Custom Medical Silicone Rubber Umbrella Check Valve Mushroom Valves Injection Molding Supplier

Overzicht

Our Custom Medical Silicone Rubber Umbrella Check Valve (Mushroom Valve) is a precision-engineered fluid control component manufactured for critical applications in diagnostic, therapeutic, and life-science devices. Produced in a certified cleanroom environment using high-purity, biocompatible Liquid Silicone Rubber (LSR) and precision injection molding, this valve ensures reliable, leak-proof unidirectional flow to prevent backflow and contamination. Designed for integration into IV sets, respiratory circuits, lab-on-a-chip devices, and drug delivery systems, our OEM service provides complete customization—from material validation and design optimization to sterile packaging—ensuring full compliance with ISO 13485 and global medical regulatory requirements.

Basisinformatie

Voordelen van Onze Producten

• Certified Biocompatibility & Safety: Manufactured from clinically validated LSR with ultra-low levels of extractables and leachables, ensuring safety for direct patient contact and fluid pathways.

• Precision Fluid Control & Reliable Sealing: The umbrella/mushroom design provides a consistent, low-dead-volume seal essential for accurate fluid handling, preventing backflow contamination in sensitive medical circuits.

• Cleanroom Manufacturing Integrity: Produced in a controlled ISO Class 8 (or better) cleanroom environment, guaranteeing particulate control and microbiological standards required for invasive and critical care devices.

• Validated for Sterilization & Chemical Resistance: Engineered to maintain dimensional stability, elasticity, and performance integrity through repeated cycles of standard medical sterilization and exposure to aggressive fluids.

• Full Design & Compliance Support: We offer end-to-end collaboration to customize all functional parameters—including flow rate, pressure differential, and connection interfaces—while providing full documentation for your regulatory submission.

Kwaliteitsborging

Our quality assurance is built upon our ISO 13485 certified quality management system, ensuring complete traceability and control for medical device manufacturing. We enforce strict material qualification with full Certificates of Analysis (CoA) and batch traceability. Every production lot undergoes 100% automated optical inspection (AOI) for critical dimensions and defects, along with statistical functional testing for crack/re-seal pressure and leak integrity. Our processes include rigorous cleanroom environmental monitoring, and we provide comprehensive validation support, including sterilization validation data packages, biocompatibility reports, and full Device History Records (DHR) for lot release.

Why Partner with Us for Your Manufacturing Needs?

1. Dedicated Medical Device Expertise: We specialize in the design and manufacturing of high-tolerance silicone components for the medical industry, with a deep understanding of regulatory pathways and design controls.

2. End-to-End Regulated OEM Solution: We provide a seamless, single-source service from concept and DFM through to validation, scalable production, and sterile packaging, all within a certified QMS framework.

3. Certified Cleanroom Production & Scalability: Our dedicated cleanroom LSR injection molding lines ensure product purity and are capable of scaling efficiently from R&D prototyping to high-volume commercial supply.

4. Commitment to Compliance & Documentation: We prioritize regulatory compliance, providing the extensive documentation, material certifications, and validation support necessary for your successful regulatory approval and audit readiness.

Fabriek Tentoonstelling

Our manufacturing facility features a dedicated, certified ISO Class 8 cleanroom complex housing automated LSR injection molding machines with closed material handling systems to ensure contamination-free production. The supporting toolroom is equipped with high-precision CNC machining centers and mirror EDM for crafting molds that meet exacting medical tolerances. Within the cleanroom, post-molding processes include dedicated laser vision measurement systems for inspection and automated functional test stations. This vertically integrated, controlled environment is managed under our ISO 13485 system, ensuring we deliver medical-grade valves of consistent quality, reliability, and traceability for the most demanding global healthcare applications.