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Injection Moulded Cleanroom Components

Manufacturing in accordance with ISO class 8 (in operation) and GMP class C

We use injection moulding machines in our ISO class 8 (in operation) and GMP class C cleanroom to manufacture your product efficiently and precisely. Stronach specializes in the processing of demanding high-temperature plastics, the integration of inserts and multiple-component injection moulding.

Thanks to additional flow-box systems, processing can be achieved locally that is one class higher. Using a central drying and conveying system, the raw material is fed in directly with minimal contamination.

Injection moulding in the cleanroom

  • Injection moulding machines with closing force of 35 to 300 tonnes
  • Parts weight ranging from approx. 0.1 g to 1000  g

Wide range of equipment for processing fluoroplastics

Ready-to-sterilize

Our state-of-the-art cleanroom concept enables us to manufacture ready-to-sterilize products. Thanks to additional air and hygiene measures installed around the manufacturing cell, we are able to manufacture components using injection moulding that fulfil the requirements of GMP class C.

Plastics processing capabilities

You can take advantage of Stronach™ s expertise in the cleanroom processing of plastics in the following areas:

    • Advice on the replacement of metal components with plastic
    • Optimization and simplification of existing designs for manufacturing with plastic with the help of 3D-CAD (Solidworks) and FEM (Finite Element Method)
    • Support in the selection of appropriate materials
    • Simulation of the injection moulding process using Stronach™ tools
    • Procurement and manufacture of functional prototypes and test samples using rapid prototyping
    • Conceptual design and procurement of injection moulding tools

Manufacture to series production

Phase 1: Concept

The requirements for the new product are defined in the user specification. Design and concept variants are then created. Patent suitability is clarified and the preliminary regulatory strategy and risk and cost analyses are compiled.

Phase 2: Product development

For more detailed project planning, the user specification is developed into a performance specification. Once approval is given, product development begins. CAD data is generated and prototypes are constructed. The production process (including test planning) is planned. The marking and packaging of the product are defined.

Phase 3: Process development

In the process development phase, the tools, fixtures and models are designed, manufactured and sampled. At the same time, the qualification processes are implemented. Production guidelines are drawn up and staff are given appropriate training. The process development phase ends when the functional capability of the tools, fixtures and plant has been qualified.

Phase 4: Process proof

The proof phase starts with the design, the document freeze and commencement of change management. Process proof is provided using three validation runs. Here, 0-series production parts are manufactured and tested in accordance with the process documentation in a batch size that is similar to series production levels. If required, a larger test scope can be set up. Following validation, the product is registered and released for production.

Phase 5: Market launch

Following the final project review, the product is introduced to the market.