Worldwide production and cleanroom capacity
Seven days a week, day and night: We are producing medical plastic systems with millions of parts nonstop with fully automated production and assembly facilities worldwide - always quick, cost-efficient and with consistently high quality. Prior to the start of production, the setup of the systems is simulated in order to set up the sequence of individual production steps economically and efficiently – short routes for production are the goal.
The full service of Gerresheimer Medical Systems encompasses much more than 100% quality injection molding. It includes many different post-production processing methods – from completion and assembly of modules to optical, haptic and functional finishing through to filling, sealing and packaging of ready-to-use systems. We even take care of the procurement of high-quality external parts and assume responsibility for the surface decoration.
The production of high quality drug delivery systems, medical and diagnostics products requires an adequate production environment. With nearly 40 years of experience in clean room production according to ISO 14644-1 ISO classes 7, 8 and 9, and coverage of the entire value creation chain in the clean room, we are your specialist for clean room production.
In order to fulfill the strictest requirements for cleanliness, we don't interrupt the cleanliness chain during production. The entire value creation chain, from precision injection molding in large and small series production through product refinement, fully automatic, semi-automatic and manual assembly of plastic parts, assembly units and metal parts extending to the testing and packaging takes place in the clean room according to ISO 14644-1 ISO classes 7, 8 and 9. We develop production concepts specific to the product that are specially tailored to the quality claims of the pharmaceuticals and medical technology branches. For example, for the production of an inhaler we have created a room-in-room concept with which we avoid the occurrence of particles caused by moving parts like feed pipes by way of an encapsulated injection molding machine.
As a global player we think and act international. Therefore, we offer our customers 110,000 sqm (1,184,000 sqft) of production area, of this around 50,000 sqm (540,000 sqft) of clean room area in accordance with ISO 14644-1 ISO classes 7, 8 and 9 in Germany (Pfreimd and Bünde), the Czech Republic (Horšovský Týn), North Macedonia (Skopje), the USA (Peachtree City, near Atlanta), Brazil (Indaiatuba, near São Paulo) and China (Dongguan City, near Hong Kong).
We of course meet with our customers "on location". For example, we have set up a complete production facility for a leading pharmaceuticals company in the diabetes field in Indaiatuba (Brazil). Plastic parts and assembly units for insulin pens are produced there in the clean room according to ISO 14644-1 ISO class 9 and then delivered to the nearby production facility of the customer. Final assembly and the filling of the cartridge with the active ingredient then takes place here. With Gerresheimer Medical Systems, you decide in favor of a flexible company with short decision paths that focuses on the wishes of customers in its thought and actions.
Our core competence is in fully automatic large series production and in the manual and semi-automatic small series production of complex and technically sophisticated systems consisting of many individual plastic and purchased parts. The combination of plastic and metal for cannulas for implants, for needles for lancets and lancet magazines, or for springs for drive elements of inhalers are just as much part of our know-how as the production of the smallest parts in high-cavity injection molds.
Extending beyond injection molding, we also procure the required purchased parts and, as an expert for the combination of plastic and metal, also assume responsibility for the purchasing of all electronics for end devices upon request. For example, we can acquire electronic counters for inhalers for the dosing, atomization actuators and the most varied sensors. We purchase RFID chips for tracing with disposable items in the lab, punch contacts and circuit boards, which are then constructed as switches, for example. Our international purchasing team procures springs for drive elements, cannulas for implants and needles for lancing devices. In the process we make use of strategic partners who are subject to regular quality audits and fulfill our strict requirements without exception.
Top performances in production are no longer possible today without high performance data processing. We therefore control and monitor production throughout the company with an internationally uniform Manufacturing Execution System (MES). Automated quality tests coupled with the production process and completely documented traceability ensure that all products correspond to the required quality standard.
