LSR Medical Grade Gasket
Medical-grade LSR gasket, platinum-cured, biocompatible, -50°C to 230°C
Description
Our LSR Medical Grade Gasket is manufactured in a 100,000-class cleanroom using platinum-cured liquid silicone rubber (LSR). It offers excellent biocompatibility, making it ideal for medical devices, pharmaceutical equipment, and food processing applications. The gasket provides superior sealing performance with temperatures ranging from -50°C to 230°C. Custom sizes and geometries are available with fast prototyping services.
Specifications
| Material | LSR (Liquid Silicone Rubber) |
| Hardness | 50±5 |
| Operating Temperature | -50°C to 230°C |
| Color | Transparent / Custom |
| Certifications | ISO 13485 |
| MOQ | 1000 |
| Lead Time | 15 days (after approval) |
| Customization | Drawing or sample based, full dimensional report provided |
Engineering & Quality Documentation
📋 Technical Standards
- ISO 10993 biocompatibility test reports available per material lot
- USP Class VI and FDA 21 CFR 177.2600 compliant grades
- ISO 13485-aligned quality management and DHR per lot
- RoHS / REACH SVHC-free declaration on request
🏭 Manufacturing Process
Platinum-cured LSR injection molded in a class-100,000 cleanroom on vertical presses with cold-deck flashless tooling.
- Closed material dosing — no operator contact or particulate ingress
- Controlled post-cure stabilizes biocompatibility-critical volatiles
- Cleanroom molding, inspection and double-bag packaging in one cell
🔍 Quality Inspection
- ▸ 100% visual inspection before packing (flash, short-shot, contamination)
- ▸ Dimensional verification against approved drawing; FAI report on first shipment
- ▸ Hardness per ASTM D2240 (Shore A) on every batch
- ▸ Lot traceability: material batch and cure records logged per carton
- ▸ Biocompatibility verification per ISO 10993 on material grade changes
- ▸ Tensile and elongation per ASTM D412 to confirm cure state
🛡️ After-sales & Warranty
12-month warranty against material and workmanship defects. Full DHR, CoC and FAI ship with every order; confirmed non-conformances are replaced free with expedited re-shipment at our cost.
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