Date: 26 April 2010
On April 20–22, 2010, the prestigious Jacob K. Javits Center is again the focus of the major congress and trade fair which is held annually together with Biotechnica America. Here the Gerresheimer Group (Booth 1142) provides an overview of innovative developments across a wide spectrum of primary packaging and drug delivery fields: showing the state of the art in glass and plastic applications – with a comprehensive range from bottles, vials, and ampoules right through to systems for the injection.
“In all our busines segments we see ourselves as pacemakers,” says Burkhard Lingenberg, Director of Marketing and Communication for the Gerresheimer Group. Certainly an ambitious claim – because of the very breadth of the spectrum covered by its product portfolio. It starts with pharmaceutical vials and jars made of molded glass which it offers in all suitable glass types, and continues with ampoules, vials, specialty cartridges and syringe systems made of borosilicate tubular glass which it manufactures itself in house as an intermediary product. It includes packaging systems made of plastic together with the related closure and dosage systems and ranges right through to medical plastic systems in all their complexity. This describes the fields of activity but not the numerous peaks of state-of-the-art technologies with which Gerresheimer today sets international standards across the board.
PharmaPlus™ sets a standard. The name stands for a previously unattained premium quality in tubular glass products, tailor-made for biopharmaceutics and similar sensitive pharma products. In addition to syringe systems, Gerresheimer offers vials, ampoules and cartridges in PharmaPlus™ quality. The basis is a new technological concept by which maximum precision and care of the material are achieved in forming and surface-treating tubular glass. A video film – also available here on the Internet – explains details of the unique process chain, taking the example of syringe production.
Ready to Fill as the most advanced supply form for syringes has already been the focus of attention for a considerable time – particularly with RTF® all-glass syringe systems, which once again achieve a new quality dimension with PharmaPlus™. The technologies and processes which mean that pharma manufacturers are able to fill these completely prepared sterile syringes straight-away enjoy a worldwide reputation as leaders in the field.
Particularly with its RTF® range, Gerresheimer has pioneered new methods in many regards. Baked On RTF® for example stands for a siliconisation process specially for sensitive injection substances: it exploits the advantages of long-established siliconisation but fixes the normally liquid glide-agent coating to the glass surface, and can thus substantially increase the stability of the medication in the syringe. Sustained success has for many years been enjoyed by the intelligent system accessories, namely TERNS the Rigid Needle Shield based on thermoplastic elastomer, as well as the Tamper Evident Luerlock Closure TELC and the Backstop with a widened finger flange.
Safety and convenience in application practice have been of long-standing benefit to traditional syringe segments – now synergies within the broad product portfolio go further. Two innovative processes for product identification can be mentioned here which also protect other glass primary packaging in an optimum manner against mistakes and confusion.
One of these is Laser Coding. Through this process Gerresheimer deposits the individual product ID in a scanner-readable matrix field measuring just one square millmeter in size – in the case of syringes, situated in the glass of the finger flange. The process means that the nature and origin of the product can be traced in apothecaries and clinics at any time. Multicolor Heat Transfer Printing makes a clear visual distinction between printed calibrations, product information and barcodes and allows important instructions to be color-highlighted. A welcome side-benefit for marketing is that the brand logo can be shown in the original colors.
In parallel to glass, use of the glass-clear plastic Cyclic Olefin Polymer (COP) presents interesting new possibilities, especially in demanding areas of biopharmaceutics and cytostatics. Compared with most other relevant plastic types, COP with its inert surface displays a substantially lower tendency to attract proteins for example. In addition, the heavy-metal-free plastic has high thermal and mechanical resistance. Last but not least, the properties of the material as an oxygen barrier are among the best in the plastic spectrum. Through an exciting new development Gerresheimer has enhanced these important barrier properties even further – by a significant amount.
In addition to the COP-based Clearject® sterile syringes which have already been introduced the Group presents new COP multilayer vials as a supremely innovative highlight in the world of plastic. For this purpose the product developers have combined two layers of COP with a central layer of polyamide. This enhances the oxygen barrier by a factor of four compared with single-layer COP vials. The new product range meets the most demanding requirements in terms of biocompatibility and naturally complies with the pharmacopoeia stipulations. In addition, because its design is consistently based on the ISO norm, its use in combination with standardized rubber closures and flange caps presents no problems. According to Gerresheimer the next step in the innovative process has already been taken: multilayer vials will, it says, soon also be available in sterile form and completely ready to fill.
This innovation is by the way one of many for which the market can thank internal synergies within the Group: to achieve this success, experts in injection systems from Gerresheimer Tubular Glass worked together with experts in pharma plastics from Gerresheimer Plastic Packaging. At Interphex the Plastic Packaging business unit also presents itself independently of this with smart, market-oriented developments which complement its multifaceted range of system packaging for liquid and solid medications in an up-to-the-minute way.
Tablet manufacturers who serve the American and European markets simultaneously are likely to be particularly interested in the new Duma® Twist-Off US-Seals. These closure systems represent a worldwide first and offer a critical advantage: for the USA they are supplied with an integrated packaging seal but in Europe without it. The only difference in the otherwise identical caps is on the inside, and for export fillers this means a substantial potential cost savings. Previously the foil seal prescribed for the US market meant that containers had to have their own closure types. With the Duma® solution the filling and sealing process is the same regardless of the destination: in the US version the integrated seal is pressed onto the container edge when the cap is put on – and then finally fixed in place simply by induction.
The enormous diversity of the product range for tablets, granulates and powder is equalled by the similarly varied range of packaging and application solutions for liquid and semi-liquid medications: from eye drops to nose sprays, from syrups to ointments, gels and lotions. On the basis of glass, on the basis of plastic and last but not least with useful combinations of both, Gerresheimer today covers practically all needs for high-caliber pharma packaging with a tailor-made solution. Newly developed caps and dosing cups which perfectly fit a multitude of vials and bottles made of PE and PET as well as molded glass provide an up-to-the-minute example of synergies across systems on a wide scale.
From here the synergies which the Gerresheimer Group offers today lead further into the most advanced areas of modern drug delivery. On the one hand for example it specialises in glass products for injections – but on the other hand also in complex medical plastic systems which it develops and realises as a highly innovative full-service provider in its separate customer-specific project business. In this way it is able to realise even pen systems completely in house – together with all the glass and plastic components from a single source.
About Gerresheimer
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. Smaller shares of the business are attributable to products for the cosmetics industry.
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.
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