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SED-4GZX-J
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SED-4GZX-J
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SED-4GZX-J — Liquid Filling Production Line - Vial Wash-Sterilize-Fill-Cap-Inspect-Label 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-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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Prazo de entrega
Consultar
Capacidade de produção
297.5–402.5 vials/hour (10 ml)
Como funciona
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.
Processo de funcionamento
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.
Especificações técnicas
Especificações da variante: SED-80CXP2-J ultrasonic washer (350 pcs/min @10mL
Especificações
Modelo
SED-4GZX-J
Capacidade de produção
297.5–402.5 vials/hour (10 ml)
Tensão
AC 380V 50Hz (light-inspection station 220V)
Utilidades
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.
Detalhes de conformidade
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.
Pressão de ar
0.4–0.6 MPa compressed air (washer)
Dimensões
Área de instalação
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.
Materiais
Materiais de contato
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
Materiais do corpo
Stainless-steel construction across all six machines; toughened-glass oRABS shields on filling and capping stations
Características principais
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
Aplicações
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
Setores
Pharmaceutical (sterile injectables / parenterals)
Biologics and vaccines
Veterinary injectables
Marcas dos 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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Conformidade
New GMP-compliant
Export standard manufactured (FAT + SAT)
Limpeza e manutenção
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.
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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