Inicio / Equipos / Línea de llenado de líquidos de 4 cabezales / Liquid Filling Production Line - Vial Wash-Sterilize-Fill-Cap-Inspect-Label Linkage Line
SED-4GZX-J
Consultar
SED-4GZX-J
SED · SED-4GZX-J · Destacado
SED-4GZX-J — Liquid Filling Production Line - Vial Wash-Sterilize-Fill-Cap-Inspect-Label Linkage Line
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
The SED-4GZX-J is a complete vial washing-sterilization-filling-stoppering-capping-labeling linkage line for 5-20 mL tubular glass vials, designed at 6,000 vials/hour for 10 mL vials (350 pcs/min washer throughput). The
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Plazo de entrega
Consultar
Capacidad de producción
297.5–402.5 vials/hour (10 ml)
Funcionamiento
Vials enter the SED-80CXP2-J ultrasonic washer for six-stage internal cleaning: recirculating water x2, CA blow, WFI rinse, CA blow, CA blow; external: recirculating water + CA blow. Clean vials transfer to the SED-110RXG-J hot-air tunnel for dry-heat sterilization and depyrogenation at 280-350 degrees C (water-cooled cooling zone). Sterile vials pass under oRABS isolation into the SED-4XGS-J servo filling/stoppering machine where four ceramic-pump heads fill each vial and rubber stoppers are inserted. The SED-20ZG-J crimping/capping machine applies aluminum crimp caps. Capped vials proceed to the SED-GJ-J automated light-inspection station for defect detection, and finally to the SED-BTB-J labeler. Each machine runs servo or VFD drives for synchronized throughput.
Proceso de funcionamiento
1Vials enter the SED-80CXP2-J ultrasonic washer for six-stage internal cleaning: recirculating water x2, CA blow, WFI rinse, CA blow, CA blow; external: recirculating water + CA blow.
2Clean vials transfer to the SED-110RXG-J hot-air tunnel for dry-heat sterilization and depyrogenation at 280-350 degrees C (water-cooled cooling zone).
3Sterile vials pass under oRABS isolation into the SED-4XGS-J servo filling/stoppering machine where four ceramic-pump heads fill each vial and rubber stoppers are inserted.
4The SED-20ZG-J crimping/capping machine applies aluminum crimp caps.
5Capped vials proceed to the SED-GJ-J automated light-inspection station for defect detection, and finally to the SED-BTB-J labeler.
6Each machine runs servo or VFD drives for synchronized throughput.
Especificaciones técnicas
Especificaciones de la variante: SED-80CXP2-J ultrasonic washer (350 pcs/min @10mL
Especificaciones
Modelo
SED-4GZX-J
Capacidad de producción
297.5–402.5 vials/hour (10 ml)
Tensión
AC 380V 50Hz (light-inspection station 220V)
Suministros
Electrical: 380V 50Hz three-phase across the line (220V on light-inspection station). Total installed power roughly 70-75 kW (washer 11 kW + tunnel 47.3 kW + filling 8 kW + capping 2.8 kW + inspection). Compressed air: 0.4-0.6 MPa for washer CA wash stages. WFI (water for injection) for washer final rinse stage. Cooling water for tunnel water-cooled cooling zone.
Detalles de conformidad
Designed to meet new GMP regulations and manufactured to export standards. Validation documentation (DQ, IQ, OQ, PQ, OM, MM, FAT, SAT) included. oRABS isolation systems on the filling/stoppering station provide enhanced aseptic processing. (PAO)/DOP test ports on tunnel; negative-pressure sealing; real-time temperature curve logging.
Presión de aire
0.4–0.6 MPa compressed air (washer)
Dimensiones
Superficie de instalación
Approximate footprints: Washer 2280x2200x1450 mm; Sterilization tunnel 2600x1820x2240 mm; Filling/stoppering 2120x2350x2500 mm; Capping 2200x1550x2500 mm; Light-inspection 2200x880x1280 mm; Labeling (TBD). Total line length approx. 12-15 m.
Materiales
Materiales en contacto
Pharmaceutical-grade stainless steel throughout product-contact zones; SUS304 mesh belts and chamber surfaces; ceramic pumps for filling (SUPER brand); FOUCS sanitary pneumatic diaphragm valves
Materiales del cuerpo
Stainless-steel construction across all six machines; toughened-glass oRABS shields on filling and capping stations
Características principales
Complete 6-machine linkage line: wash -> sterilize -> fill/stopper -> cap -> inspect -> label
6,000 vials/hour throughput for 10 mL tubular glass vials (5-20 mL range)
Six-stage ultrasonic + WFI + CA internal wash on washer
280-350 degrees C adjustable hot-air dry-heat sterilization tunnel (water-cooled cooling zone)
oRABS isolation system and toughened-glass guards on filling/stoppering station
Servo-controlled ceramic-pump filling (SUPER); 2-10 mL range per pump, 4 heads
Automated light-inspection station with auto reject
Siemens HMI/PLC; Schneider drives, VFDs, contactors; ABB motors; NSK bearings
Validation documentation: DQ, IQ, OQ, PQ, FAT, SAT
Turnkey sterile-injectable line - single-vendor responsibility for six integrated machines
Built to new GMP and export standards for direct deployment in regulated markets
oRABS isolator on filling station for enhanced aseptic protection
Comprehensive validation package (DQ through SAT) included
Premium component brands: Siemens, Schneider, ABB, NSK, FOUCS
Aplicaciones
Sterile injectable pharmaceutical filling for tubular glass vials (5-20 mL)
Vaccine, biologic, and lyophilization-precursor liquid filling
Antibiotic and small-molecule injectable production
Veterinary injectable filling
Sectores
Pharmaceutical (sterile injectables / parenterals)
Biologics and vaccines
Veterinary injectables
Marcas de componentes
Siemens - HMI and PLC (Germany)
Schneider - VFD, contactors, relays, servo drives + filling servo motors, e-stop (France)
ABB - motors (used on washer)
NSK - bearings
FOUCS - sanitary pneumatic diaphragm valves
SUPER - ceramic pumps
SED
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Conformidad
New GMP-compliant
Export standard manufactured (FAT + SAT)
Limpieza y mantenimiento
All product-contact surfaces are stainless steel suitable for CIP/wipe-down to GMP protocols. The washer continuously self-cleans via its WFI/CA cycle; the sterilization tunnel includes an ultrasonic mesh-belt cleaning device. Filling station surfaces cleaned per GMP SOPs before and after each batch.
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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