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SED-3YX-Z
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SED-3YX-Z
SED · SED-3YX-Z · En vedette

SED-3YX-Z — Fully Automatic Rubber Stopper Washing Machine

La description complète de ce modèle est encore en cours de traduction. Consultez les détails en anglais ou demandez des informations à notre équipe. 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

China new GMPEU cGMPUS FDA
Délai de livraison
Sur devis
Cadence
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Fonctionnement

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.

Processus de fonctionnement
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.

Caractéristiques techniques

Caractéristiques de la variante : SED-3YX-Z

Caractéristiques

Modèle
SED-3YX-Z
Tension
380V
Puissance
20 kW
Pression d’air
0.6-0.8 MPa; 0.25 MPa; <-0.095 MPa; 0.16 MPa

Dimensions

Longueur
2700 mm
Largeur
1850 mm
Hauteur
2500 mm
Poids
3000 kg

Matériaux

Matériaux en contact
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)
Matériaux du bâti
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)

Caractéristiques principales

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

Applications

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

Secteurs

Pharmaceutique
Injectable products
Powder/lyophilized/aqueous injections
Large-volume infusions

Marques des composants

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
Échangez avec SED Sales Team
Spécialistes des équipements · contact sur WhatsApp
Consultez les horaires et la disponibilité de l’équipe

Conformité

China new GMP
EU cGMP
US FDA

Documentation

Fiche technique (PDF)
Aperçu de l’équipement, caractéristiques et dimensions · Document d’origine (anglais)
Demander au service commercial
Manuel opérateur
Installation, fonctionnement et dépannage · Document d’origine (anglais)
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Fiche comparative (Standard et Économique)
Comparaison des configurations · Document d’origine (anglais)
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Protocoles IQ / OQ / PQ
Documentation de validation pour la conformité GMP · Document d’origine (anglais)
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Protocoles FAT / SAT
Essais de réception en usine et sur site · Document d’origine (anglais)
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Plans CAD (STEP / IGES / DWG)
Plans d’ingénierie pour l’implantation · Document d’origine (anglais)
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Certificats d’étalonnage
Niveau sonore, résistance de terre, rigidité diélectrique et rugosité · Document d’origine (anglais)
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DQ (qualification de la conception)
Protocole complet de qualification de la conception · Document d’origine (anglais)
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Certificats matières
Composition de l’acier inoxydable 316L · Document d’origine (anglais)
Demander au service commercial
SED
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