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Início / Equipamentos / Seringas pré-cheias / Prefilled Syringe Vacuum Filling and Stoppering Machine (Dual-Head)
SED-2YGF-K
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SED-2YGF-K
SED · SED-2YGF-K · 1 unidades vendidas

SED-2YGF-K — Prefilled Syringe Vacuum 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

SED-2YGF-K Dual-Head Automatic Prefilled Syringe Vacuum Filling and Stoppering Machine. Designed exclusively for aseptic, high-efficiency filling of prefilled syringes (PFS). Compatible with BD, BG, SCHOTT and major dome

GMP compliant
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Prazo de entrega
Consultar
Capacidade de produção
1200–1800 syringes/h

Como funciona

Prefilled syringes (in nest trays) are loaded at a de-nesting station. Sucker-lift and carrier mechanisms extract rows of syringes automatically into the infeed star-wheel, indexing two syringes at a time onto a synchronous belt conveyor. At the filling station, two liquid needles descend into the syringe barrels and rise with the liquid level to prevent splashing; ceramic rotary-valve plunger pumps (servo-driven) meter each dose under vacuum — eliminating bubbles in viscous formulations. Rubber stoppers are sorted by a SUS316L vibratory feeder bowl (clean bright surface, no dead corners) and delivered via stopper track. Dual capping heads flip two stoppers 180° and press them under vacuum into the syringe openings, ensuring flush contact with the liquid surface and zero friction-particle generation. Finished syringes exit via a chute for manual collection. Siemens PLC and HMI coordinate all stations with servo-synchronized motion, real-time station monitoring, automatic alarms, and fault-location display.

Processo de funcionamento
1Prefilled syringes (in nest trays) are loaded at a de-nesting station.
2Sucker-lift and carrier mechanisms extract rows of syringes automatically into the infeed star-wheel, indexing two syringes at a time onto a synchronous belt conveyor.
3At the filling station, two liquid needles descend into the syringe barrels and rise with the liquid level to prevent splashing; ceramic rotary-valve plunger pumps (servo-driven) meter each dose under vacuum — eliminating bubbles in viscous formulations.
4Rubber stoppers are sorted by a SUS316L vibratory feeder bowl (clean bright surface, no dead corners) and delivered via stopper track.
5Dual capping heads flip two stoppers 180° and press them under vacuum into the syringe openings, ensuring flush contact with the liquid surface and zero friction-particle generation.
6Finished syringes exit via a chute for manual collection.
7Siemens PLC and HMI coordinate all stations with servo-synchronized motion, real-time station monitoring, automatic alarms, and fault-location display.

Especificações técnicas

Especificações da variante: SED-2YGF-K dual-head prefilled syringe vacuum filler and stopperer

Especificações

Modelo
SED-2YGF-K
Capacidade de produção
1200–1800 syringes/h
Tensão
380V/220V 50-60Hz
Utilidades
Power: 380V/220V, 50–60 Hz, 3.5 kW total. Compressed air: 0.55–0.75 MPa, 15 L/s. Vacuum pump (VALUE, optionally BUSCH) — dedicated unit included.
Detalhes de conformidade
Surface SUS304, contact parts SUS316L stainless steel and medical silicon rubber — fully meets GMP specifications. Vibratory feeder uses SUS316L clean plate with bright surface and no dead corners. Seaworthy export wooden case packing. IQ/OQ/PQ validation documents provided.
Potência
3.5 kW
Pressão de ar
0.55-0.75 MPa, 15 L/s

Dimensões

Comprimento
1020 mm
Largura
800 mm
Altura
1735 mm
Peso
350 kg
Área de instalação
1020 × 800 × 1735 mm (L × W × H), 350 kg. Additional space required if optional nesting machine and laminar flow hood are installed.

Materiais

Materiais de contato
SUS316L aço inoxidável; medical silicone rubber; ceramic (plunger pump)
Materiais do corpo
SUS304 stainless steel (surface and frame); SUS316L stainless steel (contact parts); SUS316L clean plate (vibratory feeder)

Características principais

Dual filling heads + dual capping heads
Throughput 1200–1800 syringes/h
Filling accuracy ≤±1–2%
Compatible with 0.5, 1, 2.25, 3, 5, 10, 20 mL syringes
Compatible with BD, BG, SCHOTT and major domestic SCF (prefilled syringe) syringes
Ceramic plunger pump (acid/alkali resistant, wear-resistant, high-temperature)
Vacuum filling system — no bubbles for viscous materials
Vacuum stoppering system — no particles from stopper friction
SUS316L vibratory feeder with clean bright surface and no dead corners
Liquid-level-rising filling needle — prevents splashing
Servo-motor synchronized indexing
Siemens PLC + HMI with real-time fault display and alarms
Modular design: standalone or in-line
Multiple filling doses and filling methods
Optional hundred-level laminar flow hood
GMP compliant
IQ/OQ/PQ validation documentation included
Seaworthy export packaging
BD/BG/SCHOTT compatible — universal SCF syringe support across all major suppliers
Vacuum filling + vacuum stoppering = bubble-free, particle-free aseptic fills
Aseptic, GMP-compliant for sterile injectable and biopharmaceutical PFS production
Modular — integrates into a complete PFS line (nesting + plunger-rod + labeling + inspection)
Premium named-brand components: Siemens, Omron, Mean Well, AirTAC, Value
Customizable for non-standard syringe types
12-month warranty after installation
Comes with full IQ/OQ/PQ validation package

Aplicações

Prefilled syringe filling (liquid)
Prefilled syringe filling (ointment/viscous)
Aseptic injectable drug filling
Biopharmaceutical PFS filling
Vaccine PFS filling
Heparin PFS filling
Insulin PFS filling

Setores

Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing
Medical device (prefilled syringe)

Marcas dos componentes

Siemens (HMI, PLC, servo motor) — standard
OMRON (small relay, proximity switch, photoelectric sensor); Schneider/Panasonic optional
CHINT (contactor, pushbutton, air circuit breaker); Schneider optional
MEAN WELL (switching power supply); Schneider optional
BALE (speed motor); JSCC optional
AirTAC (solenoid valve, cylinder); SMC optional
XINCI (filling pump); JINGZHUO optional
VALUE (vacuum pump); BUSCH optional
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Conformidade

GMP compliant

Limpeza e manutenção

Modular design with no dead corners (SUS316L vibratory feeder, bright clean surface). Ceramic plunger pump is acid/alkali resistant for chemical cleaning agents. Disassemble product-contact parts for sterilization between batches per GMP cleaning SOPs.

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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