Cleanroom Injection Moulding for medical devices

Injection moulding under cleanroom conditions to ISO 14644-1 is the key technology for single-use articles, diagnostic consumables, housings for active products and primary packaging. In practice Classes 7 and 8 predominate; Class 5 is found almost exclusively in local protective zones above critical process steps, not as a room class.

The robust selection criteria lie beneath the surface of the brochure figures. What is decisive is the class of the room in which moulding actually takes place — not the best class on the site. Equally important: do assembly and packaging take place in the same cleanroom, or does the part travel through unclassified zones? Does the provider have toolmaking in-house, which dramatically speeds up changes and maintenance? And are the materials used — PP, PE, COC, medical elastomers — backed by supplier declarations and biocompatibility data to ISO 10993?

For sterile products the chain behind this is added: sterile barrier packaging to ISO 11607 and a validated sterilisation process (EO, gamma, steam) at the provider or at a well-established service partner. The register maps precisely this chain: cleanroom class, materials, certifications and sterilisation are combinable filters — turning hundreds of injection moulders into the handful that suit the product.