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SED-4-2YTG-Y
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SED-4-2YTG-Y
SED · SED-4-2YTG-Y · Em destaque
SED-4-2YTG-Y — High-Speed Vial Liquid Filling and Stoppering Machine
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. 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
Prazo de entrega
Consultar
Capacidade de produção
80–100 vials/min
Como funciona
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.
Processo de funcionamento
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.
Especificações técnicas
Especificações da variante: SED-4-2YTG-Y
Especificações
Modelo
SED-4-2YTG-Y
Capacidade de produção
80–100 vials/min
Tensão
380V 50Hz
Detalhes de conformidade
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.
Potência
3.5 kW
Dimensões
Comprimento
3000 mm
Largura
1160 mm
Altura
1900 mm
Peso
880 kg
Materiais
Materiais de contato
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
Materiais do corpo
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 principais
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
Aplicações
1-5ml antibiotic / liquid injectable vial filling and stoppering
Aseptic Grade A vial dosing
Setores
Pharmaceutical injectables
Antibiotic / biopharmaceutical aseptic fill-finish
Marcas dos 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
Fale com SED Sales Team
Especialistas em equipamentos · contato pelo WhatsApp
Consulte o horário e a disponibilidade da equipe
Conformidade
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
Limpeza e manutenção
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.
Documentação
Ficha técnica (PDF)
Visão geral do equipamento, especificações e dimensões · Documento original (inglês)
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Manual do operador
Instalação, operação e diagnóstico · Documento original (inglês)
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Folha comparativa (Padrão e Econômica)
Comparação das configurações · Documento original (inglês)
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Protocolos IQ / OQ / PQ
Documentação de validação para conformidade GMP · Documento original (inglês)
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Protocolos FAT / SAT
Testes de aceitação na fábrica e no local · Documento original (inglês)
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Desenhos CAD (STEP / IGES / DWG)
Desenhos de engenharia para a instalação · Documento original (inglês)
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Certificados de calibração
Nível sonoro, resistência de terra, rigidez dielétrica e rugosidade · Documento original (inglês)
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DQ (qualificação do projeto)
Protocolo completo de qualificação do projeto · Documento original (inglês)
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Certificados de materiais
Composição do aço inoxidável 316L · Documento original (inglês)
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