Precision Sterile 360-Degree Dispensing Valve for Single-Use Medical Kits and

Product Specification

Precision Sterile 360-Degree Dispensing Valve for Single-Use Medical Kits and Saline Applications with Luer Lock Connection

Product Description:

Engineered for the highest standards of safety and precision, our sterile 360-Degree Dispensing Valve is a critical component for single-use medical devices, irrigation kits, and diagnostic equipment. This valve is manufactured in a certified cleanroom environment and is available pre-sterilized by gamma irradiation, ready for integration into your medical-grade products. Its omni-directional operation allows healthcare professionals to dispense saline, antiseptics, or other sterile fluids from any angle during procedures, enhancing ergonomics and procedural efficiency in the operating room or clinic. The valve features a standard Luer Lock connection, ensuring a secure, leak-proof attachment to syringes, tubing, and collection containers. The precision one-way valve mechanism guarantees a consistent, controlled flow rate, preventing accidental discharge and maintaining a sterile field. Constructed from biocompatible, latex-free materials, this liquid dispenser meets stringent ISO and USP Class VI standards. By incorporating this valve, you ensure your medical device delivers the reliability, safety, and performance demanded in critical healthcare settings.

Bullet Points:

• Supplied pre-sterilized and ready-to-use for integration into single-use medical kits.

• Standard Luer Lock connection ensures secure, universal compatibility with medical devices.

• Precision flow control allows for consistent, measured dispensing of sterile fluids.

• Manufactured from ISO 10993 certified, biocompatible, and latex-free materials.

• Omni-directional function provides ergonomic flexibility during complex medical procedures.

Specific Application Scenario
During a wound cleaning procedure, a nurse needs to irrigate the area with a sterile saline solution. Using a bag fitted with this valve and a Luer Lock syringe, they can draw the saline by pulling back the plunger and then dispense it from an optimal angle to flush the wound thoroughly, all while maintaining a completely sterile, closed system.

Factory Production Floor
Production occurs in an ISO Class 7 cleanroom with stringent environmental controls. All personnel wear full cleanroom apparel. The assembly process is automated where possible to minimize human intervention. Every batch undergoes 100% integrity testing, and the final product is released only after passing stringent biological and particulate matter testing to meet medical device protocols.

Packing and Transportation
Each valve is packed in a primary, sterile barrier pouch (Tyvek® or medical-grade foil) with sterility indicators. These pouches are then packed in sealed, labeled cartons that are palletized and shipped with temperature and humidity monitoring where required, ensuring the chain of custody and sterility is maintained.

FAQ

1. What sterility assurance level (SAL) does this dispensing valve meet?

   • The valve is terminally sterilized and validated to meet a Sterility Assurance Level (SAL) of 10^-6, meaning there is less than a one-in-a-million chance of a single viable microorganism being present.

2. Is this omni-directional liquid dispenser compatible with all common diagnostic reagents and solvents?

   • It is compatible with a wide range, including saline, water, and alcohol-based solutions. For specific aggressive chemical agents used in laboratories, we recommend a compatibility review with our technical team.

3. Can the Luer Lock connection be specified as Luer Slip?

   • Yes, we offer customization for the connection type, including Luer Lock, Luer Slip, or other proprietary interfaces to meet your specific device design requirements.

4. How does the one-way valve prevent backflow and maintain sterility?

   • The valve's internal diaphragm creates a positive seal that only opens under forward pressure, effectively preventing any backflow of potentially contaminated fluids into the sterile container or system.

5. What documentation is provided for quality assurance and regulatory submissions?

   • We provide a full Device Master Record (DMR) package, including a Certificate of Conformance, material certifications, sterilization certificates, and full traceability for every manufacturing lot.