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Gerresheimer at Medtec China: order processing, industrial-scale production, and contract manufacturing from a single source

, Gerresheimer AG

Gerresheimer develops and produces innovative drug delivery systems and medical and diagnostic products for prestigious international customers. From September 26 to 28, the full-service provider will be showcasing its range of services at booth H401 in hall 2 of the Medtec China trade fair, which will be hosted at the Shanghai World Expo Exhibition center.

Gerresheimer Medical Systems will be using Medtec China as an opportunity to present itself as an international development, industrialization, and production partner for the mass production of injection-moulded plastic components. The company is responsible for every step of the value chain, from planning through to getting the CE- marked product ready for sale. These steps range from concept development, industrial design, product development, equipment design, toolmaking, and special-purpose machine engineering through to small- and large-scale production under FDA/GMP conditions, assembly, pharmaceutical assembly and filling, sterilization, and packaging.

Development centers and production sites

At its four global Technical Competence Centers (TCCs) in Dongguan (China), Wackersdorf (Germany), Bünde (Germany), and Peachtree

City (U.S.), Gerresheimer prepares plastic medical systems such as insulin pens, inhalers, lancing devices, and auto-injectors for industrial-scale production. The TCCs pool together all of the key cross-divisional functions before the product is sent on for mass production. The project work performed on site or in conjunction with the other sites includes steps such as plastic optimization, series and equipment design, process development, project management, quality planning, toolmaking, automation technology, production preparation, and pilot production.

Gerresheimer Medical Systems has production facilities in China (Dongguan), Europe (Wackersdorf and Pfreimd in Germany andHoršovský Týn in the Czech Republic), North America (Peachtree City), and South America (Indaiatuba, Brazil).

The Dongguan site: Manufacturing medical systems made from plastic in China itself
Gerresheimer’s production site in Dongguan City near Hong Kong offers the full range of injectionmoulding techniques under ISO class 8

clean room conditions as well as assembly, product finishing, and packaging. Project management, the validation of customers’ tools, and a tool maintenance and repair service complement the offering. An impressive 4,200 m2 of the site’s 10,700 m2 is given over to production, including 600 m2 of clean room in accordance with ISO class 8 (100,000) and 1,100 m2 of other clean room space. Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA- inspected Medical Device Manufacturer. During the Pre-Approval Inspection (PAI), the management system was audited along with the entire product manufacturing process, from incoming goods to outgoing goods.

About Gerresheimer

Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers. With our plants in Europe, North America, South America, and Asia, we generate revenues of approximately EUR 1.4 billion. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles, and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

, Gerresheimer AG

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