Prague, Czech Republic
Course No 15493
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The aim of this conference is to provide up-to-date knowledge about protective packaging solutions for the stability of pharmaceutical and cosmetic products, and foodstuff (Barrier Packaging). Which physical fundamentals are relevant? Which measuring procedures and methods do exist? Which drying agent systems are used? Which options in terms of protective packaging (blisters, bottles, tubes, vials, and syringes) in relation to the dosage form (solids, liquids, semi-solids) and the route of administration (oral, parenteral, and topical) exist, all these questions will be answered and practical case studies will be presented.
Pharmaceutical and cosmetic products and foodstuff have to be packaged in container-closure systems that protect them from factors that can endanger the stability of the product. Moisture permeation/barrier packaging and container closure system integrity is a constant challenge and a regular work stream for expert groups like 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 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, USP recently revised 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”, “tight”, and “hermetic” 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, the scientific understanding of the most important parameters helps to identify critical quality attributes and to define a “design space” which is in line with increasing demands of Quality by Design (QbD).
This course is especially designed for members of staff and executives from the pharmaceutical industry working in the field of research and development, regulatory affairs, quality control, incoming goods control of packaging materials, quality assurance, production and packaging. It is also directed at employees of suppliers manufacturing packaging materials for the pharmaceutical or cosmetic and foodstuff industry.
Introduction: The Importance of Protective Packaging