MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Read moreClean Room Injection Moulding
Contamination control as a production condition, not a promise
Sanpin Medical · since 2019
Overview
Moulding carried out inside a controlled environment that holds down dust, airborne microbes and chemical vapour. The clean room exists because medical and electronics parts fail for reasons that never show up on a dimensional report, and those failures are found by the end user rather than by inspection.
Problems
What This Fixes
- Particulate picked up on the shop floor between moulding and packing
- Suppliers who mould in open workshops and only bag the parts afterwards
- Audit findings on environmental control during a customer or notified-body visit
- Electronics assemblies contaminated before they are ever populated
Benefits
What You Get
- Moulding, not just packing, happens inside the controlled environment
- The facility is built to sit inside an ISO 13485 quality system, so the records exist
- Suits both medical devices and the electronics work that has the same cleanliness demands
- Sits in the same group as the tooling shop, so a cavity can be corrected without a new vendor
Who For
Suited To
- Medical device companies with single-use or fluid-path components
- Diagnostics and laboratory consumable brands
- Electronics OEMs whose assemblies cannot tolerate particulate
Scenarios
Typical Jobs
- Single-use fluid-path parts that go straight into a sterile barrier pack
- Optical or sensor housings where a particle becomes a visual defect
- Lab consumables moulded and packed without an intermediate handling step
Technical
How It Runs
- Controlled environment maintained through the moulding step itself
- Clean room operations run under the ISO 13485:2016 system held by Sanpin Medical
- Quality management overseen by our French partner to European and American expectations
- Documentation retained to support your regulatory submission
At A Glance
Specification
Everything below is published because it is what an engineer checks before sending a drawing. Anything not listed is confirmed in the quotation rather than guessed at here.
| Capability | Clean Room Injection Moulding |
|---|---|
| Group company | Sanpin Medical, established 2019 |
| Category | Plastic Injection Moulding |
| Location | Shenzhen, Guangdong, China |
| Certification | ISO 9001:2015 / ISO 13485:2016 |
| Post-treatment | Plating, Anodizing, Painting, UV printing, Screen printing |
| Response time | Engineer replies within 24 hours |
Order Process
How This Job Would Run
The same eight stages apply whether the order is a single tool or a production programme.
Request A Quote
Send the part drawing or 3D file by email. An engineer comes back within 24 hours with a consultation, not an auto-reply.
DFM Report
Before any steel is cut we return a design-for-manufacture report that flags flaws and errors in the design, so they are fixed on paper.
Mould Design & Moldflow
A predictive model analyses how the molten material behaves inside the cavity. Flow analysis settles gating and cooling before tooling.
Mould Tooling Production
Tooling is cut from the steel grade chosen for the application, not from whatever is on the rack.
T1 Sample Inspection
First-trial samples go out for your inspection and review. Errors are identified on T1, before mass production is committed.
Low Volume Production
A low-volume run follows the trial phase, so precision is proven on real machines under expert surveillance before the ramp.
Strict Inspection
Parts are inspected against international tolerance standards and against the specification you supplied.
Delivery
Parts are packaged to survive the journey and released through our logistics partners on a scheduled delivery.
Questions
About Clean Room Injection Moulding
Is the clean room used for moulding or only for assembly?
For moulding. The controlled environment covers the moulding step, which is the point at which contamination would otherwise be trapped in the part.
Which certifications cover this area?
Sanpin Medical holds ISO 9001:2015 and ISO 13485:2016. The clean room operates inside that system.
Can you support our FDA or CE submission?
Our French partner manages the quality system and assists clients in obtaining FDA and CE certification. Ask for the specific documentation you need and we will confirm what we hold.
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Read moreGet This Quoted
Attach the drawing or the 3D file and tell us the annual quantity. An engineer replies within 24 hours with a consultation.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.