Issue:March 2014

EXECUTIVE INTERVIEW – Gerresheimer: Understanding Customer Requirements

Throughout the past 2 decades, Gerresheimer has evolved into a highly specialized supplier of glass and plastic packaging products to the pharma and healthcare industry. Strategic acquisitions and the targeted further development of know-how and technologies have helped the company to position itself as one of the pharma and healthcare industry’s leading global partners. The comprehensive portfolio of products includes pharmaceutical packaging products as well as convenient and safe drug delivery systems, such as insulin pens, inhalers, ready-to-fill syringes, vials, ampoules, bottles, and containers for liquid and solid pharmaceuticals with closure and safety systems, plus cosmetic packaging products. Gerresheimer realizes revenues of more than 1.2 billion euros and has around 11,000 employees at more than 40 locations in Europe, North and South America, and Asia.

Andreas Schütte joined the Gerresheimer Group’s Management Board in 2009. He headed the Plastic Systems Division until the end of the 2013 fiscal year. Since the beginning of this new fiscal year, he has been responsible for the extended Plastics & Devices Division. He believes that know-how transfer between medical plastic systems and syringe systems experts is essential for the development of modern, practical, and patient-friendly drug delivery systems. Drug Development & Delivery recently spoke with Mr. Schütte to discuss his important role in Gerresheimer’s divisional restructuring process, and how he is convinced the new structure better reflects customer requirements.

Q: How is your division now

The Plastics & Devices Division incorporates the Medical Plastic Systems, Plastic Packaging and Syringe Systems business units. Medical Plastic Systems develops complex plastic systems and system components. Gerresheimer designs and manufactures them in the framework of individual projects, mainly for customers in the pharmaceutical, diagnostics and medical technology sectors. Medical Plastic Systems provides an individual service across all supply chain processes. The medical plastic systems range extends from inhalers for the targeted treatment of respiratory diseases, lancing devices and insulin pen systems for diabetes sufferers to a wide range of test systems and disposable products for laboratory and molecular diagnostics. Plastic Packaging’s portfolio includes plastic packaging systems for liquid and solid pharmaceuticals. Administration and dosing systems such as eye drop or nasal spray bottles and special containers for tablets and powder are some of the products in our comprehensive range of high quality primary pharmaceutical packaging. Duma brand multifunctional closures with tamper evident seals, child-safe closures, senior citizen friendly features and integrated moisture absorbers are key product features in the Plastic Packaging range. Syringe Systems supplements the portfolio with ready-to-fill syringes made of glass and plastic and the relevant accessories. Gerresheimer’s specialist expertise and pharma-compliant technologies enable it to offer high quality primary packaging products to its customers in the pharmaceutical and biotech sectors. Most of its syringe system revenue is generated today with the leading Gx RTF (Ready to Fill) brand syringes. These syringes are supplied to the pharma industry in a wide range of designs and in a ready-to-fill state after washing, siliconization, preassembly and sterilization.

Q: To what extent do
Gerresheimer’s plastics business units compete with its glass business units?

They only compete in terms of performance. Otherwise, glass and plastic complement each other with their specific properties and advantages. One of our priority objectives is to enhance medication efficiency through targeted and precise dosage, with a particularly strong focus on practical convenience and application safety. Our expert knowledge of the properties of glass and plastic in conjunction with our R&D activities help us to develop optimum solutions. One of the materials that is going to become firmly established in the market alongside glass is COP (cyclic olefin polymer). Multilayer vials, ready-to-fill syringes, customer-specific primary packaging, and microtiter plates made of COP play an important role supplementing their glass counterparts when highly active agents or particularly sensitive formulations have to be packaged. COP’s advantages are its very high break resistance and low level of drug interaction, plus its glass-like transparency. We have developed market-ready products, some in conjunction with partners, that satisfy the very highest requirements.

Q: Do you derive any
synergies from the know-how transfer between your glass and plastics experts?

There are three particularly interesting examples that demonstrate our experts’ development competence. Gerresheimer has developed innovative and safe solutions for new parenteral drugs with alkaline pH ranges or toxic pharmaceuticals. Our Gx MultiShell vial, which has an outer COP layer and a middle polyamide layer, unites the advantages of glass with the break resistance of plastic. This combination improves the vial’s oxygen barrier effectiveness to 40 times that of conventional COP monolayer vials. The COP contact surface also improves the stability of the highly sensitive medications and minimizes interaction between the drug and packaging. That’s a progressive development with genuine benefits for healthcare.

Our well-known and proven range of Gx RTF glass syringes has been supplemented with ClearJect brand plastic syringes. COP is also used for them. Plastic ready-to-fill syringes currently have an approximately 1% share of the global market (not including Japan). They are available in low-silicone oil or silicone oil-free versions; their needle mounts do not release tungsten or adhesive residue; and they are break-resistant, customizable, and have the same break loose forces, glide forces, and other functional properties as glass syringes. This heavy metal-free material is perfect as a primary packaging for sensitive medications in oncology, ophthalmology, and other fields of medicine.

We recently showcased an excellent example of Gerresheimer’s interdisciplinary collaboration, Gx® G-Fix™, at Pharmapack in Paris. Gx® G-Fix™ is a standard interface for incorporating ready-to-fill glass syringes in drug delivery devices, such as autoinjectors. It was developed due to the fact that an increasing number of glass syringes are being integrated in devices. However, integrating glass syringes in devices poses a number of challenges. The drug delivery systems have to be designed to incorporate the syringe. One problem associated with the process of inserting the actual syringe is glass breakage. We solved it by designing a standard interface for the ready-to-fill glass syringe, which simplifies its integration in the device. The advantages of this solution are simple integration, extensive prevention of in-device glass breakage, and therefore a far lower rate of product takeback. It also pays off for our customers because a standard interface minimizes the risks and costs associated with development and it can be used in combination with different devices. The technology can also be integrated in existing filling lines.

Q: In 2012, Gerresheimer
acquired a product design company. Why?

Many of the device designs that customers bring to us aren’t suitable for a cost-optimized production process, so time-consuming and expensive redesigns are necessary. We want to be involved in customer projects right from the initial idea onward. That’s why we decided to extend our pharmaceutical and medical technology product design and development competencies. Now our portfolio extends from concept development to the ready-to-manufacture product. We provide advice and support in early project phases, including services such as design development and Freedom to Operate analysis, plus engineering, prototyping, and clinical study support services as well as the production of clinic samples.

Q: What are Gerresheimer’s
strengths, in your opinion?

Gerresheimer’s strengths are customer orientation, quality, specialization, and global presence. Our glass and plastics experts are some of the best in their fields, and they understand our customers’ needs and requirements.

Q: What do your customers expect of you, and how do you ensure these expectations are met?

Most of all, our customers expect quality. We implement a two-yearly customer satisfaction survey to ensure we are aware of their specific quality requirements and equipped to meet them in the long-term. We take the results of this survey very seriously and use any negative feedback as the basis for introducing improvements. Customers who tell us what they think and enter into dialog with us are interested in developing their business with us. Customers who don’t talk to us are already talking to other suppliers about their business.

We have all the necessary quality certifications, plus the Gerresheimer Management System (GMS), a group-wide quality system we developed to help us to optimize our processes according to uniform global standards. After our first customer satisfaction survey in 2011, we developed and implemented binding quality regulations to raise the level of quality at all our production facilities around the world. They apply on a group-wide basis across all divisions and product categories, supported by key performance indicators, training, and feedback to our quality teams so that we can maintain our high standards.

One good example of our consistent implementation of these new quality standards is our new, fourth production line for ready-to-fill syringes at our Bünde production facility. It takes the production of ready-to-fill syringes into a new quality dimension. Key process improvements include the avoidance of glass-glass and glass-metal contact through the use of pick-and-place robots and segment transport systems; optimized washing and siliconization processes; and more effective, camera-based quality inspections. This gentle handling results in a lower syringe cosmetic defect rate. A state-of-the-art washing process guarantees compliance with both present-day and future regulatory requirements. Improved spraying technology and in-line inspections in the siliconization process ensure consistent syringe function. A modular assembly concept increases production capacity and makes it possible to respond flexibly to customer requirements. Complete dimensional control ensures the syringes’ filling processability. Automated in-line inspections guarantee consistent quality. All production lines are operated under cleanroom conditions, which further improve product hygiene and safety.

Q: In which markets will Gerresheimer achieve growth?

Last year, we invested a total of 120 million euros in specific growth projects. Although we already have extensive business operations in the developed markets of Europe and the United States, we believe there is further growth potential there. The IMS (Institute for Healthcare Informatics) estimates that the pharmerging countries, such as Brazil, China, and India, will be contributing 30% of global expenditure on healthcare in 2016. We’re focusing on these growth markets. In 2012, we consolidated our position in India by taking over two companies there. In Brazil, we have been the leading supplier of pharmaceutical plastic packaging products since taking over Védat in 2011. I know that Gerresheimer is ideally equipped for future growth. To take advantage of this, all we have to do is keep listening to our customers and make sure we understand their needs.

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