Medical and precision component moulds.
Medical work is not about exotic steel. It is about proving the same dimension, on the same cavity, over and over — and being able to show the record a year later.
The document matters as much as the tool.
A 16-cavity pipette or syringe-barrel tool lives or dies on cavity-to-cavity consistency. If one cavity runs 0.03 mm out, the moulder either sorts parts or loses the order. We balance the runner, keep the cooling symmetric cavity to cavity, and number every cavity so the measurement report can be read cavity by cavity instead of as an average.
Tight tolerance also changes the tool-making process: the cavity is machined, measured, and only then finished. We work to ±0.01 mm on critical features where the drawing asks for it, and we tell you honestly when a tolerance belongs in the moulding process rather than the steel.
Documentation is part of the deliverable. Every medical tool ships with material certificates for the cavity steel, the dimensional report with cavity numbering, and the process sheet from the trial. If your quality system needs a specific format — a PPAP-style package, an FAI report per AS9102, a CPK study on nominated dimensions — say so at order stage so it is built into the schedule.
Precision, repeatably
Most medical tools we build are 4 to 32 cavity, hot runner, running engineering resins at tight cycles. Cavity numbering, symmetric cooling and a balanced runner are non-negotiable; polishing and coating follow the resin.
- Cavity steel: S136 ESR as standard, H13 for abrasive or high-temperature resins such as PEEK.
- Runner: fully balanced, hot runner with individual tip temperature control on small parts.
- Cooling: symmetric cavity to cavity, verified by flow-rate measurement on assembly.
- Ejection: sleeve or stripper, positioned to avoid marking sealing or sliding surfaces.
- Surface: mirror polish, or DLC / chrome coating for abrasive or sticky resins.
- Traceability: cavity numbering stamped, steel certificates filed against the tool number.
What we are, and are not
We build the mould and the trial documentation. We are not a medical device manufacturer, so regulatory registration, sterilisation validation and clinical work stay with you. What we provide is a tool and a measurement record that your quality system can accept without a rework loop.
What we build to
| Typical part size | 0.1 g to 60 g, tight tolerance parts |
|---|---|
| Cavities | 4–32, cavity-numbered |
| Cavity steel | S136 ESR standard, H13 for PEEK / abrasive resins |
| Gate | Hot runner, individually controlled tips on small parts |
| Cooling | Symmetric, flow-verified cavity to cavity |
| Tolerance | ±0.01 mm on nominated features, confirmed against drawing |
| Tool life | 1,000,000+ shots with maintenance |
| Press tonnage | 50–350 t |
| Documentation | Steel certificates, dimensional report, trial process sheet, FAI / CPK on request |
| Lead time | 10–14 weeks from design freeze |
Send the drawing with the tolerances marked as critical. A ±0.01 mm callout on a feature that does not need it adds cost without adding value — and the conversation is easier before the steel is cut than after.
Questions from medical and precision buyers.
Can you hold ±0.01 mm on a moulded part?
On nominated features, yes — but the tolerance is a system result, not just a steel result. It depends on cavity machining, cooling symmetry, resin and process window. We agree which features carry the tight tolerance at quotation stage and report those dimensions per cavity.
Do you provide FAI and CPK documentation?
Yes, on request and quoted with the tool. We need the dimension list and the sample size your quality system expects, so the measurement plan matches the report format rather than being adapted afterwards.
Which steels do you use for PEEK and other high-temperature resins?
H13 or a comparable hot-work steel for the cavity, with appropriate heat treatment, plus heating provisions on the tool if the process needs them. Tell us the resin and melt temperature at quotation stage — it is the single biggest driver of tool steel choice.
Do you build cleanroom-compatible tooling?
The tool can be built with cleanroom-compatible materials, minimal exposed lubricant and a surface finish that supports cleaning. Running it in a cleanroom is the moulder's scope, but we design for it and can supply the surface and material documentation your audit asks for.
Send the drawing with critical tolerances marked.
You get steel grade, cavity plan, measurement method and documentation scope in writing — before any steel is ordered.