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SED-6-10GZX-J
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SED-6-10GZX-J
SED · SED-6-10GZX-J · Em destaque
SED-6-10GZX-J — Vial Washing, Sterilizing, Filling, Stoppering and Capping Linkage Line
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
The SED-6-10GZX-J is a complete vial washing-sterilizing-filling-stoppering-capping linkage line designed for 100 mL vials at 3,000 pcs/hour, built to new GMP requirements and export standards. The line consists of an SE
Escolher variante (4)
Prazo de entrega
Consultar
Capacidade de produção
2975–4025 /(pcs/hour) for 100 ml vial
Como funciona
Vials are unpacked and fed into the ultrasonic washer (cycle water rinse × 2 → WFI rinse → compressed air purge cycles). Washed vials enter the hot-air sterilization tunnel (mesh belt 100–400 mm/min, 280–350°C, water-cooled exit zone, real-time temperature curve recording). Sterilized vials transfer to the servo filling-stoppering machine where 6 servo-controlled peristaltic pumps fill under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system. Stoppered vials then enter the capping machine under a second oRABS isolator with aluminum cap feeder and scrap collection. Transfer table height FL+950 mm throughout.
Processo de funcionamento
1Vials are unpacked and fed into the ultrasonic washer (cycle water rinse × 2 → WFI rinse → compressed air purge cycles).
2Washed vials enter the hot-air sterilization tunnel (mesh belt 100–400 mm/min, 280–350°C, water-cooled exit zone, real-time temperature curve recording).
3Sterilized vials transfer to the servo filling-stoppering machine where 6 servo-controlled peristaltic pumps fill under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system.
4Stoppered vials then enter the capping machine under a second oRABS isolator with aluminum cap feeder and scrap collection.
5Transfer table height FL+950 mm throughout.
Especificações técnicas
Especificações da variante: SED-40CXP-J ultrasonic washer (3
Especificações
Modelo
SED-6-10GZX-J
Capacidade de produção
2975–4025 /(pcs/hour) for 100 ml vial
Tensão
380V, 50Hz
Utilidades
Power: 380V 50Hz. Compressed air 0.4–0.6 MPa, ~45–50 m³/h. WFI 0.3–0.5 MPa, 40–60°C, 0.4–0.5 m³/h. Circulating water 0.3–0.5 MPa. Cooling water for tunnel cooling section. Customer to provide forklift/crane and labor for installation.
Detalhes de conformidade
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.
Pressão de ar
0.4-0.6 MPa (compressed air)
Dimensões
Área de instalação
Multi-station line. Main equipment footprints: washer 2280×2200 mm, tunnel 6500×2220 mm, filler 4120×1680 mm, capper 2200×1550 mm. Transfer table height FL+950 mm throughout. Inter-machine conveyors priced per meter after layout confirmation.
Materiais
Materiais de contato
Product-contact piping in 316L stainless steel (pharmaceutical grade); peristaltic-pump tubing for filling; sanitary pneumatic diaphragm valves (FOUCS) on product lines
Características principais
Complete linkage line: washing + sterilization + filling + stoppering + capping
Capacity: 3,000 pcs/hour for 100 mL vials (one specification mold set included)
Designed to new GMP requirements; manufactured to export standards
Ultrasonic washer SED-40CXP-J: online display/alarm/record for water pressure, air pressure and temperature; filter integrity test point; automatic plexiglass cover lifting; ultrasonic 600–1,000 W adjustable
Sterilization tunnel SED-80RXG-J: water-cooled cooling zone; real-time printable temperature curve; PAO/DOP test point; dehumidification and night-shift modes; 280–350°C adjustable
Servo filling-stoppering SED-6XGS-J: 6 servo-controlled peristaltic pumps, ±1% accuracy; no-bottle-no-fill; oRABS with FFU; toughened glass guard; glove ports; door-open shutdown
Capping machine SED-ZG-J: bottle arranging table; inverted-bottle auto-rejection; no-bottle-no-cap; oRABS with FFU; aluminum scrap collector; door-open shutdown
Stoppering success rate ≥99.99%; capping qualified rate ≥99.9%; vial breakage rate <0.01–0.05%
Full validation documentation (DQ/DS/CCA/IQ/OQ/PQ/OM/MM/FAT/SAT) included
20-day on-site installation and commissioning service included
Turn-key vial line for 100 mL format with one mold set included
Built to new GMP and export standards with full Schneider/Siemens-class controls
oRABS isolators on filling and capping for sterile assurance
Premium component brands: Schneider, NSK, THK, IGUS, Camfil, ABB, Panasonic
Validation documentation (DQ through SAT) included in the offer
Aplicações
Sterile vial filling for liquid injectables
Pharmaceutical small-volume parenterals (100 mL format)
Vaccines, biologics and other aseptic liquid products
Setores
Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing
Marcas dos componentes
HMI / PLC / VFD / contactors / relays
Schneider
Optical fibers and amplifiers
Panasonic
Bearings
NSK
CAM bearings
THK
Slide / flange bearings
IGUS
Main motors
ABB
Reducer (washer / tunnel)
Jinggeng
Deceleration motors
Taiqi
Centrifugal pump
CNP
Air cylinders / solenoid valves / FRL
Airtac
Proximity switches
Contrinex
Pneumatic diaphragm valves
FOUCS
Heat-resistant HEPA filters (tunnel)
Camfil
HEPA filters (FFU)
SUJING
Servo drive and motor (filling)
Schneider
Planetary reducer (filling servo)
Hanxing
Synchronous belts
Megadyne
Ball screws
HIWIN
Peristaltic pump
Signal
Ultrasonic generator
Dewei
Stainless steel mesh belt (washer/tunnel)
Shenwang
FFU fan (isolators)
Duoyili
FFU HEPA filter (isolators)
Huatai
Gloves (isolators)
Snow Lotus
Capping machine main motor
Deli
Capping reducer
TQG
Paper recorder (tunnel)
Meacon
Solid state relay (tunnel)
SHIMADEN
SED
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Conformidade
Designed to new GMP requirements (China)
Manufactured to export standards
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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