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SED-25YX-Z
Sur devis
SED-25YX-Z
SED · SED-25YX-Z · En vedette

SED-25YX-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-25YX-Z Fully Automatic Rubber Stopper Washing Machine — special pharmaceutical equipment for washing, siliconizing, sterilizing and drying rubber stoppers used in powders, freeze-dried powders, water injections, oral

GMP (2010)EU CGMPUS FDA
Délai de livraison
Sur devis
Cadence
200000–250000 pcs/batch

Fonctionnement

Rubber stoppers tumble continuously inside the slowly rotating wash drum. High-pressure compressed air flow and boiling water create physical motion that suspends and softly collides the stoppers, causing momentary deformation and recovery that breaks the bond between contaminants and the stopper surface. Vacuum degassing draws wash water into all crevices. Saturated pure steam provides heat-penetration sterilization. Vacuum drying combined with plate-heat-exchanger hot-air drying removes residual moisture.

Processus de fonctionnement
1Rubber stoppers tumble continuously inside the slowly rotating wash drum.
2High-pressure compressed air flow and boiling water create physical motion that suspends and softly collides the stoppers, causing momentary deformation and recovery that breaks the bond between contaminants and the stopper surface.
3Vacuum degassing draws wash water into all crevices.
4Saturated pure steam provides heat-penetration sterilization.
5Vacuum drying combined with plate-heat-exchanger hot-air drying removes residual moisture.

Caractéristiques techniques

Caractéristiques de la variante : SED-25YX-Z

Caractéristiques

Modèle
SED-25YX-Z
Cadence
200000–250000 pcs/batch
Tension
380V
Fluides et énergie
Purified water ≈3000 kg; water for injection ≈1500 kg; pure steam 0.25 MPa ≈210 kg; compressed air 0.6–0.8 MPa × 2.0 m³; vacuum <−0.095 MPa; power supply 380 V 25 kW; power line 4+PE 16 mm² / 7+PE 4 mm² / 20+PE 2.5 mm² / control line 60+PE 1 mm².
Détails de conformité
Compliant with GMP-2010 + EU CGMP + US FDA; all full-arc transitions with no dead zones or residue; pipelines sanitary-polished inside and out, fully automatic TIG welding with high-purity argon protection; electronic signature / electronic records / audit trail / data integrity; F0 calculated every 6 seconds; 121°C × 15–30 min sterilization; empty/loaded heat distribution and penetration ≤±1°C; drying temperature 110–130°C; discharge temperature ≤60°C.
Puissance
25 kW
Pression d’air
0.6~0.8 MPa (compressed air); 0.25 MPa (pure steam)

Dimensions

Longueur
3850 mm
Largeur
2400 mm
Hauteur
2700 mm
Poids
5500 kg
Emprise au sol
Machine footprint: 3850 × 2400 mm (L×W); overall height 2700 mm. Inlet port diameter Ø150 mm.

Matériaux

Matériaux en contact
Wash drum: 316L stainless steel (inner surface Ra≤0.4 μm mirror-polished, outer Ra≤0.8 μm; 4 spiral guide plates); wash tank inner wall: 316 SS Ra≤0.4 μm; discharge spiral guide / fully enclosed discharge system / sample port: 316L; mechanical seal: high-precision acid-alkali-resistant hard alloy steel + PTFE dual seal; gaskets: silicone rubber / sanitary-grade flexible material.
Matériaux du bâti
Frame: high-quality carbon steel welded; outer casing: 304 SS brushed plate; jacket insulation: 50 mm chloride-free aluminium silicate wool (outer layer 304 SS plate).

Caractéristiques principales

New water-curtain central spray technology (laser-cut water-curtain slot)
Top vacuum automatic feeding — prevents stopper jamming in feed pipe
Visualized aseptic discharge system (transparent sight glass + high-pressure spray + pure steam pipeline + independent nozzle), supports CIP/SIP
Dual-shaft support structure (patented) — eliminates drag friction risk
Integral pull-out wash drum for easy cleaning and maintenance
Plate-heat-exchanger assisted drying (replaces traditional electric heating tubes and HEPA filters)
Grundfos pump self-circulation + two-stage water filtration
Dual-seal assembly (high-precision mechanical seal + sanitary-grade flexible-material soft seal)
PLC automatic drain-valve control (condensate pulse one-way auto-discharge)
Dual thermal-resistance PT100 temperature probes + new-type pressure transducer
F0 value calculated every 6 seconds (upgraded from legacy 60 seconds)
All actuators with physical position feedback
Class A area touchscreen control at discharge side
PLC four-level password access + electronic signature + electronic records
USB data export interface
Power-failure auto-protection (all doors remain sealed automatically on power loss)
Brother laser printer real-time prints curves/data
Optional class 100 protective isolation device
Audit trail (data integrity compliant)
Fully compliant with GMP 2010 + EU CGMP + US FDA standards
Drying temperature 110–130°C; empty/loaded heat distribution and penetration ≤±1°C
Discharge temperature ≤60°C
F0 precise calculation: 121°C, 15–30 min
Installed in 30+ provinces, municipalities and autonomous regions across China, plus overseas export
Electrical control main components: Siemens + Schneider (German brands); pumps: Grundfos; valves: Gemi + Hebron
Water-saving (plate-heat-exchanger drying significantly more energy-efficient than traditional hot-air drying)
12-month warranty from installation (max 16 months from delivery)
Lifetime maintenance support

Applications

Rubber stopper washing for powder-injection vials
Rubber stopper washing for freeze-dried powder-injection vials
Rubber stopper washing for water-injection vials
Rubber stopper washing for oral liquid bottles
Rubber stopper washing for large-volume infusion bottles
Stopper siliconizing, sterilization, and drying

Secteurs

Pharmaceutique

Marques des composants

PLC CPU 1214C / SM1223 / SM1231 modules
Siemens
HMI 12-inch touchscreen (6AV2124-0GC01)
Siemens
Discharge-side 7-inch HMI (TPC7062Ti)
MCGS
Circuit breakers / contactors / outlets
Siemens
Intermediate relay (RXM2AB2BD)
Schneider
Pressure transducer / PT100
Xuner
Level switch (E2K-C25ME1)
Omron
Printer (HL2560DN)
Brother
Inverter (VFD13AMS43AFSAA)
Delta
Switching power supply (DRP024V120W1AA)
Delta
Industrial switch (DVS-005W01)
Delta
Pneumatic valves
Hebron
Manual ball / sample / horizontal trap valves
Wenzhou
Vertical steam trap
Sino-Tech
Safety valve (A27W-16RL)
Zhejiang Haiyi
Pressure-reducing valve (CY14H)
Zhejiang Yongjiu
Air-source filter-regulator-lubricator (AFR2000/BC-4000)
KAIYUAN
Pure-steam pressure gauge (PYTHN-063)
Brighty
Plate heat exchanger (B10TH)
SWEP
Booster pump (multi-stage)
GLOBAL
Vacuum pump 2BC5121 7.5 kW
Feiyao
Cycloidal speed reducer
Harbin Heavy-duty Gear Transmission
Liquid filter / 226-interface breather
Cobetter
Upper breather (5-inch)
Wenzhou
Mechanical seal
Zhejiang Lantian
Bearings
Harbin Bearing
Discharge/feed door interlock cylinders (SA12×10 / SADA16×20S)
Kangkena
Water pump (select configuration)
Grundfos
Diaphragm / seat valves
Gemi
Compressed air filter
Millipore
SED
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Conformité

GMP (2010)
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)
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