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Christa Jansen-Otten and Dr. Heike Kofler will moderate the ”Prefillable Glass Syringe and the Appropriate Pharmaceutical Rubber Components: Processing, Packaging, Innovations,” at the 53° SIMPOSIO AFI in Rimini, Italy, on June 12-14, 2013.
The workshop will be led by West and Nuova Ompi, a subsidiary of the Stevanato Group, the world’s leading manufacturer of containers from glass tubing. It will focus on prefillable glass containers and pharmaceutical rubber components for prefillable glass systems.
Workshop participants will discuss three areas:
Manufacturing operations of glass syringes and elastomeric components
Finishing, sterilization and packaging of primary packaging components
Packaging developed for biotech/sensitive drugs and auto injectors
The group will discuss manufacturing operations and special technologies, including special coatings and elastomeric components used for prefillable syringes. Videos and samples demonstrating different production steps will help participants understand different processes. The second section will address the availability of different packaging options for elastomeric plungers for ready-to-use systems, and will further outline the different sterilization treatments available for plungers.
Pharmaceutical companies are challenged to find consistent, reliable, high-quality solutions that are manufactured with the goal of meeting their needs and the needs of their patients. Therefore the last section will focus on high-quality prefilled syringe packaging components developed for biotech and sensitive drugs as well as for auto-injector applications. The discussion will focus on the West NovaPure® component line, which was designed using a Quality by Design development process. A formal design history file will be presented.
For more information or to register for the workshop, visit http://afiscientifica.it/dettaglio.php?user=&pwd=&id=461&operazione=&page_name=&id_tipo=E&id_padre=&id_oggtipo=0&filtro= (Italian language site)
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Drug delivery via cartridge-based systems has been around for many years, with traditional applications being for the dental and insulin markets. These traditional markets will continue to maintain much of the volume for cartridge-based systems in the future; however, there is an increasing trend toward other therapeutic classes of drugs, such as those that treat auto-immune diseases, that never used cartridges before. This trend, along with the projected growth in the insulin market, indicates substantial overall growth in the cartridge space over the next several years. This Blog discusses the issues driving these trends and the West product portfolio in the cartridge market.
We are pleased to announce that Iris Bavaj, Senior Director, Quality Operations, Europe, has been recognized by the <a href="http://www.hbanet.org/"><span style="text-decoration: underline;">Healthcare Businesswomen’s Association </span></a>(HBA) as West’s 2016 Luminary.
Microneedles have been around for the past two decades; however, recent advances in technology have enabled their manufacturing in a variety of different forms and at lower cost than previously possible. The technologies, ranging from hollow, solid, coated to dissolving, have captured the interest of many vaccine and drug manufacturers as an alternate form of delivery primarily due to the potential advantages associated with transdermal and intradermal delivery.<br />
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
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