Injection molding of diagnostic and medical devices

Our customers call for the smallest dimensions, the most narrow tolerances and the highest level of functionality – needs that Gerresheimer fulfills with precision injection molding. We realize tolerances in the micro-precision range from =< 10 µm and in the ultra-precision range from =< 3 µm. Our injection molded plastic parts and assembly units satisfy the highest demands for accuracy of fit – a level of quality that is indispensible for the high system requirements for diagnostic products and medical products produced fully automatically in large series.

The production of high quality diagnostic products and medical products requires an adequate production environment. With over 40 years of experience in clean room production according to ISO 14644-1 ISO classes 7, 8, 9 and GMP classes C and D, 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, 9 and GMP classes C and D.

As a global player we think and act international. Therefore, we offer our customers 120,000 sqm (1,300,000 sqft) of production area, of this around 60,000 sqm (670,000 sqft) of clean room area in accordance with ISO 14644-1 ISO classes 7, 8, 9 and GMP classes C and D  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 there. 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.

We assume responsibility not only for the assembly of plastic and metal parts, but also install the electronics necessary for the end device. Gerresheimer Medical Systems also assumes responsibility for the assembly of RFID chips, because the traceability of tests and the providing of information for the analysis device by way of the test to be carried out are continuously increasing in importance. For the assembly of electronics, we create our own clean rooms, which are also equipped with a special ESD protective floor for preventing static charge. Special camera tests in the assembly system ensure the correctly positioned insertion of circuit boards, the damage-free positioning and snap-fitting of punch parts and the correct position of switches. A gap-free in-line function test at the assembly system rounds off our range of services.

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.