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Packaging Materials for Parenterals: Polymer – an Alternative to Glass?

For Immediate Release:
08/28/2013
Media Inquiries:
Georg Roessling, PhD
/ roessling@pda.org /
+49 (0) 30 43 655 08-10

Learn all about Packaging Materials for Parenterals: Polymer – an Alternative to Glass? At the Most Important Meeting of the Year!

Although Polymer as a container material for medicinal products has been accepted as an alternative to glass in certain regions and many applications, it is still not always seen as a first choice alternative for pre-filled syringes. However, development and acceptance of polymer as a packaging material has come a long way. Ten years ago, polymer was merely an exotic material for pre-filled syringes. Even though it was already well accepted e. g. in flexible bags (LVP) then, its use in prefilled syringe applications did not attract much attention.

In the last two years, however, the picture has changed dramatically. More possible applications have been presented, attracting quite a lot of interest. But still, polymer leaves many within the pharmaceutical Industry uncomfortable.

While glass syringes have a long and stable tradition, with benefits and restrictions well known, facts like breakage/ delamination and cosmetics, half-truths like permeability, extractables & leachables and costs of ownership have hindered the global market from adopting polymer pre-filled syringes as a valid and well-accepted alternative to glass. Offering new products and innovations in pre-filled polymer containers, the time is perfect now to review the current situation, evaluate the application of polymer for primary containers/pre-filled syringes and highlight possible advantages.

Two very well recognized pre-filled syringes specialists, William Dierick, Technology Development Manager at Terumo Europe N.V. and Dr. Wenzel Novak, Director pharm. R&D at Groninger & Co. GmbH, will chair a PDA Workshop in Basel on 4 November 2013 on "Polymer as a Container Material for Pre-filled Syringes” and will thoroughly discuss if Polymer is an innovative and most of all valid alternative to glass or just and expensive niche product.

When considering an alternative to glass it is essential to investigate all facts, identify possible problems and risks. The two workshop leaders will exactly do that in their workshop and discuss subjects like properties, prospects and market. They’ll look at existing systems and recent developments on polymer pre-filled syringes and even more advanced systems. They’ll share their experience with extractables & leachables and take a closer look at processing by using existing equipment or optimized equipment. William Dierick and Dr. Wenzel Novak will share their experience and give advice on getting the facts to overcome half-truths and rumors on polymers, on adopting these polymer-based systems for life-cycle management of existing drugs, and on launching new drug products in an optimized packaging configuration and will summarize the actual situation on the market, material options, concepts, benefits and retractions to using polymer syringes.

Highlights will be two interesting case studies on two established polymer systems in Japan and the USA and the experts will give an overview on available systems and upcoming polymer products. A comprehensive update on Regulatory issues regarding the usage of polymer as a packaging material for parenterals will bring this workshop to an adequate conclusion. Anyone working in development, fill-finish, quality assurance, regulatory affairs and marketing will get state-of-the-art information on polymer containers.

To counterbalance the subject packaging material for parenterals the training course "Glass – The Packaging Material for Parenterals" will be held on 7 November. The training course held by Dr. Bettine Boltres, Product Manager Pharmaceutical Tubing at SCHOTT AG, will review all aspects of "Glass - The Packaging Material for Parenterals”. Dr. Boltres will take a close look at the raw materials and production process of glass tubing, cover basics of physical and chemical properties of glass: the viscosity, coefficient of thermal expansion, chemical resistance, surface reactions, permeability, shelf life, glass breakage and defects. Drug container interactions such as extractables & leachables, pH shift, protein adsorption, lyophilization process and delamination will be analyzed closely. The glass expert will compare different types of type I glasses all around the world and will examine examples of problems like breakage or delamination and how to approach those challenges. Important regulatory issues will certainly be highlighted as well.

Both events will take place as part of the PDA Europe Conference "The Universe of Prefilled Syringes and Injection Devices - Providing Value and Compliance" in Basel, Switzerland on 5 November and 6 November 2013. The Universe of Pre-filled Syringes, has become THE must-attend meeting of the industry. Global experts will share and discuss the latest developments in all areas related to Prefilled Syringes. More than 95 exhibitors will present their latest innovations and developments in a large exhibition to approximately 600 participants from all-around the world.
Three plenary sessions will cover advances in health care, trends in pharmaceutical development and manufacturing and regulatory & compliance trends for drug devices. In six break-up sessions speakers will talk about and discuss with the participants topics like new developments, new techniques, user perspective, stoppers and elastomeric components, formulation challenges and manufacturing. Penal Discussions will give each participant the opportunity to actively discuss hot topics or to raise important questions.

Next to the above-mentioned workshop and training course, the conference will be accompanied by various training courses and an interest group meeting. The interest group meeting combination products on 4 November and the training course "Development and Technical Requirements for Combination Injection Products"on 7 and 8 November both held by Lee Leichter, President, P/L Biomedical will underline the importance of drug delivery combination products which are forecasted to become an increasing larger part of the marketplace for new drug and biologics as well as for lifecycle management, generics and biosimilars. A two-day training course on 7 and 8 November will give a holistic overview on the "Development of a Pre-filled Syringe".

The "Universe of Pre-filled Syringes and Injection Devices" is one of the most influential meetings in the industry organized by PDA Europe. The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.