Customize High Precision Silicone Medical Valves for Sealing Medical Appliances Manufacturers

Overview:

Our Customized High-Precision Silicone Medical Valves for Sealing Medical Appliances are engineered to deliver reliable, leak-proof performance in critical healthcare applications. Manufactured from 100% medical-grade silicone (per ISO 10993), each valve is produced using precision liquid silicone rubber (LSR) injection molding to achieve exacting dimensional tolerances and consistent sealing properties. As specialized OEM manufacturers, we offer comprehensive customization—including custom geometries, durometer (20–80 Shore A), and integrated color coding—to meet stringent requirements for infusion pumps, respiratory devices, dialysis machines, and other sterile medical equipment. Every valve is produced under controlled cleanroom conditions (ISO 7), ensuring contamination-free components that comply with FDA, CE, and ISO 13485 standards.

Characteristics:

Material & Finish Options:

1. Medical-Grade Silicone Selection
   • Utilizes platinum-cured LSR compounds that meet ISO 10993 biocompatibility standards, ensuring no cytotoxicity, skin irritation, or sensitization.
2. Color Coding & Identification
   • Incorporates FDA-approved medical-grade pigments for custom color coding (e.g., blue for respiratory valves, green for infusion valves), facilitating easy component identification in assembly and maintenance.
3. Surface Treatment
   • Plasma or Corona Treatment: Enhances surface energy for superior bonding with adhesives or overmolded rigid plastics (e.g., LSR-to-PP bonding).
   • Matte or Gloss Finish: Customizable mold surface polish levels (SPI A-1 to D-1) to achieve non-reflective matte or high-gloss finishes, minimizing particulate retention in sensitive medical environments.
4. Embedded Features
   • Metal or RFID Tag Insert Molding: Optional integration of thin metal shims or RFID tags during molding for device traceability and performance monitoring.
   • Multi-Layer Overmolding: Combines soft sealing surfaces (low durometer) with higher durometer support rings to optimize peak pressure resistance.

Quality Assurance:

Our rigorous QA protocol aligns with ISO 13485 and GMP regulations, ensuring each medical valve meets or exceeds industry benchmarks:

• Material Certification & Traceability: All silicone lots are accompanied by Certificate of Analysis (CoA) confirming compliance with ISO 10993 for biocompatibility (cytotoxicity, sensitization, irritation).
• Dimensional Inspection: Coordinate Measuring Machines (CMM) verify critical dimensions to ±0.01 mm tolerance.
• Hardness Verification: Shore A durometer testing on a digital Shore meter confirms hardness within ±2 units of specified value.
• Compression Set Testing: Conducted per ASTM D395 to ensure < 10% compression set after 22 hours at 70 °C.
• Tensile & Tear Strength Testing: Using a universal testing machine (UTM), we confirm tensile strength ≥ 6 MPa and tear strength ≥ 20 kN/m.
• Leak & Back-Pressure Testing: Custom fixture rigs simulate fluid or air pressures (up to 2 bar) to verify zero leakage and proper valve opening/closing behavior.
• Sterilization Validation: Batch samples undergo autoclave, gamma, or EtO sterilization cycles, followed by post-sterilization testing (dimensional recheck, hardness, and functional performance).
• Particulate & Extractables Testing: Conducted by third-party labs to confirm < 10 µg/cm² nonvolatile residue and absence of heavy metals.
• Automated Visual Inspection: High-resolution vision systems detect surface defects (bubbles, inclusions, flash) at 10 µm sensitivity.

Every valve must pass 100% in-house inspection before being packaged in sterile, medical-grade pouches and shipped under controlled humidity and temperature conditions.

Factory Show:

Our ISO 7 Cleanroom–Certified Manufacturing Facility is purpose-built to support high-precision medical molding and assembly:

• Precision LSR Injection Molding Machines (15–100 ton capacity) equipped with multi-shot overmolding capabilities, ensuring ±0.02 mm repeatability in valve geometries.
• Multi-Cavity Medical-Grade Tooling fabricated on 5-axis CNC machining centers and finished via mirror EDM to achieve ultra-smooth cavity surfaces (SPI A-1 finish), minimizing particulate generation.
• Class 7 & Class 8 Clean Rooms for molding and post-molding operations, complete with HEPA filtration and positive air pressure to maintain < 10,000 and < 100,000 particles ≥ 0.5 µm per ft³.
• Automated Automated AutoDryers & Hot-Air Ovens for controlled post-cure cycles, ensuring complete crosslinking and optimal mechanical properties.
• 3D Optical Projectors, High-Precision CMMs, and Surface Profilometers under ISO 7 conditions for contamination-free dimensional verification.
• Environmental Test Chambers with temperature and humidity control to conduct accelerated aging, compression set, and environmental stress tests.
• Sterile Assembly Bays with Laminar Flow Hoods (Class 1000) for final valve assembly and packaging, preventing microbial contamination.
• Automated Material Handling & RFID Tracking to maintain full lot traceability and real-time inventory management, ensuring every component matches its production data and quality records.

Backed by ISO 9001 and ISO 13485 certifications, our facility integrates lean manufacturing principles, real-time process monitoring, and a dedicated QA team to deliver high-precision silicone medical valves that meet the most demanding performance, safety, and regulatory requirements of medical device manufacturers.