Medical
Cleanroom injection molding
Cleanroom molding controls airborne particulate around the molding process. It is a requirement for some medical and optical parts and an unnecessary cost for many others.
What a cleanroom class means
ISO 14644 classifies cleanrooms by the maximum permitted concentration of airborne particles at defined sizes. A lower class number means fewer particles allowed. Molding is most commonly performed in Class 7 or Class 8 environments; the far stricter classes used in semiconductor fabrication are not typical for plastics.
| ISO class | Common description | Typical use |
|---|---|---|
| ISO 5 | Class 100 | Aseptic filling, not usually molding |
| ISO 7 | Class 10,000 | Medical device components in the sterile fluid path |
| ISO 8 | Class 100,000 | General medical device components, packaging |
What it involves in practice
- Filtered air. HEPA filtration with controlled air changes per hour and positive pressure relative to surrounding areas.
- Gowning and access control. Airlocks, defined garments, and documented entry procedures.
- Segregated machines. Either the whole molding cell sits in the controlled space, or the tool area is enclosed with parts dropping into a controlled zone.
- Material handling. Closed resin conveying so material is not exposed to open air.
- Cleaning and monitoring. Scheduled cleaning, particle counts, and documented environmental monitoring records.
When you actually need it
The requirement follows the device classification and where the part sits in it, not the industry the customer is in.
- Usually required: components in the sterile fluid path, implantable components, parts in direct prolonged patient contact, and some optical components where particulate would be a functional defect.
- Usually not required: external housings and enclosures, non-patient-contact structural parts, and equipment covers, even on a medical device.
What it changes about cost
Cleanroom molding costs more per part, because the environment is expensive to build, certify, and maintain, throughput per square metre is lower, and the documentation burden is real. Specifying it where the device does not require it adds cost without adding compliance, which is why the classification question should be settled before the quotation rather than after.
Filtered air enters through the ceiling, passes down over the process in one direction and leaves at floor level, so particles are carried away from the part rather than circulated. People enter through a gowning airlock. The class number states how many particles of a given size are permitted per cubic metre, and it is a property of the room in operation, not of the equipment in it.
What should come with the parts
- Environmental monitoring records for the production period
- Material certificates traceable to resin grade and lot
- Lot traceability from finished part back to production run
- Validation documentation where the device requires IQ, OQ, and PQ
- Change control, so no material or process change happens without notification
Our status
Trumould does not operate a cleanroom. This page exists so you can work out whether your part actually needs one, because the requirement is real for some medical and optical work and an unnecessary cost for a great deal else. If your part does need a classified environment, we are not the right supplier for it, and we would rather say so here than after you have sent drawings.
Let’s get started on your part
Send your CAD files and target volumes. We come back with a price, a lead time, and any design notes that would reduce either.