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SED-4-2YTG-Y
Consultar
SED-4-2YTG-Y
SED · SED-4-2YTG-Y · Destacado
SED-4-2YTG-Y — High-Speed Vial Liquid Filling and Stoppering Machine
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
High-speed (80-100 vpm) vial liquid filling and stoppering machine for 1-5ml vials in Grade A environment. Ceramic-pump filling with one servo per pump and stepper-driven inlet/outlet, synchronous-belt tracking conveyanc
Plazo de entrega
Consultar
Capacidad de producción
80–100 vials/min
Funcionamiento
Vials emerge from a depyrogenation tunnel and enter via a divider plate that rejects fallen/abnormal bottles. A star-wheel transfers them to a synchronous-belt tracking conveyor that moves vials at constant velocity. Filling needles track the rising liquid level (anti-foam, anti-splash) while ceramic pumps — one servo motor per pump for accuracy plus stepper-driven inlet/outlet — dispense the precise volume. A star wheel transfers filled vials to the dual-head stoppering station where stoppers from a SUS316L vibratory bowl are placed by a vacuum-driven reciprocating action; head height is adjustable for full or half stoppering. Stoppered vials exit through a star wheel onto a conveyor or a 500mm receiving dial. The whole filling area is enclosed in a Grade A C-RABS isolator with online detection of pressure/wind/particles/humidity/microbiology; opening the door auto-stops the machine.
Proceso de funcionamiento
1Vials emerge from a depyrogenation tunnel and enter via a divider plate that rejects fallen/abnormal bottles.
2A star-wheel transfers them to a synchronous-belt tracking conveyor that moves vials at constant velocity.
3Filling needles track the rising liquid level (anti-foam, anti-splash) while ceramic pumps — one servo motor per pump for accuracy plus stepper-driven inlet/outlet — dispense the precise volume.
4A star wheel transfers filled vials to the dual-head stoppering station where stoppers from a SUS316L vibratory bowl are placed by a vacuum-driven reciprocating action; head height is adjustable for full or half stoppering.
5Stoppered vials exit through a star wheel onto a conveyor or a 500mm receiving dial.
6The whole filling area is enclosed in a Grade A C-RABS isolator with online detection of pressure/wind/particles/humidity/microbiology; opening the door auto-stops the machine.
Especificaciones técnicas
Especificaciones de la variante: SED-4-2YTG-Y
Especificaciones
Modelo
SED-4-2YTG-Y
Capacidad de producción
80–100 vials/min
Tensión
380V 50Hz
Detalles de conformidad
Full validation document set: DQ, IQ, OQ, PQ, FAT, SAT, DQDR; 1-year warranty + lifetime maintenance; 36-hour service response; 48-hour spare parts dispatch.
Potencia
3.5 kW
Dimensiones
Longitud
3000 mm
Anchura
1160 mm
Altura
1900 mm
Peso
880 kg
Materiales
Materiales en contacto
316/316L stainless steel (parts in contact with the liquid); SUS316L (stopper vibratory bowl, stopper rail); pharma-grade imported silicone tubing with non-toxic certificate
Materiales del cuerpo
SS304 stainless steel base frame and table; SUS304 panels (Ra ≤ 0.4 μm at welded folds); FDA-validated high-density polyoxymethylene (POM) screws and bushings
Características principales
Ceramic-pump filling, one servo motor per pump (accuracy ≤1%)
Stepper-controlled inlet/outlet for filling stability
Synchronous-belt tracking conveyance — needles follow liquid level
Dual-head vacuum reciprocating stoppering with full/half-stopper switchable
Grade A C-RABS isolator on filling area with online glove leak detection
Online environmental detection: pressure differential, wind speed, particles, humidity, microbiology
Automatic sampling mode (auto + manual on individual pumps)
Aseptic transfer of stoppers via SUS316L vibratory bowl with pickup sensor (avoids missing stopper)
Horizontal stoppering layout per new GMP
φ900 in-feed turntable with auto reject for fallen vials
Torque limiters on main shaft and star wheels (auto-stop on jam, breakage <0.05%)
316L SS contact parts; FDA-grade POM screws and bushings
Stainless-steel base frame; touchscreen counter; 3-level password
Variable-frequency drive everywhere — quick star-wheel changeover
Imported pharma-grade silicone tubing with non-toxic certificate
Distributor surface roughness Ra ≤ 0.4 μm
Stoppering qualified rate ≥99%
No-bottle-no-stopper rate 100%
No-bottle-no-fill rate 100%
Filling accuracy ≤1%
Bottle breakage <0.05%
Noise ≤70 dB
Vacuum pump suction 50 m³/h
Compliant with 2015 Chinese Pharmacopoeia, 2010 GMP, JB/T 20098-2007, GB/T 5226.1-2002, EU sterilization standards, WHO, USP, IEC, CE
Comprehensive validation package (DQ/IQ/OQ/PQ/FAT/SAT/DQDR)
36-hour service response; 48-hour spare parts dispatch; 1-year warranty + lifetime maintenance
Aplicaciones
1-5ml antibiotic / liquid injectable vial filling and stoppering
Aseptic Grade A vial dosing
Sectores
Pharmaceutical injectables
Antibiotic / biopharmaceutical aseptic fill-finish
Marcas de componentes
PLC system (NX70 series)
Mitsubishi
Servo drives and motors
Mitsubishi / Delta
Inverter (22F-D2P5N103)
Mitsubishi
HMI (2711C-T10C)
Mitsubishi
Peristaltic pump (R520)
Spirax Sarco
Bearings (UCF/UCPH206/IR151916)
NSK
Coupling and torque limiter
Miki Pulley
Linear guide / linear bearing
Igus
Synchronous belt (672-8M-30)
BRECO-BELT
Proximity switch / mid-relay
Omron
Photoelectric switch / reflective fiber
Autonics
Switching power supply
Delta
Miniature circuit breaker / contactor / E-stop
Schneider
Vibratory feeder (450 stoppers/min)
Shanghai Jingmi
SED
Hable con SED Sales Team
Especialistas en equipos · contacto por WhatsApp
Consulte el horario y la disponibilidad del equipo
Conformidad
JB/T 20098-2007 antibiotic glass-vial liquid filling production line
GB/T 5226.1-2002 mechanical safety / electrical equipment
GB/T 4272-1992 thermal insulation
2015 Chinese Pharmacopoeia
2010 GMP and 2015 appendix
EU sterilization standard reference
WHO guidance reference
USP environmental and safety
ISO / IEC compliance
CE compliance
Limpieza y mantenimiento
Filling area operates under Grade A C-RABS isolator; stopper vibratory bowl and rail made of SUS316L; all product-contact silicone tubing imported with non-toxic certificate; distributor surface Ra ≤ 0.4 μm for cleanability.
Documentación
Ficha técnica (PDF)
Resumen del equipo, especificaciones y dimensiones · Documento original (inglés)
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Manual del operador
Instalación, funcionamiento y diagnóstico · Documento original (inglés)
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Ficha comparativa (Estándar y Económica)
Comparación de configuraciones · Documento original (inglés)
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Protocolos IQ / OQ / PQ
Documentación de validación para conformidad GMP · Documento original (inglés)
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Protocolos FAT / SAT
Pruebas de aceptación en fábrica y en sitio · Documento original (inglés)
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Planos CAD (STEP / IGES / DWG)
Planos de ingeniería para la instalación · Documento original (inglés)
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Certificados de calibración
Nivel sonoro, resistencia de tierra, rigidez dieléctrica y rugosidad · Documento original (inglés)
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DQ (cualificación del diseño)
Protocolo completo de cualificación del diseño · Documento original (inglés)
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Certificados de materiales
Composición del acero inoxidable 316L · Documento original (inglés)
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