Injection molding of drug delivery devices
Worldwide production and cleanroom capacities
For over 70 years now, Gerresheimer Medical Systems has been producing injection molded plastic parts and assembly units of the highest quality for use in drug delivery systems. Sustainable drug delivery systems unite a plus in functionality and design quality with optimized production costs – a performance that is only possible through innovative production technologies. This is why Gerresheimer offers modern injection molding technologies such as multi-component injection molding, insert molding, micro injection molding, thin wall molding and much more. Gerresheimer was thus the first plastic processor in the world to use turning stack mold technology for manufacturing an inhaler.
Your PLUS with Gerresheimer
Precision injection molding
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 drug delivery systems produced fully automatically in large series.
Over 40 years of experience in clean room production
The production of high quality drug delivery systems, 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.
Cleanliness along the value creation chain
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.
Worldwide production and clean room capacities
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 meet with our customers "on location"
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.
Procurement of purchased parts and electronics
We assume responsibility not only for the assembly of plastic and metal parts, but also install the electronics necessary for the end device. In the case of inhalers, for example, we install the electronic counters for dosing, atomization actuators and the most varied sensors. We integrate punch contacts and install circuit boards, which are then, for example, designed as switches. 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.
Uniform manufacturing execution system
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.