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SED-3YX-Z
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SED-3YX-Z
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SED-3YX-Z — Fully Automatic Rubber Stopper Washing Machine
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
SED-3YX-Z Fully Automatic Rubber Stopper Washing Machine for washing, siliconizing, sterilization and drying of rubber stoppers used in powder injections, lyophilized powder injections, aqueous injections, oral liquids a
Prazo de entrega
Consultar
Capacidade de produção
Fale conosco
Como funciona
Rubber stoppers are continuously tumbled inside a slowly rotating wash drum. The combination of high-pressure compressed air flow and boiling water creates physical motion causing stoppers to float, roll and collide softly in the wash medium — the instantaneous deformation and recovery of each stopper breaks the bond between contaminants and the stopper surface. Vacuum degassing causes wash water to flush all surfaces. Saturated pure steam heat-penetration sterilizes bacteria. Vacuum drying combined with heat-exchanger-assisted hot air drying exhausts moisture. Process stages: high-pressure spray + agitation coarse wash; air-water mixed boiling rinse; vacuum degassing wash; self-recirculating water fine wash; sampling inspection; siliconization; water-for-injection rinse; steam moist-heat sterilization; vacuum + heat-exchanger drying.
Processo de funcionamento
1Rubber stoppers are continuously tumbled inside a slowly rotating wash drum.
2The combination of high-pressure compressed air flow and boiling water creates physical motion causing stoppers to float, roll and collide softly in the wash medium — the instantaneous deformation and recovery of each stopper breaks the bond between contaminants and the stopper surface.
3Vacuum degassing causes wash water to flush all surfaces.
4Saturated pure steam heat-penetration sterilizes bacteria.
5Vacuum drying combined with heat-exchanger-assisted hot air drying exhausts moisture.
6Process stages: high-pressure spray + agitation coarse wash; air-water mixed boiling rinse; vacuum degassing wash; self-recirculating water fine wash; sampling inspection; siliconization; water-for-injection rinse; steam moist-heat sterilization; vacuum + heat-exchanger drying.
Especificações técnicas
Especificações da variante: SED-3YX-Z
Especificações
Modelo
SED-3YX-Z
Tensão
380V
Potência
20 kW
Pressão de ar
0.6-0.8 MPa; 0.25 MPa; <-0.095 MPa; 0.16 MPa
Dimensões
Comprimento
2700 mm
Largura
1850 mm
Altura
2500 mm
Peso
3000 kg
Materiais
Materiais de contato
316 stainless steel (wash tank interior wall, Ra≤0.4 μm, full radius transitions, no dead corners); SUS316L (wash drum, interior Ra≤0.4 μm mirror-polished, exterior Ra≤0.8 μm); 316L (discharge spiral guide, fully enclosed discharge system, sampling port); hygienic-grade soft materials (flexible seals)
Materiais do corpo
Silica-alumina fibre wool (chlorine-free) 50 mm thick (interlayer insulation); SS304 (outer cladding, brushed 304 stainless steel sheet); high-quality carbon steel (frame structure, welded)
Características principais
Full compliance with Chinese new GMP, EU cGMP and US FDA washing process
Innovative central spray technology (nationally first water-curtain spray technique)
Simple and practical top automatic loading
Proprietary visible aseptic discharge system (transparent end-face mirror + CIP/SIP capable)
External drum drive + full drum removal for maintenance
Self-recirculating wash water system (multi-stage filtration)
Dual-seal combination (precision mechanical seal + hygienic soft flexible seal)
Active condensate/low-temperature steam auto-drain (angle seat valve + PLC pulsed)
Dual temperature probes + new pressure transmitters; temperature control ±0.5°C
F0 value precise calculation (every 6 seconds; 121°C 15–30 min sterilization)
All actuators with physical position feedback
Wireless validation instrument for heat distribution/penetration verification
Touch-screen discharge control
Advanced control system (Siemens industrial panel + PLC, four-level password + electronic signature + records + audit trail)
Reliable detection instruments (multi-channel patrol inspection, metal analyser, pipeline endoscope)
Nationally patented dual-shaft support structure
Patented new aseptic discharge port design
30,000 stoppers/batch; full integrated process (wash + siliconize + sterilize + dry)
Plate heat exchanger + vacuum drying eliminates sterilization dead zones of traditional hot-air system
316L Ra≤0.4 μm + dual seals + audit trail; compliant with latest GMP/cGMP/FDA
Grade A/B area separation; Class 100 isolation device option for aseptic discharge
Aplicações
Rubber stopper washing for powder injections
Rubber stopper washing for lyophilized powder injections
Rubber stopper washing for aqueous injections
Rubber stopper washing for oral liquids
Rubber stopper washing for large-volume infusions
Rubber stopper siliconization
Rubber stopper steam sterilization
Rubber stopper vacuum drying
Aluminium cap washing and sterilization
Setores
Farmacêutico
Injectable products
Powder/lyophilized/aqueous injections
Large-volume infusions
Marcas dos componentes
PLC CPU 1214C+SM1223+SM1231+12-inch HMI
Siemens
Discharge screen TPC7062Ti
MCGS
Intermediate relay RXM2AB2BD
Schneider
Pneumatic valves
Hebron
Booster pump
GLOBAL
Vacuum pump 2BC5121 7.5kW
Feiyao
Cycloidal gear reducer
Harbison Heavy Gear
Liquid/breathing filters
Cobetter
Mechanical seal
Zhejiang Lantian
Bearings
Harbin Bearing
Interlock cylinders
Conar
Pressure transmitters/PT100
Xun'er
Level switch E2K-C25ME1
Omron
Printer HL2560DN
Brother
Inverter/power supply/switch
Delta
Pure steam pressure gauge
Brady
FRL units/filter pressure reducers
KAIYUAN
Diaphragm/angle seat valves (WFI/PW/steam)
GEMU
SED
Fale com SED Sales Team
Especialistas em equipamentos · contato pelo WhatsApp
Consulte o horário e a disponibilidade da equipe
Conformidade
China new GMP
EU cGMP
US FDA
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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