Início / Equipamentos / Linha de isoladores de envase asséptico de frascos / Vial Aseptic Filling Isolator Production Line
SED-50XWGX-A
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SED-50XWGX-A — Vial Aseptic Filling Isolator Production Line
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
Small-batch R&D and pilot-scale vial aseptic filling line with isolator. Integrated system combining aseptic isolator, in-line liquid filling machine, stoppering machine, and multifunctional capping/sealing machine. Perf
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Prazo de entrega
Consultar
Capacidade de produção
20–50 frascos/min
Como funciona
After sterilization, vials enter the star-wheel conveying system and are transferred to the conveyor by small star wheels. Vials move at constant speed on a synchronous belt into the filling station, where the filling needle rack doses the liquid into each vial. Filled vials pass through the volume inspection/sampling station; acceptable vials proceed to the stoppering station for full or half stoppering. Stoppered vials then pass to the crimping machine for aluminum-cap crimp-sealing. The entire process is completed in a Grade A environment; opening an isolation door triggers automatic shutdown.
Processo de funcionamento
1After sterilization, vials enter the star-wheel conveying system and are transferred to the conveyor by small star wheels.
2Vials move at constant speed on a synchronous belt into the filling station, where the filling needle rack doses the liquid into each vial.
3Filled vials pass through the volume inspection/sampling station; acceptable vials proceed to the stoppering station for full or half stoppering.
4Stoppered vials then pass to the crimping machine for aluminum-cap crimp-sealing.
5The entire process is completed in a Grade A environment; opening an isolation door triggers automatic shutdown.
Especificações técnicas
Especificações da variante: Filling/stoppering machine: capacity 20–50 vials/minute
Especificações
Modelo
SED-50XWGX-A
Capacidade de produção
20–50 frascos/min
Tensão
AC380V±10% 50Hz
Utilidades
AC 380 V ±10%, 50 Hz; insulation resistance >1 MΩ with proper grounding
Detalhes de conformidade
GMP Grade A environment; CRABS Grade 1 isolator protection system. Cleanroom classification C-grade or 100,000-class; temperature 18–28°C; relative humidity 50–65%; filling and sealing zone Grade 100; operating zone air velocity 0.25–0.45 m/s
Potência
5 kW
Dimensões
Comprimento
4600 mm
Largura
1100 mm
Altura
2380 mm
Peso
730 kg
Materiais
Materiais de contato
AISI 304 aço inoxidável; AISI 316 aço inoxidável; 316L stainless steel (filling needles, liquid dividers); FDA-approved materials
Materiais do corpo
45# painted steel frame (Baosteel); 304 stainless steel guard panels; imported PC Grade-100 laminar-flow guard (8 mm)
Características principais
CRABS Grade 1 isolator aseptic protection system
Aseptic filling in Grade A environment; automatic shutdown on door opening
PLC control + touchscreen operation, programmable production
No-vial no-fill function
Centralized lubrication system
Buffer device between single machines for stable inline connection
Filling accuracy ±1% (plunger pump); ±3% (glass mechanical pump)
Stoppering rate ≥99%; capping rate ≥99%; crimp qualification rate ≥99.5%
Vial breakage rate ≤0.1% (filling); ≤0.2% (crimping)
Servo motor driven filling pump; independent servo steering
Electromagnetic oscillating stopper feeder; pneumatic stoppering
Interchangeable capping heads (screw/crimp); adapts to plastic or aluminum caps
Adjustable cap head height for different bottle heights
Air speed, particle, viable/non-viable particle monitoring
Aseptic gloves and integrity testing system
Bottle-tip rejection function; aluminum chip collection/capture device
Fiber-optic crimp counter for automated yield tracking
High-quality AISI 304/AISI 316 stainless steel and FDA-approved contact materials
Purpose-built for small-batch R&D and pilot production; flexibly meets lab and trial manufacturing needs
Three major modules (filling/stoppering, capping/sealing, crimping) operable independently
Complies with GMP Grade A environment requirements
PU synchronous belt + large-modulus gear drive for safe, long-life transmission
Equal-velocity curved cam tracking; filling needle never contacts inner vial wall
Laminar flow frame circular design eliminates sanitary dead angles
Aplicações
Aseptic filling of 2–5 ml vials
Aseptic filling of 20 ml vials
Biologics filling
Liquid pharmaceutical filling
Pre-lyophilization filling and stoppering
Setores
Farmacêutico
Biopharmaceutical
Vaccine
Injectable drugs
Marcas dos componentes
PLC
Delta
Touchscreen
Delta
Inverter
Delta
Intermediate relay
Omron
Solid-state relay
Omron
Inductive proximity switch
Autonics
Main power switch
Meanwell
Frame
Baosteel
Guard panels
Foshan
Bearings
Igus/NSK/Harbin Bearing
Mesh belt motor
Shanghai
Crimping machine PLC
Siemens
Crimping machine touchscreen
Siemens
Crimping machine inverter
ABB
Crimping machine main switch
Schneider
SED
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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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