SED-8-8-4GZX-J
Consultar
SED · SED-8-8-4GZX-J · Destacado
SED-8-8-4GZX-J — Línea de llenado de líquidos
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
The SED-8-8-4GZX-J is a high-speed vial washing-sterilizing-filling-stoppering-capping linkage line for 5 mL (2R) vials at 200 pcs/min (12,000 pcs/hour), built to new GMP and export standards. It comprises: SED-80CXP1-J
Elegir variante (4)
Plazo de entrega
Consultar
Capacidad de producción
297.5–402.5 /(pcs/hour) for 5 ml vial
Funcionamiento
5 mL vials are unpacked, washed by ultrasonic + circulating water + WFI + compressed-air rinse in the washer (600–1,000 W ultrasonic, filter integrity test point), then dried and sterilized in the hot-air tunnel (280–350°C, real-time temperature curve recording, cooling-zone SIP). Sterile vials are conveyed under laminar flow to the filling/stoppering machine where 8 servo-controlled ceramic pumps dispense to ±1% accuracy under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system (≥99.99% stoppering success rate). Stoppered vials pass to the capper where aluminum caps are applied and crimped under another oRABS unit with glove ports and door-open shutdown.
Proceso de funcionamiento
15 mL vials are unpacked, washed by ultrasonic + circulating water + WFI + compressed-air rinse in the washer (600–1,000 W ultrasonic, filter integrity test point), then dried and sterilized in the hot-air tunnel (280–350°C, real-time temperature curve recording, cooling-zone SIP).
2Sterile vials are conveyed under laminar flow to the filling/stoppering machine where 8 servo-controlled ceramic pumps dispense to ±1% accuracy under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system (≥99.99% stoppering success rate).
3Stoppered vials pass to the capper where aluminum caps are applied and crimped under another oRABS unit with glove ports and door-open shutdown.
Especificaciones técnicas
Especificaciones de la variante: SED-80CXP1-J ultrasonic washer (350 pcs/min at 5 mL
Especificaciones
Modelo
SED-8-8-4GZX-J
Capacidad de producción
297.5–402.5 /(pcs/hour) for 5 ml vial
Tensión
380V, 50Hz
Suministros
Power: 380V/50Hz. Compressed air: 0.4–0.6 MPa, 45–50 m³/h. WFI: 0.3–0.5 MPa, 40–60°C, 0.6–0.8 m³/h. Circulating water: 0.3–0.5 MPa. Cooling water for tunnel cooling section. Saturated steam for SIP. Customer to provide forklift/crane and labor for installation.
Detalles de conformidad
Designed and manufactured to new GMP and export standards. Validation documentation (DQ, DS, CCA, IQ, OQ, PQ, OM, MM, FAT, SAT) included with the line.
Presión de aire
0.4-0.6 MPa (compressed air)
Dimensiones
Superficie de instalación
Multi-station line: washer 2280×2200 mm; tunnel 3600×1820 mm; filler 3650×2350 mm; capper 2200×1550 mm. Conveyors between stations priced per meter (finalized after layout drawing approval). Transfer-table height FL+950 mm throughout.
Materiales
Materiales en contacto
Product-contact piping in pharmaceutical-grade stainless steel; ceramic pumps for product filling; sanitary FOUCS pneumatic diaphragm valves on product lines
Materiales del cuerpo
Pharmaceutical-grade stainless steel construction throughout
Características principales
Complete linkage line: ultrasonic washing + hot-air sterilization + servo filling + stoppering + capping
Capacity: 200 pcs/min (12,000 pcs/hour) for 5 mL (2R) vials, one mold set included
Designed to new GMP requirements; manufactured to export standards
Ultrasonic washer: online display/alarm/recording for water/air pressure and temperature; filter integrity test point; isochronous equivalent function
Sterilization tunnel: cooling-zone SIP; glass-scrap collection; real-time temperature curve recording and printing; dehumidification and night-shift modes; 280–350°C range
8 servo-controlled ceramic-pump filling stations: filling accuracy ±1%; stoppering success ≥99.99%
oRABS isolation with FFU, toughened-glass guard, glove ports and door-open shutdown on filling and capping stations
Capping qualification rate ≥99.9%; vial breakage <0.05%; noise <70 dB
Full validation documentation (DQ, DS, CCA, IQ, OQ, PQ, OM, MM, FAT, SAT) + 20-day installation/commissioning service
High-speed 12,000 pcs/h line dedicated to 5 mL vial format
Ceramic-pump filling for excellent accuracy and durability with sterile liquids
oRABS isolators on filling and capping stations for sterile-manufacturing assurance
Cooling-zone SIP in the tunnel for enhanced aseptic operation
Premium component mix: Schneider/NSK/THK/IGUS/Camfil/ABB
Aplicaciones
High-speed sterile filling of 5 mL vials
Vaccine filling
Small-volume parenterals and biologics
Antibiotic powder/liquid vial filling
Sectores
Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing
Marcas de componentes
HMI/PLC/VFD/contactors/relays/servo drive: Schneider (France)
Filling servo motors: Schneider (France)
Optical fibers and amplifiers: Panasonic (Japan)
Bearings: NSK (Japan); CAM bearings: THK (Japan); slide/flange bearings: IGUS (Germany)
Main motors: ABB (USA)
Reducer: Jinggeng (Shanghai); deceleration motor: Taiqi (Shanghai); planetary reducer: Hanxing (Hubei)
Centrifugal pump: CNP (Hangzhou)
Air cylinders, solenoid valves, FRL: Air-tac (Taiwan)
Proximity switches: Contrinex (Switzerland)
Pneumatic diaphragm valves: FOUCS
Heat-resistant filters: Camfil (Sweden); HEPA: SUJING (Suzhou)
Synchronous belts: Megadyne (Italy); ball screws: HIWIN (Taiwan)
Ceramic pump: Jingzhuo (Shenzhen) / Super (Wuxi)
Ultrasonic generator: Dewei (Zhangjiagang)
Gloves: North (USA)
SED
Hable con SED Sales Team
Especialistas en equipos · contacto por WhatsApp
Consulte el horario y la disponibilidad del equipo
Conformidad
Designed to new GMP requirements (China)
Manufactured to export standards
Documentación
Ficha técnica (PDF)
Resumen del equipo, especificaciones y dimensiones · Documento original (inglés)
Solicitar al equipo comercial
Manual del operador
Instalación, funcionamiento y diagnóstico · Documento original (inglés)
Solicitar al equipo comercial
Ficha comparativa (Estándar y Económica)
Comparación de configuraciones · Documento original (inglés)
Solicitar al equipo comercial
Protocolos IQ / OQ / PQ
Documentación de validación para conformidad GMP · Documento original (inglés)
Solicitar al equipo comercial
Protocolos FAT / SAT
Pruebas de aceptación en fábrica y en sitio · Documento original (inglés)
Solicitar al equipo comercial
Planos CAD (STEP / IGES / DWG)
Planos de ingeniería para la instalación · Documento original (inglés)
Solicitar al equipo comercial
Certificados de calibración
Nivel sonoro, resistencia de tierra, rigidez dieléctrica y rugosidad · Documento original (inglés)
Solicitar al equipo comercial
DQ (cualificación del diseño)
Protocolo completo de cualificación del diseño · Documento original (inglés)
Solicitar al equipo comercial
Certificados de materiales
Composición del acero inoxidable 316L · Documento original (inglés)
Solicitar al equipo comercial