α β Split Butterfly Valve

• Customization: Available
• Media: Water
• Pressure: Low Pressure
• Temperature: Low Temperature
• Connection: Clamp
• Material: Stainless Steel
• Size: 1/2"-1"
• Body Material: SS316L
• Connection End: Welded, Clamped,
• Mode: Manual Pneumatic
• Transport Package: 200*200
• Specification: 1/2"-1"
• Trademark: kinglai
• Origin: China
• HS Code: 73072900
• Production Capacity: 500000PCS
• Package Size: 50.00cm * 50.00cm * 50.00cm
• Package Gross Weight: 20.000kg

Product Description

I. Core Highlights: Redefining Powder Containment Standards

1. Split Design for Efficiency & Safety Enhancement

• Modular Architecture:
  • Main valve permanently mounted on equipment, secondary valve compatible with mobile containers (tote bins, isolators), enabling rapid docking/separation (<30s) to minimize cross-contamination risks.
• Interlock Mechanism:
  • 90° rotation handle triggers mechanical interlock - valve remains locked until fully engaged, preventing human error leaks (compliant with OEB5).

2. Superior Sealing Performance Beyond Industry Standards

• Triple Redundancy Protection:
  • Metallic hard seal (316L SS) resists high-pressure impacts;
  • FFKM rubber dynamic seal withstands -20ºC~200ºC;
  • Static secondary seal compensates for micro-deformations (leakage <10μg/m³, ISPE certified).
• Sterilization Compatibility:
  • Survives 121ºC steam sterilization for 30min without deformation, supports VHP gas sterilization for aseptic production.

3. Materials & Craftsmanship: Full Regulatory Compliance

• Pharmaceutical-grade Surface Finish:
  • Contact side Ra≤0.8μm mirror polish, non-contact side Ra≤1.6μm to reduce residues;
  • FDA-certified FFKM seals (SGS verified) with no extractables (USP Class VI compliant).

 

II. Technical Advantages: Tailored for Pharmaceutical Processes

Wide Process Adaptability

• Pressure/Vacuum Compatibility:
  • 0~1Bar range with optional vacuum sealing components;
  • Integrated pressure monitoring ports, sapphire glass view windows (optional), CIP/SIP multi-port spray balls.

Intelligent Maintenance Management

• Predictive Maintenance System:
  • Pressure sensors warn of seal wear (validated for >5,000 cycles);
  • Quick-change toolkits enable <15min seal replacement without specialized tools.

Full Validation Support

• Modular DQ/IQ/OQ Documentation:
  • GAMP 5-compliant software package with electronic signatures and audit trails, reducing FDA/NMPA certification time by 6+ months.

 

III. Key Application Scenarios in Pharma

Application Scenario	Solution
High-potency API Transfer	αβ valve + αβ butterfly combo for RABS/isolator containment	API	αβ+αβRABS/
Aseptic Formulation	Seamless integration with isolators/freezers, supports SIP 121ºC/30min		,,
Hazardous Waste Handling	Sealed collection to prevent cross-contamination (EHS compliant)		,EHS
Multi-product Switching	Quick-change design (<30min) for small-batch/multi-product lines		,

 

IV. Quality Commitment & Service Network

1. Rigorous Quality Testing

• 24/7 Validation Tests:
  • Static water tightness (24h leakage <1ppm), dynamic pressure cycling (100k cycles), thermal shock (-40ºC~150ºC).
• Material Traceability:
  • 316L SS batch MTRs provided, seal lot numbers laser-marked for traceability.

2. Global Technical Support

• Localized Services:
  • Technical centers in China/USA/Europe, 72hr emergency spare parts response.
• Digital Monitoring Platform:
  • Remote diagnostics track valve status, predict failures, and push maintenance alerts.

3. Customer Value Validation

• Top 50 Pharma Partners:
  • Used by Pfizer, Roche, Hengrui in  vaccines/oncology drugs projects.
• Cost Optimization Case:
  • European customer reduced CIP/SIP energy by 30%, saving €200k annually.