From the glass tube to the nested syringe: The less complicated the syringe the more demanding are the quality requirements: a lecture explains the reasons

Innumerable individual aspects determine the very conception of modern syringe systems – and even moreso their high-quality realization in every detail. At the Pharma Congress Production & Technology (March 9 – 10, 2010 in Düsseldorf), Gerresheimer Bünde examines the complex manufacturer responsibilities associated with the production of prefillable syringes: the Gerresheimer Group’s Center of Excellence, which specializes in this field, contributes to the Congress with an interesting specialist lecture and small accompanying exhibition.

In Claudia Petersen, Director of Business Development for Gerresheimer Bünde, the organizer Concept Heidelberg managed to find a highly competent speaker for this subject. Across the field of injections her company ranks among the technology and innovation leaders worldwide– particularly with the leading brand RTF® (Ready to Fill). This range of all-glass sterile syringes represents the latest status of technology from all relevant viewpoints:

• Gerresheimer supplies them to the pharma industry ready to fill from A to Z – completely preassembled, siliconised and sterilized, and additionally in tailor-made nests for fully automated filling.
   
• The syringes are based on borosilicate tubular glass which has the highest hydrolytic resistance. The tubes themselves are also manufactured by Gerresheimer in house as an intermediary product.
   
• With extremely precise PharmaPlus™ technologies for syringe forming and production, Gerresheimer Bünde has managed to develop a completely new quality category previously unattained anywhere in the world.
   
• As an alternative to the customary liquid siliconisation – especially for sensitive biopharmaceutics – the finishing spectrum offers Baked-On RTF™, a process whereby the silicone oil is fixed to the syringe wall.
   
• Innovative product labeling helps prevent mistakes and counterfeits. Laser Coding places individual data for the syringe in the glass of the finger flange. Multicolor Heat Transfer Printing makes it easier to take in the printed information and calibrations.
   
• Intelligent accessories facilitate safe handling of the syringe. These include closures such as the Rigid Needle Shield with thermoplastic elastomer (TERNS) and the Tamper Evident Luerlock Closure (TELC), or for example the Backstop with a widened finger flange.

Against this background the lecture, which is being held on the second congress day in the framework of the ready-to-fill syringe conference, may be expected to provide comprehensive information. Under the title "Prefillable glass syringes: system responsibility from the tube to the nested syringe,” Claudia Petersen’s lecture takes participants through the many requirements which advanced systems have to fulfill today – and in parallel explains the qualitatively critical spectrum of specifications, control mechanisms and process optimizations.

“The less complicated syringe systems are for the pharma industry and end users, the more demanding are the quality requirements they impose on the manufacturer,” says Burkhard Lingenberg, Director of Marketing and Communication for the Gerresheimer Group: “The market must have confidence in maximum competence and responsibility in this demanding field.”

The Gerresheimer Group
Gerresheimer is an internationally leading manufacturer of high-quality specialty products made of glass and plastic for the global pharma & healthcare industry. Our wide product spectrum ranges from pharmaceutical vials to complex drug delivery systems, such as syringe systems, insulin pens and inhalers, for safe dosage and application. Together with our partners we develop solutions which set standards and have role-model status throughout their respective business sectors. Our Group of companies achieves in Europe, North and South America and Asia sales of about €1 billion and employs around 9,400 people. Through top-class technologies, convincing innovations and targeted investments we are systematically expanding our strong market position.