SED-8-8-4GZX-J
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SED-8-8-4GZX-J — Linha de envase de líquidos
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. 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
Escolher variante (4)
Prazo de entrega
Consultar
Capacidade de produção
297.5–402.5 /(pcs/hour) for 5 ml vial
Como funciona
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.
Processo de funcionamento
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.
Especificações técnicas
Especificações da variante: SED-80CXP1-J ultrasonic washer (350 pcs/min at 5 mL
Especificações
Modelo
SED-8-8-4GZX-J
Capacidade de produção
297.5–402.5 /(pcs/hour) for 5 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, 0.6–0.8 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.
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: 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.
Materiais
Materiais de contato
Product-contact piping in pharmaceutical-grade stainless steel; ceramic pumps for product filling; sanitary FOUCS pneumatic diaphragm valves on product lines
Materiais do corpo
Pharmaceutical-grade stainless steel construction throughout
Características principais
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
Aplicações
High-speed sterile filling of 5 mL vials
Vaccine filling
Small-volume parenterals and biologics
Antibiotic powder/liquid vial filling
Setores
Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing
Marcas dos 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
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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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