Across-the-board competence in two major packaging materials for pharmaceutics

As the flags fly for PharmTech at Moscow’s Crocus Expo Center, a high level of attendance by a technologically interested public can be expected: this year again the Gerresheimer Group presents a wealth of new ideas. From 25 to 28 November 2008 this highly specialised packaging and systems specialist is exhibiting a uniquely wide range of glass and plastic products for the pharma industry. In parallel it offers a talk which examines the widely varying requirements to be fulfilled by modern primary packaging made of pharmaceutical glass (Pavilion 2, Hall 7, Stand B51).

With the highest competence in both the major materials for pharma packaging and a comprehensive product spectrum the Group today has an international lead. In glass alone the range extends from syringe systems to cartridges, from vials to ampoules, from bottles and jars to technical-chemical containers. It also comprises both tubular and moulded glass and offers all the relevant glass categories. In the again expanded segment of plastic it offers a wide variety of containers and innovative system approaches – complemented by complex medical plastic systems such as, for example, inhalation devices, which Gerresheimer develops and manufactures in its individual project business. “This combined glass and plastic competence not only widens our range but also creates  valuable additional synergies,” says Burkhard Lingenberg, Director of Marketing and Communication for the Gerresheimer Group. As an example he quotes insulin pens: this type of combination product using specific glass cartridges and functional plastic components can today be realised by Gerresheimer completely in house.

Interesting innovations are for example displayed in Moscow for syringe systems – in itself a wide product range. This year the key focus is again on RTF® (Ready to Fill) systems which Gerresheimer supplies to the pharma industry already siliconised, assembled and sterilised, i.e. completely ready for filling. Evidently a successful  concept: in a few weeks’ time the Group is commissioning the third production line for RTF® syringes in its technology park in Bünde after doubling capacity just last year. The additional refinements in the range are also right up the minute.

In the wide choice of syringe accessories an important place continues to be taken by intelligent complementary systems for increased safety. The Rigid Needle Shield (TERNS) - a needle protection device made of thermoplastic elastomer with a rigid shell – reduces the risk of injury from needle pricks. The Tamper Evident Luerlock Closure (TELC) – a twist-off syringe closure - prevents spillage of the injection fluid during opening. The Backstop facilitates use through a large finger rest and secures the plunger at the end of the syringe when the solvent is drawn in for dry medications.

With heat transfer printing Gerresheimer has also created an economically attractive possibility for multi-colour printing on the glass, which means that syringes not only create a better-quality impression but above all are also safer. Visual separation of the multiplicity of different information types in a tiny space facilitates comprehension: brand and product names, bar codes, use-by dates and calibrations stand out clearly from each other.

Barely visible to the naked eye and readable only by scanners a new type of laser encoding gives syringes a practically indelible identity label. Deposited on a single square millimetre of the surface of the finger rest it provides exact information about the nature and origin of the product whenever required. The code provides secure track-and-trace evidence as currently under discussion by the EMEA (European Medicines Agency) and the FDA (Federal Drug Association).

Gerresheimer’s own process of baked-on siliconisation has been patented in Europe and the USA. It fixes the silicone oil – the familiar and well-tried material used to allow the syringe plunger to glide over the glass more smoothly – almost completely to the glass surface. This largely prevents interactions with for example sensitive protein-based therapeutic substances, thus increasing long-term stability particularly in the case of biotech drugs. 

From developments like these completely different forms of packaging also benefit of course. Multi-colour printing for example is of equal use for vials, ampoules and cartridges as is laser encoding – further extended by the option of baking text onto the glass. In Moscow, Gerresheimer exhibits vials where the product name is prominently laser-baked onto the base. In clinics, doctors’ practices and pharmacies, in nursing homes and in the case of home medication, this method of identification helps to avoid product mix-ups – even if a label gets lost.

The requirements which generally have to be fulfilled today by pharma glass containers, the stipulations of the supervision authorities and the additional demands created by biopharmaceutics for example are examined in a specialist talk by Claudia Petersen, Director of Business Development with Gerresheimer Bünde, entitled “State-of-the-art pharmaceutical glass containers”. All these requirements are placed by this expert in the direct context of the latest discoveries and technologies as a helpful route-finder through the increasing maze of products on the market.

Convenience in perfection characterises the range of plastic packaging which, with a great variety of shapes and wide choice of closure and dosage options, is tailored for both solid and liquid medications. Here again Gerresheimer follows the principle of supplying everything to the pharma industry as far as possible from a single source – which applies not only to the diversity of products offered but also to the composition of individual products. An excellent example of this is the Duma® range of desiccant closures which Gerresheimer manufactures completely in house for its tablet containers: including the desiccant capsules.

Valuable additional synergies and a substantial expansion of the product spectrum result from the integration of new companies which Gerresheimer acquired around a year ago. A completely new dimension has for example been achieved in the field of pharmaceutical PET bottles: the Spanish-Argentinean company EDP (today Gerresheimer Zaragoza, Valencia and Buenos Aires) – a market leader specialising in this segment– has contributed a comprehensive range of these containers to the portfolio. In parallel, the Brazilian company Allplas Embalagens (today Gerresheimer Plásticos São Paulo) has contributed a host of high-calibre containers and userfriendly packaging systems to the innovative range. In total, the Gerresheimer Group therefore already has forty plants in Europe, America and Asia. And in the plastics sector as well it has now grown to become a complete service provider for the pharma & life science industry.