Gerresheimer develops and produces innovative drug delivery systems and medical and diagnostic products for prestigious international customers.
From 26 September to 28 September, 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, industrialisation, 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, tool making, and special-purpose machine engineering through to small and large-scale production under the US Food and Drug Administration (FDA) / good manufacturing practice (GMP) conditions, assembly, pharmaceutical assembly and filling, sterilisation, and packaging.
Development centres and production sites
At its four global technical competence centres (TCC) in Dongguan, China; Wackersdorf, Germany; Bünde, Germany; and Peachtree City, US; 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 products are sent on for mass production. Project work performed on-site or in conjunction with the other sites includes steps such as plastic optimisation, series and equipment design, process development, project management, quality planning, tool making, automation technology, production preparation and pilot production.
Gerresheimer Medical Systems has production facilities in Dongguan, China; Wackersdorf and Pfreimd in Germany; Horšovský Týn, Czech Republic; North Peachtree City, Georgia, US; and Indaiatuba, Brazil.
Manufacturing medical systems made from plastic in China
Gerresheimer’s production site in Dongguan City near Hong Kong offers a full range of injection-moulding techniques under ISO class 8 cleanroom 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 4,200m2 of the site’s 10,700m2 is given over to production, including 600m2 of cleanroom in accordance with ISO class 8 (100,000) and 1,100m2 of other cleanroom 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.
Gerresheimer Medical Systems’ full-service package encompasses development, industrialisation, and production.