-closed” and “tight” containers.


Today, the appropriate packaging system is commonly chosen on a "trial & error" approach (orientating stability investigations under stress conditions). However, this "procedure" shows its limits when no appropriate packaging has been identified within this trial & error approach. Hence, only precise knowledge of the physical processes of permeation in conjunction with the material features of the packaging and the protection requirements of the dosage form will finally provide a scientific rational for the selection of the best packaging system with optimal product protection.


Moreover, regarding new regulatory options (ICH Q8), scientific understanding of critical parameters is required - for example to be able to identify critical quality attributes and to define a Design Space.

Please see the programme for further information.

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