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Certified Sanitary 360-Degree Dispensing Valve for Pharma, Food, and Cosmetic Filling Lines with CIP/SIP Compatibility
Product Description:
Meet stringent hygienic standards with our Certified Sanitary 360-Degree Dispensing Valve, engineered for GMP-regulated environments requiring uncompromised cleanliness. This hygienic rotary dispenser features FDA/USP Class VI compliant materials (EPDM, PTFE, 316L electropolished stainless steel) and full 3-A Sanitary Standards certification. The clean-in-place rotary valve enables 360° maneuverability during precision filling of vaccines, syringes, food pastes, or cosmetic creams while supporting automated SIP (Steam-In-Place) cycles up to 140°C. Zero dead-leg design and mirror-finished surfaces (Ra ≤0.4μm) prevent bacterial harborage, with quick-disassembly clamps allowing <5-minute changeovers between batches. As a multi-axis filling head, it delivers ±1% volumetric accuracy for doses from 0.1ml to 500ml at production speeds up to 300 units/minute. Unique benefits include integrated pressure sensors for real-time monitoring and optional aseptic barrier integration. Ideal for blow-fill-seal machines, sterile syringe assembly, or nutraceutical encapsulation, this pharma-grade swivel valve reduces contamination risks, validates cleaning protocols, and meets FDA 21 CFR Part 11 data integrity requirements through digital traceability.
Bullet Points:
Seamless 360-Degree Dispensing Valve with 3-A & EHEDG certifications
Clean-in-place rotary valve withstands 100+ SIP cycles without degradation
Electropolished fluid path (Ra 0.38μm) eliminates microbial adhesion
Digital batch reporting via integrated IoT sensors (optional)
Supports filling accuracy of ±0.5% at 0.1-500ml volumes
Specific Application Scenario:
Filling antibiotic vials in ISO Class 5 cleanroom using RABS system, requiring sterile angle adjustments between filling needles.
Component | Part No. | Part Description |
Mounting cup | 1-F2 | Both sides with clear lacquered tinplate ,with down dimples |
Outer gasket | 1-G1 | Buna |
Inner gasket | 1-B4 | Neoprene |
Stem | 1-A7 | Orange color, double orifice 2X diameter 0.51mm |
Spring | 1-C1 | Stainless steel |
Housing | 1-D1 | all direction valves housing tail orifice: diameter 2.0mm with stainless steel ball white |
FAQ:
Q: What documentation supports the pharma-grade swivel valve’s compliance?
A: Supplied with 3.1 material certificates, USP <87>/<88> testing reports, and full DQ/IQ/OQ validation packets.
Q: Can the multi-axis filling head integrate with isolator technology?
A: Yes – designed for glove-port mounting with aseptic transfer compatibility.
Q: Maximum temperature for SIP sterilization?
A: 140°C for 30 minutes; 50+ validated cycles guaranteed.
Q: Are custom tri-clamp sizes available?
A: Standard 1.5"-4" tri-clamps; custom sizes (DN15-DN100) with 4-week lead time.
Q: Data logging capabilities?
A: Optional MODBUS/OPC-UA module records pressure, temperature, and rotation data per batch.