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Polymer: An Alternative to Glass?

Although polymer as a container material for medicinal products has been accepted as an alternative to glass in certain regions and in many applications, it is still not always seen as a first choice alternative for pre-filled syringes.

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 at that time – for example in flexible bags containing large volume parenteral solutions – its use in pre-filled syringe applications did not attract much attention.

The Best Material?

In the last two years, however, the picture has changed dramatically. More possible applications have been presented, which has attracted a lot of interest. Still, despite this, polymer leaves many within the pharmaceutical industry feeling uncomfortable.

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

Pro-Polymer

Two very well-recognised pre-filled syringe specialists, William Dierick, Technology Development Manager at Terumo Europe N.V., and Dr Wenzel Novak, Director of Pharma R&D at Groninger & Co, will chair a workshop at the Universe of Pre-filled Syringes and Injection Devices on 4th November on ‘Polymer as a container material for pre-filled syringes’. They will discuss whether polymer is an innovative and, most of all, valid alternative to glass, or just an expensive niche product.

The two workshop leaders will debate subjects including properties, prospects and market. They will look at existing systems, comparing them to recent developments on polymer pre-filled syringes and more advanced systems. The presentation will share their experience in extractables and leachables, as well as taking a closer look at processing via existing equipment versus optimised equipment.

Dierick and Novak intend to examine the facts regarding polymers in order to overcome half-truths and rumours, before advising on adopting these polymer-based systems for lifecycle management of existing drugs, and on launching new drug products in an optimised packaging configuration. They will summarise the true situation within the market today, material options, retractions, concepts and benefits of using polymer syringes.

Two recent case studies on established polymer systems in Japan and the US will be featured in the presentation, and the speakers will provide 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 a conclusion.

Anyone working in development, fill-finish, quality assurance, regulatory affairs and marketing will come away with state-of-the-art information on polymer containers.

Pro-Glass


To counterbalance this focus on polymer packaging, the training course ‘Glass – the packaging material for parenterals’ will also be held on 7th November. This course, led by Dr Bettine Boltres, Product Manager of Pharmaceutical Tubing at SCHOTT AG, will review all aspects of glass as being, in her opinion, the most suitable material for parenteral containment.

Boltres will take a close look at the raw materials and production process of glass tubing, and cover the basics of the physical and chemical properties of glass: its viscosity, coefficiency with thermal expansion, chemical resistance, surface reactions, permeability, shelf-life, glass breakage and defects. Drug container interactions – such as extractables and leachables, pH shift, protein adsorption, lyophilisation process and delamination – will also be analysed.

The glass expert will compare different varieties of type 1 glass around the world, before examining examples of problems like breakage or delamination and how to approach those challenges. Important regulatory issues will be highlighted too.

Parenteral Innovations

Both the workshop and the course will take place as part of the Parenteral Drug Association (PDA) Europe conference, The Universe of Pre-filled Syringes and Injection Devices – Providing Value and Compliance, being held in Basel, Switzerland, on 4th-8th November. Global experts will share and discuss the latest developments in all areas related to pre-filled syringes. More than 95 companies will present their latest innovations and developments to some 600 participants from all around the world in the supporting exhibition.

The conference will feature three plenary sessions covering advances in healthcare, trends in pharmaceutical development, plus manufacturing, regulatory and compliance trends for drug devices.

In six break-up sessions, various speakers will present on – and will debate with participants about – topics such as new developments, the latest techniques, user perspective, stoppers and elastomeric components, formulation challenges and manufacturing. Panel discussions will give each participant the opportunity to actively challenge hot topics or to raise important questions.

Alongside the above-mentioned polymer workshop and glass training course, the conference will be accompanied by various other features. The interest group meeting ‘Combination products’ on 4th November and the training course ‘Development and technical requirements for combination injection products’ on 7th and 8th November, both held by Lee Leichter, President, P/L Biomedical, will underline the importance of drug delivery combination products. This topic is forecast to become an increasingly larger part of the marketplace for new drug and biologics, as well as for lifecycle management, generics and biosimilars. In addition, a two-day training course held on 7th and 8th November will give a holistic overview on the ‘Development of a pre-filled syringe’.

Industry Presence


The Universe of Pre-filled Syringes and Injection Devices, organised by PDA Europe, has proved over the years to be an influential industry event. 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 non-profit organisation, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its 9,500 members worldwide. It is a recognised authoritative voice and technical organisation in the field of parenteral science and technology. Through the development of technical reports and responses to regulatory initiatives, PDA and its members aim to influence the future course of pharmaceutical product technology.

To be part of the debate, and to find out more about both glass and polymer materials in parenteral applications, join us in Basel, Switzerland on 4th-8th November 2013. For more information, visit https://europe.pda.org/ups2013

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Michael Betz is Drug Product Technical Owner for three major commercial biologics that are marketed as pre-filled syringes by the Janssen Pharmaceutical Companies of Johnson & Johnson. He holds a PhD in Molecular Biology and Biophysics from the Swiss Federal Institute of Technology, Zürich, and studied Chemistry at the University of Konstanz. Over the last 20 years, Michael has gained a wealth of experience within the industry, covering most aspects of protein handling and transferring biotech products into commercial manufacturing. He is Conference Co-Chair for The Universe of Pre-filled Syringes and Injection Devices.
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