Product Overview:
The Silicone Gel-Based Empty Medicated Patch is a premium, skin-friendly platform designed for transdermal drug delivery, scar management, and cosmetic applications. Made from medical-grade silicone gel, it offers gentle adhesion, hypoallergenic properties, and residue-free removal, making it ideal for sensitive skin.
Material Specifications:
| Base | Medical silicone gel (50–300μm thickness) |
| Backing | Polyurethane film or non-woven fabric |
| Release Liner | Fluoropolymer-coated PET |
| Adhesion | Pressure-sensitive silicone, 0.5–3 N/25mm peel strength |
| Sizes | Custom from 2×2 cm to 15×20 cm |
Manufacturing Process
- Raw Material Testing: Viscosity, purity, and cure rate verification
- Mixing & Degassing: Vacuum mixing of silicone components
- Coating: Precision slot-die coating onto release liner
- Curing: Multi-zone thermal tunnels for controlled crosslinking
- Lamination: Backing applied with uniform pressure
- Die-Cutting: Servo-driven rotary cutting with optical registration
- Sterilization: Gamma irradiation (25–40 kGy) or EO
- Packaging: Foil pouches sealed in Class 100,000 cleanrooms
Manufacturer Advantages
- 20+ Years Expertise: Specialized in silicone medical devices since 2003
- In-House R&D: Dedicated chemists for custom gel formulations
- Advanced Facilities: ISO 13485 certified cleanrooms (Class 100,000/10,000)
- High Capacity: 30 million patches/month with strict QC
- Regulatory Support: FDA DMF, CE technical files, and global submissions
Certifications & Compliance
- ISO 13485:2016 (Medical Devices QMS)
- ISO 9001:2015 (Quality Management)
- CE Mark (MDR) – Class I medical device
- FDA Registered – Establishment and device listings
- USP Class VI & ISO 10993 (Biocompatibility: non-cytotoxic, non-irritant)
- REACH & RoHS Compliant
- Drug Master File (Type III) available for reference
Applications
- Transdermal pharmaceuticals (pain, hormones)
- Scar therapy sheets
- Wound care (secondary dressing)
- Cosmetic patches (anti-aging, hydration)
- Pediatric/geriatric sensitive skin care
Customization Options
- Gel hardness, thickness, and porosity
- Backing materials (breathable, transparent, printed)
- Sterile or non-sterile packaging
- Custom shapes and perforations
Quality Assurance:
Each batch tested for peel adhesion, tack, shear resistance, MVTR, and stability (accelerated aging). Certificate of Analysis provided.
Contact:
For orders or technical inquiries, contact our silicone medical division. Samples available within 7 days; lead time 30–40 days post-confirmation.
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