ISO 13485 CERTIFIED LSR INJECTION MOLDING
ISO 13485 CERTIFIED LSR INJECTION MOLDING
Flash-free LSR injection molding for medical valves, respiratory components, and precision electronic seals — manufactured in ISO Class 8 cleanrooms.
🔒 ISO 13485 certified · Class 100,000 cleanroom · Full FAIR & CPK data provided
Why LSR Injection Molding for Critical Applications
For medical devices and precision electronics, standard molding is not enough. LSR injection delivers capabilities that conventional silicone processing cannot match.
LSR injection molding delivers cycle times 40–60% faster than HCR compression molding, with dimensional repeatability of ±0.05mm maintained across million-shot production runs.
LSR Manufacturing Process
Every production stage is tightly controlled to ensure repeatable, medical-grade quality from first shot to final delivery.
01
Precise 1:1 A/B mixing with automated dosing control
02
Air evacuation before injection eliminates bubble entrapment
03
ISO Class 8 environment for medical-grade contamination control
04
Automated optical inspection — zero sampling, every part verified
05
Secondary curing removes volatiles. Double-packed in cleanroom
Zero sampling. Every part verified. Full FAIR report and CPK data included with every production batch.
Controlled Manufacturing Environment
Every stage of our LSR production process operates within a tightly controlled environment designed to meet medical-grade requirements.
01
ISO Class 8 Cleanroom Production
All LSR injection for medical and precision components is performed within our Class 100,000 (ISO Class 8) cleanrooms. Real-time particle counting and controlled air pressure differentials maintain contamination-free production conditions throughout every shift.
Dedicated cleanroom lines for medical-grade production — isolated from standard manufacturing areas.
02
Precision Closed-Loop Dosing
High-accuracy 1:1 closed-loop mixing systems ensure that every shot maintains consistent Shore A hardness, tensile strength, and dimensional properties. Material variance between batches is controlled to within ±1% of specified formulation ratios.
Consistent material physical properties verified on every production batch.
03
Specialized Post-Curing Process
All medical-grade LSR components undergo secondary oven curing to remove residual volatiles and stabilize final mechanical properties. Post-curing is performed in temperature-controlled ovens with documented time and temperature parameters for full batch traceability.
Post-curing parameters documented and included in every batch inspection report.
Technical Specifications
Full process parameters and material compliance data for every LSR production program.
| Parameter | Specification |
|---|---|
| Hardness Range | Shore A 5 – 80 (sub-5A available for dynamic medical seals) |
| Dimensional Tolerance | Down to ±0.05mm |
| Shot Weight Range | 0.05g – 500g per cavity |
| Cleanroom Grade | ISO Class 8 (Class 100,000) |
| Overmolding Substrates | PC / PBT / Metal / Glass / PEEK / PPSU |
| Material Compliance | FDA 21 CFR / LFGB / USP Class VI / ISO 10993 |
| Quality Documentation | FAIR report + CPK data per batch |
| T1 Sample Lead Time | 2–3 weeks from drawing approval |
Industries We Serve
Our LSR injection capabilities are optimized for applications where biocompatibility, dimensional consistency, and cleanroom production are non-negotiable requirements.
Also serving Beauty & Personal Care and Maternal & Infant Care applications.
Frequently Asked Questions for LSR Injection
A1：LSR injection molding delivers cycle times 40–60% faster than HCR compression molding. The closed-loop injection system significantly reduces contamination risks, offers superior detail reproduction for complex geometries, and maintains dimensional repeatability of ±0.05mm across million-shot production runs — critical for medical sealing interfaces where consistency is non-negotiable.
A2：Through precision-engineered cold runner systems and vacuum-assisted molds, combined with high-clamping force injection machines that precisely control injection point temperatures. This eliminates material leakage and ensures micro-valves and seals require zero manual trimming — eliminating human error and contamination risk from secondary processing.
A3：Yes. Our quality management system is ISO 13485 certified. All medical-grade LSR injection is performed within Class 100,000 (ISO Class 8) cleanrooms to meet stringent particulate and bioburden requirements. Certification documentation is available upon request.
A4：Yes. We provide a Full Inspection Report (FAIR) for every production run. For medical projects, we also provide CPK (Process Capability Index) data and material biocompatibility certifications covering ISO 10993 and USP Class VI requirements.
A5：No fixed MOQ. We support projects from single-cavity prototype tooling through to multi-cavity high-volume production. Project scope and tooling investment are evaluated during the DFM review based on your volume requirements and application.
ISO 13485 CERTIFIED · CLASS 100,000 CLEANROOM · FULL FAIR & CPK DATA
Ready to Eliminate Flash and Dimensional Inconsistency?
Share your CAD or STEP files with our engineering team. We provide a comprehensive DFM review covering gate feasibility, flash risk, and material compliance — delivered within 24 hours under strict Mutual NDA.