Traceable
Report numbers carry a certificate or study reference (e.g. CR-2026-0714, LSR-MED-007) so they can be checked, not just quoted.
Engineering Evidence & Verification
Claims are easy; evidence is harder to fake. This page summarizes the verifiable engineering records we maintain — cleanroom test reports, SPC and Cpk data, equipment, dimensional inspection and material compliance — so you can audit what we say before you commit.
Our Evidence Principle
We Report What We Measured, Not What Sounds Best
Every number on this site is tied to a real record. Where a result is below a common benchmark, we say so rather than hiding it — because a supplier who is honest about one Cpk reading is more likely to be honest about everything else.
Bounded
We state exactly what a claim covers. The cleanroom is one classified area, not the whole plant. A Cpk reading is one study, not a blanket promise.
Releasable
Documents are released for genuine sourcing and audit. Sensitive client data and raw measurement files stay confidential and move only under NDA.
Cleanroom
ISO Class 7 — Verified, Not Assumed
Our medical-grade molding environment is classified to ISO 14644-1:2015 Class 7 and verified by an independent third-party cleanroom testing laboratory.
| Item | Detail |
|---|---|
| Classification | ISO Class 7 (ISO 14644-1:2015) |
| Certificate | CR-2026-0714 — tested October 2026 |
| Coverage | LSR medical molding and packing area only — this is one designated zone, not the entire facility |
| Verification | Independent third-party cleanroom testing laboratory |
| Availability | Full report on request |
SPC & Capability
Process Capability Data
We run statistical process control and capability studies on critical dimensions and properties, and report the measured result honestly.
| Study | Part | Measured result | Note |
|---|---|---|---|
| LSR-MED-007 | Medical LSR diaphragm sealing component | Cpk 1.24 | Measured result — we do not present this as better than the common 1.33 target |
See how we structure capability and measurement in quality inspection and PPAP & quality documentation.
Equipment & Dimensional
Equipment List and Dimensional Inspection
Our equipment list covers molding machines, tooling, inspection and post-processing. Dimensional reports are generated from first-article and in-process measurement on calibrated instruments.
Equipment List
Molding machines, tooling, inspection and post-processing equipment — released on request so you can verify the capability behind a quote.
Dimensional Reports
First-article inspection (FAI) and dimensional reports against your drawing tolerances, with measurement traceability. See mold making for tooling accuracy.
Where a program needs CMM-level measurement, we arrange it before quoting — we state capability as it is, not as we wish it were.
Material Compliance
Third-Party Material Reports
Food-contact and medical-grade materials are tested by CTI — Centre Testing International Group Co., Ltd. (Shenzhen, China) — against the standards your market requires.
FDA
21 CFR food-contact testing for food-grade silicone.
LFGB
German food and commodity compliance for EU markets.
RoHS
Restriction of hazardous substances for electronics.
REACH
Chemical safety registration for the EU market.
The exact report depends on your product and target market — we confirm the applicable documentation during quoting. Full reports are available on request under NDA.
Request the Evidence
Get the Documentation Behind the Claim
All of the above can be packaged into a single Engineering Capability Pack for qualified projects — including the factory and equipment list, ISO 9001 certificate, cleanroom report, material reports, mold precision statement and IQC/IPQC/OQC flow.
Audit Us Before You Commit
Send your drawing and compliance needs — we'll confirm the evidence we can provide for your market, and quote the project.
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