ISO Class 7
Medical LSR molding and packaging performed in an ISO 14644-1:2015 Class 7 cleanroom.
Factory Capability Overview
A one-page summary of CYES SILICONE's manufacturing capability — equipment, processes, tooling, cleanroom, certifications and quality systems — for sourcing, engineering and quality review. Forward this page to your team or request a fuller audit package under NDA.
Company Profile
CYES SILICONE at a Glance
20+
Years — founded 2004
10,000 m²
Factory area
200+
Skilled staff
1000+
OEM / ODM projects
Serving 50+ export countries with a 98% on-time delivery rate. Figures are company-stated and available for verification during an on-site audit.
Molding Processes
Full Silicone Process Coverage
Full silicone-specialist coverage — from solid compression molding to LSR injection, extrusion and die cutting. Extrusion and die cutting are CYES differentiators rarely offered as in-house processes by competing silicone suppliers.
| Process | What it produces | Best for |
|---|---|---|
| Compression molding | Solid silicone parts in multi-cavity tools | Standard silicone goods, gaskets, kitchenware |
| LSR injection molding | Precision liquid silicone parts, cold-runner, 64-cavity | Medical, electronics, high-volume precision |
| 2-shot / multi-shot | Silicone bonded to thermoplastic in one cycle | Combined rigid + soft parts |
| Insert molding | Silicone over metal or plastic inserts | Threaded bosses, conductive cores |
| Overmolding / bonding | Silicone onto PC, ABS, PP, PA66, PBT, metal | Multi-material seals and grips |
| Extrusion | Continuous tubing, cord, profiles, edge seals | Constant cross-section parts |
| Die cutting | 2D gaskets, pads, interfaces from sheet | Flat sealing components |
| Assembly & welding | Component joining into complete functional products | Finished assemblies and kits |
Full detail on each process — molding, extrusion and overmolding & bonding. Engineering-plastic injection is available through qualified partners with CYES SILICONE managing DFM and quality.
Equipment List
Key Production & Inspection Equipment
| Equipment | Specification |
|---|---|
| LSR injection machines | YIZUMI UN120LSR / UN160LSR, ENGEL victory LSR 100, BOY LSR 55 E, Techen JCLS-400-15, KT-VS160-2S-3RT — with cold-runner, robotic demolding and post-cure |
| Compression presses | 20–500 ton clamping range |
| High-speed CNC milling | MAKINO, 24,000 RPM spindle — mold cavities to ±0.01 mm |
| Mirror / slow-wire EDM | Mitsubishi — mirror finish and ±0.005 mm fine features |
| CMM | HEXAGON Global S — mold cavity and electrode verification |
| CNC video measuring machine | 七海 SH SMV-3020 — ±0.003 mm, 300 × 200 mm range |
| Universal testing machine | CLD8, 5 kN — tensile, elongation, peel, tear |
| Environmental chamber | -40 °C to +150 °C — thermal and ageing testing |
Full equipment detail and calibration records — manufacturing engineering and testing & measuring equipment.
Cleanroom
Medical-Grade Production Environment
Third-Party Verified
Certified by third-party testing — certificate CR-2026-0714, tested October 2026.
Defined Scope
Class 7 applies to the medical LSR molding and packaging areas — not the entire factory.
Automotive-Grade Readiness
Built for High-Precision, High-Volume Seals & Components
±0.01 mm Mold Accuracy
MAKINO 24,000 RPM CNC milling and Mitsubishi mirror EDM hold mold cavities to ±0.01 mm, with HEXAGON Global S CMM verification — the precision required for automotive seals, gaskets and sensors.
ISO Class 7 Cleanroom
ISO 14644-1:2015 Class 7 cleanroom for medical LSR molding and packaging, third-party verified (cert. CR-2026-0714). A controlled environment ready for contamination-sensitive components.
Documented Cpk Evidence
Real process-capability data, not claims — medical LSR diaphragm Cpk 1.24, FVMQ seal Cp 1.39 / Cpk 1.32 (n = 50). Demonstrated ability to hold tight tolerances in sustained production.
Automotive-grade QC practices aligned with IATF 16949 expectations (CYES SILICONE does not claim IATF 16949 certification). Process-capability evidence — Cpk & process capability and testing & measuring equipment.
Certifications & Compliance
Quality Systems & Material Compliance
| Category | Standards |
|---|---|
| Management systems | ISO 9001 · ISO 14001 · ISO 45001 · ISO 13485 |
| Social compliance | SEDEX SMETA · BSCI |
| Material compliance | FDA 21 CFR · LFGB · RoHS · REACH · PFAS Non-Detect (EPA 537.1 / ISO 21675) |
| Third-party testing | CTI reports covering 13 standards |
Identifiable certificates and full reports are released under NDA for qualified projects. See quality documents for the document library.
Quality Systems
Documented Quality & Process Capability
FAI & PPAP Level 3
18-item PPAP Level 3 checklist, FAI reports and Gage R&R available per project.
Process Capability
Documented Cpk studies — e.g. medical LSR diaphragm Cpk 1.24, FVMQ seal Cp 1.39 / Cpk 1.32 (n = 50).
Full Traceability
Every lot linked from raw material and mold to machine, operator and shipment.
Quality evidence — engineering evidence and PPAP & quality docs.
Request the Full Capability Package
For a PDF version of this overview, or the complete audit package (certificates, cleanroom report, Cpk datasets, equipment list), request it through the quote form under NDA.
Request Capability Package