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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

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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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Plazo de entrega
Consultar
Capacidad de producción
1200–1800 syringes/h

Funcionamiento

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.

Proceso de funcionamiento
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.

Especificaciones técnicas

Especificaciones de la variante: SED-2YGF-K dual-head prefilled syringe vacuum filler and stopperer

Especificaciones

Modelo
SED-2YGF-K
Capacidad de producción
1200–1800 syringes/h
Tensión
380V/220V 50-60Hz
Suministros
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.
Detalles de conformidad
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.
Potencia
3.5 kW
Presión de aire
0.55-0.75 MPa, 15 L/s

Dimensiones

Longitud
1020 mm
Anchura
800 mm
Altura
1735 mm
Peso
350 kg
Superficie de instalación
1020 × 800 × 1735 mm (L × W × H), 350 kg. Additional space required if optional nesting machine and laminar flow hood are installed.

Materiales

Materiales en contacto
SUS316L acero inoxidable; medical silicone rubber; ceramic (plunger pump)
Materiales del cuerpo
SUS304 stainless steel (surface and frame); SUS316L stainless steel (contact parts); SUS316L clean plate (vibratory feeder)

Características principales

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

Aplicaciones

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

Sectores

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

Marcas de 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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Conformidad

GMP compliant

Limpieza y mantenimiento

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.

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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