Our specialties
- 2C/3C injection molding
- Cleanroom production to ISO 8 & ISO 7
- ISO 13485 for the manufacture of medical products
- Micro injection molding
- Microfluidics: Covering all stages from design to filling and packaging
Plastic Injection Molding in Medicine
State-of-the-Art Plastic Injection Molding for Medical Components
The development of medical products and components is becoming increasingly complex. In addition to external factors such as rising costs, market volatility, and increasingly stringent regulatory requirements, the transition from a product concept to a series-production article involves a multitude of process steps that must be precisely planned and coordinated. Plastics serve as a key material, meeting the highest performance and quality standards in medical technology.
Why is plastic ideal for medical components?
Plastic is the ideal material for life science and medical components. It is lightweight, highly moldable and offers great freedom in component geometry. Plastic injection molding is a particularly suitable and cost-effective process for producing plastic components. RKT has a modern, automated machine park and specialised manufacturing processes for producing plastic medical components.
Involving industry partners at an early stage
To ensure that a medical technology product reaches the point of sale without delay or additional cost, manufacturing aspects must be considered from the initial design stage and development of its functionalities:
- Which materials are suitable for the product?
- What are the hygiene conditions for production?
- What needs to be considered when designing the injection mold?
- What tolerances need to be taken into account?
- Are there any special safety requirements?
- Which process steps can be automated?
- How should the subsequent packaging logistics work?
From the outset, series production should be considered to save time and costs. If the design and functionalities do not consider requirements related to the production process—such as draft angles—subsequent adjustments to the design, materials, or processes may be necessary, resulting in additional work and costs.
Benefit from RKT’s vertical integration
From prototype to finished series product, RKT supports medical technology companies in setting up large-scale industrial production. As a development partner, RKT covers the entire value chain:
All necessary processes are defined together at an early stage: From material and design requirements to toolmaking and mold making, injection molding under cleanroom conditions, (partially) automated assembly steps, packaging and shipping.
Thanks to its comprehensive vertical integration, RKT acts as a single point of contact throughout the entire production cycle, providing expert support for every step of the process. As a customer, you benefit from over 25 years’ experience in the production of medical technology.
One point of contact for all matters:
Contact us to find out more about our range of medical technologies or to discuss your specific project.
Stefan Preis
Head of Project Business
S.Preis@rkt.de
Microfluidic Assemblies
RKT specialises in designing and manufacturing microfluidic assemblies that deliver fast, reliable analysis results in diagnostics. This requires precisely manufactured cartridges with the finest microstructures. Thanks to techniques such as precision milling and eroding, RKT is able to maintain tight tolerances to ensure that fluids and reagents are subsequently optimally guided through the channels and chambers.
Handling of lyophilizates
Lyophilizates are freeze-dried substances that have to be processed with great care. As reagents, they must be placed in the chambers of test cartridges. Since they are extremely brittle and hygroscopic, sophisticated humidity and temperature control is essential: The humidity must be kept below 50 percent, otherwise the lyophilizates would dissolve immediately. At the same time, the temperature must not exceed 25 degrees Celsius.
Multi-component injection molding
RKT has decades of experience in multi-component injection molding. This process of injection molding two or three different plastic mixtures in a single work step has many advantages in terms of saving downstream processes in assembly or, for example, creating conductivity in components. The process can also be used to achieve technical and visual advantages.
High-Cavity Tools
High-cavity tools are essential for cost-effectively producing large quantities of simple molded plastic parts. RKT produces 32- and 64-cavity tools in its in-house tool shop; 128-cavity tools are also used in large-scale production, such as for insulin needles. High precision is essential in tool production so that all cavities are identical and the subsequent injection molding process can produce the same components.
You need a complex tool, but want to produce it yourself using your company’s own injection molding?
Contact us to find out more about our range of medical technologies or to discuss your specific project.
Stefan Preis
Head of Project Business
S.Preis@rkt.de
Sealing process/ Thermobonding
Temperature – pressure – time – the thermobonding process depends on the correct coordination of all parameters in order to seal microfluidic test cartridges with a plastic film. The reagents contained in the cartridges must not be adversely affected by excessively high temperatures, nor must the internal channels be sealed in the wrong places due to excessive pressure, which would impair the fluidic function.
Cleanroom Production
Our years of experience in manufacturing medical components are complemented by our in-depth expertise in cleanroom production. Depending on requirements, all processes can be carried out under white room conditions, ISO 8, cleanroom conditions, ISO 7, or GMP standard C conditions. This includes the integration of the injection molding process, as well as the assembly and, if necessary, packaging stages. Targeted monitoring and regular staff training ensure consistently high cleanroom standards.
RKT has extensive experience in producing a wide range of medical components, each with their own specific requirements. Consequently, production conditions at RKT meet the highest quality standards.
Would you like to learn more about our cleanroom concepts and how to produce medical parts under cleanroom conditions?
Download our free white paper on plastic injection molding under cleanroom conditions
Key Factors for Injection Molding and Assembly in the Cleanroom
You set the highest hygiene standards for producing your medical components, and we implement them with a sophisticated cleanroom concept.
Our free white paper explains the challenges of plastic injection molding, subsequent assembly, and packaging in a cleanroom, as well as the processes and control mechanisms used to address these challenges.
What you’ll learn about:
- Injection molding machine concept for ISO 7
- Planning a cleanroom
- Behavior in the cleanroom
- The challenge of being analyte-free
- Special process steps: Handling of lyophilizates and blistering
- Targeted monitoring and documentation