Point-of-care test, injection mold, assembly, plastics
Point-of-care tests

20 years of experience in the production of point-of-care tests make us the ideal partner. Whether drug detection, pregnancy tests, detection of emergency parameters or allergy tests, whether use in the doctor's office or in the analysis device in the lab: We develop and produce your complete point-of-care test including loading of the point-of-care tests with test strips and filling of the quick test with the necessary dilution solution.

Your PLUS with Gerresheimer

Full service: from the concept development to the finished point-of-care test

Quick test, point-of-care test, injection molding, assembly, plastic parts
Point-of-care test for drug detection

Gerresheimer Medical Systems assumes responsibility for all stages of the value creation chain: from the initial concepts for point-of-care test housing made of plastics extending to the packaging of sensitive end products: Concept development, industrial design, product development, manufacturing equipment design, mold making, automation engineering, large and small series production under FDA/GMP conditions, high quality printing of the quick test housing secured through camera testing, as well as manual, semi-automated and fully automated
assembly of the housing components of the point-of-care test and of the test strips, filling of the required reagents, packaging, and international logistics. We offer our customers highly precise production, including the complicated cleaning steps in the clean room in accordance with ISO 14644-1 ISO classes 8 and 9.

Design for Manufacturing: reduction of development time

Quick tests, point-of-care tests, plastic components
Design for Manufacturing flows into the development of point-of-care tests

We develop your point-of-care test in accordance with user requirement specifications or optimize the component layout of existing customer ideas for injection molding production. The Gerresheimer Medical Systems engineers allow the Design for Manufacturing to flow into the development of new point-of-care tests made of plastics right from the beginning. For our customers this means a reduction in the development time, of development costs and of project risk, as the step of plastic-compatible optimization is dispensed with.

Optimal housing design for your point-of-care test

Quick tests, point-of-care tests, injection molding, assembly
Housing for a point-of-care test for detection of the cardiac markers troponin T and myoglobin

Upon commencement of development, we select the plastic material ideal for the test in order to ensure the flexibility of the point-of-care test. Our experts for quick tests then develop a customer-friendly housing design with simple and comprehensible handling. Optimal connection technology (snap lock, gluing or welding) and optimal functional support of the membrane (pressure points) complete the development of a user-friendly and safe point-of-care tests.

Microstructured mold parts

Quick tests, point-of-care tests, injection molding, plastics
Base plate of a cartridge for DNA/RNA analysis

We offer our diagnostics customers experience not only in micro components, but also in microstructured plastic mold parts for microfluidic test systems. The prerequisite for high quality microstructured mold parts is extremely precise molds. A component tolerance of less than 30 µm, for example, presumes mold tolerances of less than 10 µm. In our mold making section we therefore use machinery especially conceived of for this task. The removal of plastic parts following the injection mold requires a great deal of sensitivity in order to avoid damaging the fine channels.

Small series production

Small series production point-of care test, injection molding, assembly
Small series production in the clean room according to ISO 14644-1 ISO-class 8

Our Technical Competence Center (TCC) in Wackersdorf (Germany) offers its own production systems (injection molding machines, project-specific assembly systems like automated joining systems, gluing apparatus or systems for ultrasound welding) on which the quick and uncomplicated production of small series, development samples, or clinical samples of your point-of-care tests is possible at any phase of the project. The TCC possesses a clean room in accordance with ISO 14644-1 ISO-class 8, in which the entire value creation chain can be reproduced.

Product-specific production

Quick test, point-of-care test, injection molding, assembly, clean room
Filling of the dilution solution necessary for the test into a point-of-care test

In addition to the development, the injection mold and the assembly of point-of-care tests made of plastics, we offer our customers product-specific manufacturing steps like, for example, the filling of the dilution solution required for the test or the loading of the plastic housing with the test strips under climate, temperature, and humidity conditions we design for precisely this purpose. Even logistics is tailored to product-specific requirements with the subsequent transport in special vehicles. Due to the extremely high sensitivity of point-of-care tests with regard to contaminants, we offer our customers the entire production and assembly process in the clean room in accordance with ISO 14644-1 ISO class 8, including sealing in an aluminum pouch offering maximum protection prior to shipping.

Worldwide production capacities

Contract manufacturing of point-of-care tests, quick tests
Injection molding in the clean room according to ISO 14644-1 ISO class 8 in Dongguan City, China

As a global player, it is self-explanatory for us to think and act internationally. Our customers therefore have worldwide production facilities at their disposal in Pfreimd (Germany), Küssnacht (Switzerland), Horšovský Týn (Czech Republic), Peachtree City (USA), Indaiatuba (Brazil) and Dongguan City (China). With a production area of 100,000 sqm, of this around 50,000 sqm of clean room area according to ISO 14644-1 ISO classes 7, 8, and 9, as well as more than 350 injection molding machines, we are one of the leading companies in the industry.

Contact us!
Stefan Gebhardt
Sales Europe
+49 9431 639 6259
Shane Anderson
Sales North America
+1 609 369 1679
Rafael Kollofrath
Sales South America
+49 9431 639 6162
Mike Nie
Sales Asia
+86 769 8851 7100 317