Clean Room Injection Molding
Some plastic parts cannot be made on an open production floor.
A component that will sit inside a medical device, contact a fluid path, or reach a patient has to be molded where airborne particles are controlled and the process is documented.
Rimoni operates two clean rooms in Kiryat Shmona and Modi’in both classified ISO 8 (class 100,000), under an ISO 13485 quality system for medical devices and hygienic parts.
Both rooms sit inside plants that also hold the engineering, tooling and assembly capabilities.
A part does not travel between suppliers to reach its finished state, which matters more in a regulated product than in almost any other kind.
What ISO 8 means in practice
An ISO 8 clean room limits airborne particles to a defined count per cubic metre the classification formerly known as class 100,000.
Air is filtered and exchanged continuously, pressure is held above the surrounding areas so air moves outward rather than in, and everyone entering gowns and passes through an airlock.
For a molded part, the practical effect is that the surfaces which will later contact a patient, a reagent or a sterile field are not exposed to the particle load of a normal factory floor between ejection and packaging.
Choosing the right classification is a design decision, not a default.
ISO 8 suits the great majority of medical device housings, fluid-path components and hygienic parts.
Where a product genuinely requires a tighter class, that belongs in the conversation early it changes cost, cycle and packaging.
Complete Manufacturing Capabilities. One Partner.
Mold manufacturing, precision injection molding, cleanroom production, assembly and automation.
Clean room capacity on its own is only half the answer.
What decides whether a medical programme runs smoothly is whether the mold, the process and the assembly were designed together and whether the people responsible for each are in the same building.
Selected Projects
Contact and further information
The Rimoni team is available for additional information, technical questions, requirement reviews, and enquiries related to development, manufacturing and service.