Description:
Our precision-engineered silicone one-way valves are manufactured using platinum-cured liquid silicone rubber (LSR) through advanced injection molding processes, ensuring 100% FDA-compliant and ISO 10993-certified performance for critical food, beverage, and medical applications. Designed with precision duckbill or diaphragm structures, these valves prevent backflow, maintain sterile barriers, and enable controlled unidirectional flow in systems requiring absolute hygiene. Rated for temperatures from -80°F to 437°F and resistant to steam sterilization (autoclave), chemicals, and aggressive media, they exceed FDA 21 CFR, USP Class VI, and EU 1935/2004 standards. As your specialized manufacturing partner, we provide end-to-end OEM solutions—including custom valve sizes (2–100mm), flow rates, durometer hardness (Shore A 20-80), and material certifications—backed by cleanroom production and high-volume capabilities. Ideal for aseptic packaging, respiratory devices, enteral feeding systems, and beverage dispensing.
Basic Information:
-
Place of Origin: Xiamen, China
-
Valve Type: Duckbill, diaphragm, umbrella, or ball check designs
-
Brand Name: OEM
-
MOQ: 5,000+ units (flexible for R&D projects)
-
Material: Platinum-cured LSR (food/medical grade)
-
Logo: Laser etching or molded branding (biocompatible inks)
-
Certifications: FDA 21 CFR, ISO 13485, USP Class VI, RoHS, REACH
-
Packaging: Double-bagged cleanroom packaging
-
OEM Services: Full customization support
-
Primary Use: Medical devices, food packaging, pharmaceutical systems, beverage dispensers
-
Sample Lead Time: 5–7 business days
-
Production Lead Time: 15–20 business days
Benefits:
-
Zero Contamination: Seamless, burr-free molding ensures integrity for sterile applications.
-
Precision Flow Control: Consistent cracking pressure (0.1–5 psi) and flow rates customized to application needs.
-
Durability: Withstands >1,000,000 cycles without fatigue or loss of sealing performance.
-
Easy Integration: Designed for snap-fit, threaded, or overmolding assembly.
-
Regulatory Ready: Full documentation support for FDA 510(k), CE marking, and other global standards.
-
Free Samples: Functional prototypes available for validation testing.
Quality Assurance:
Our quality process includes raw material validation (GC-MS testing for non-volatile residues), dimensional checks via vision systems (±0.01mm tolerance), and functional testing (flow rate validation, pressure decay testing per ASTM F2096). We utilize cleanroom production (ISO Class 7), FTIR spectroscopy for material verification, and 100% automated optical inspection for defect detection. All valves undergo batch-level traceability and comply with ISO 9001, ISO 13485, and cGMP standards.
Why Choose Us?
-
Expertise: 20+ years specializing in silicone valve manufacturing for critical applications.
-
Customization: Tailored valve designs, material formulations, and rapid prototyping with DFM support.
-
Advanced Manufacturing: Multi-cavity LSR injection molds with conformal cooling and automated degating.
-
Quality Commitment: Full validation support including biocompatibility testing and shelf-life studies.
Factory Showcase:
Our state-of-the-art facility features 16-cavity LSR injection molds with mirror-finish EDM surfaces, automated robotic demolding, and integrated vision inspection systems. Equipped with burst pressure testers (up to 100 psi), flow rate test stands, and environmental chambers for accelerated aging, we ensure precision performance for high-volume orders (500k+ units/month). Our ISO 13485-certified quality system includes full document control and lot traceability from raw material to finished valve.
