Drug Delivery Partnerships, 22 to 24 January 2007 in Las Vegas

During the specialist congress entitled 'Drug Delivery Partnerships' to be held from 22 to 24 January 2007 in Las Vegas (US Federal State of Nevada), pharmaceutical and medical practitioners will have an opportunity to obtain detailed information about this. As a highly innovative systems specialist the Gerresheimer Group is presenting sterile RTF® syringe systems from its competence centre Bünde in a package complete with highly-sophisticated accessories: particularly in everyday injection practice, it is becoming clear that the Ready-to-Fill category provides a quality and performance spectrum which has been impressively confirmed by the market. In parallel, the new subsidiary Gerresheimer Wilden makes a noteworthy debut at the congress with inhalers which are used to supply a wide variety of substances to the lungs. Wilden has belonged to Gerresheimer since the start of this year and now makes the Group the top international specialist in plastic systems as well.



With its RTF® syringe systems Gerresheimer has for many years enjoyed a reputation as the technology leader and is achieving dramatic growth rates in all five continents. The Group has again just doubled its production capacity in this area - “a simple necessity in view of market developments” in the words of Burkhard Lingenberg, Director of Corporate PR and Marketing for the Gerresheimer Group. The volume of syringes which it delivers to the pharmaceutics industry completely ready to fill, i.e. sterilised, siliconised and preassembled, will for the first time therefore exceed the volume of traditional bulk-ware systems. And with really useful convenience enhancements the success record of sterile syringes continues to climb off the chart.



The basic advantages for the pharma industry are a powerful argument in themselves. Many established pharmaceutics manufacturers have already converted their operations to the leaner processes which reduce their filling and packing costs to a fraction of what they used to be, Newcomers to the sector can usually save themselves the cost of plant construction right from the start. Through pharma-compliant technologies, related competence and producer responsibility, system partners like Gerresheimer have for some time removed any room for doubt about their unrestricted performance in this field.



Additional growth impetus has now been given to the RTF® family by practice-oriented additions - ranging from pain-saving precision needles to the Backstop – which serve to enhance application safety in a variety of ways and also extend the range of application possibilities generally. "We concentrate our research and development efforts on clear market needs,” says Lingenberg: “The concrete results today make 'Ready to Fill' a synonym for progress in terms of practical benefits.” Some information about the highlights in Las Vegas:



• Sterile COP syringe systems have recently been added by Gerresheimer to its previously all-glass RTF® range. This new plastic range is presented to the specialist public for the first time at the congress in Las Vegas. COP (Cyclic Olefin Polymer) is a crystal-clear material characterised by high mechanical and thermal stability, chemical neutrality and barrier properties which are unique for plastic. The new systems, which are particularly well-suited for highly sensitive medicines and large filling volumes, are primarily intended for use as depositary solvent syringes for freeze-dried injection materials and as highvolume contrast-material syringes in diagnostic radio technology.

• The Tamper Evident Luerlock Closure (TELC) has been confirmed as particularly attractive for users in a market survey of 110 doctors, nurses and patients which is presented by Gerresheimer in the context of the exhibition. The study confirms that the closure system – a casting consisting of two elastomers and combining the tamper-evident Luerlock twist-closure with the needle adapter – has significant benefits in practice by comparison with the traditional tip caps. For two thirds of the respondents, the key criteria were as follows. Unnoticed opening of the syringe is impossible; when the closure is twisted open there is (unlike the tip cap) no spillage; the syringe remains safely and reliably closed until it is used and with TELC is easier to handle overall. Details about this survey are contained in an information sheet which can be found on the Internet under www.gerresheimer.com.

• The Rigid Needle Shield (RNS) has received another prestigious award. For this needle protection cap, Gerresheimer has – in addition to the 2006 German Packaging Prize –been awarded an up-to-the-minute 'WorldStar' from the World Packaging Organisation. This globally coveted prize was in recognition of the clever dual function of this accessory which not only protects the needle against damage by means of an elastic plastic shield but also prevents needle-prick injuries after use by means of an impenetrable shell. The jury of international experts rated both the concept and the design and implementation as an exemplary innovation.



Outside the syringe segment, Gerresheimer has increased its attractiveness as a packaging and systems specialist in the field of pharmaceutics and medicine through the recent acquisition of Wilden AG (today: Gerresheimer Wilden), the European market leader in the field of plastic systems with an equally high profile as a high-calibre development and production partner in the segments of pharmaceuticals, diagnostics, medical technology and consumer healthcare. Gerresheimer thereby acquires an additional innovative systems spectrum with highlights ranging from inhalers and pen systems to a comprehensive catalogue of diagnostic products in thediabetics field.



It therefore caters for all types of drug delivery, with particular focus on pulmonary agent introduction. The particular know-how of Gerresheimer Wilden in the special field of inhalation, whose market importance is growing at an increasing rate in more-and-more widely diversified directions, covers all system categories. In Las

Vegas the company is exhibiting the latest developments in powder inhalers, capsule inhalers and nebulisers as well as rhinological spray systems.



As customary with Gerresheimer, the new subsidiary’s project business covers all parts of the value-added chain. This extends from product development right through to the CE-labelled product ready for sale. In addition to product development plus FDA- and GMP-compliant, large/small series production in clean rooms, Gerresheimer Wilden undertakes the entire engineering work and manufacturing of tools and special machinery. In addition, it caters for all finishing possibilities as well as manual and partly or fully automated assembly. Packaging and logistics complete its service spectrum.



All in all, the Gerresheimer Group now offers its partners a completely new service dimension in the systems sector. As a global pharma partner it also assumes a new order of magnitude, today manufacturing in more than 31 locations in America, Europe and Asia and enjoying a leading position in all the fields in which it operates.