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Medical molding is decided by documentation as much as by hardware. The machine must hold a validated process, run cleanly, and record what happened — which is why all-electric machines dominate this segment.
No hydraulic oil in the injection unit area means no oil-contamination risk near the product; servo-electric drives give reproducible shot profiles that a validation protocol can lock; and energy use and noise drop in cleanroom environments.
| Item | What to record | Why |
|---|---|---|
| Process parameters | Shot, temperatures, pressures, cycle time per shot | Validation requires proving the process stayed in window |
| Material lots | Resin lot numbers per batch | Traceability from raw material to shipped part |
| Maintenance | Seal and screw changes with dates | Auditors expect a maintained validated state |
Medical grades of PP, PE and PC are molded with the same physics as commodity grades but with lot traceability and stricter change-control. Silicones and elastomers for medical use usually run on dedicated tooling with dedicated barrels.
No hydraulic oil near the product area removes a contamination source, and servo-electric drives hold reproducible shot profiles that a validation protocol can lock and audit.
It depends on the product class. Many components are molded in controlled environments rather than full cleanrooms; the requirement follows the customer's device classification, not the machine.
Per-shot process parameters, raw-material lot traceability, and maintenance records that show the machine remained in its validated state.