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SED-25YX-Z
Auf Anfrage
SED-25YX-Z
SED · SED-25YX-Z · Hervorgehoben
SED-25YX-Z — Fully Automatic Rubber Stopper Washing Machine
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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
Lieferzeit
Auf Anfrage
Durchsatz
200000–250000 pcs/batch
Funktionsweise
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.
Prozessbeschreibung
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.
Technische Daten
Technische Daten für Variante: SED-25YX-Z
Technische Daten
Modell
SED-25YX-Z
Durchsatz
200000–250000 pcs/batch
Spannung
380V
Versorgung
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.
Konformitätsangaben
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.
Leistung
25 kW
Luftdruck
0.6~0.8 MPa (compressed air); 0.25 MPa (pure steam)
Abmessungen
Länge
3850 mm
Breite
2400 mm
Höhe
2700 mm
Gewicht
5500 kg
Aufstellfläche
Machine footprint: 3850 × 2400 mm (L×W); overall height 2700 mm. Inlet port diameter Ø150 mm.
Werkstoffe
Kontaktwerkstoffe
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.
Gehäusewerkstoffe
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).
Wesentliche Merkmale
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
Anwendungen
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
Branchen
Pharma
Komponentenhersteller
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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Konformität
GMP (2010)
EU CGMP
US FDA
Dokumentation
Datenblatt (PDF)
Überblick, technische Daten und Abmessungen · Originaldokument (Englisch)
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Bedienhandbuch
Einrichtung, Betrieb und Fehlersuche · Originaldokument (Englisch)
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Vergleichsdatenblatt (Standard und Economy)
Vergleich der Konfigurationen · Originaldokument (Englisch)
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IQ / OQ / PQ-Protokolle
Validierungsunterlagen zur GMP-Konformität · Originaldokument (Englisch)
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FAT / SAT-Protokolle
Abnahmeprüfungen im Werk und vor Ort · Originaldokument (Englisch)
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CAD-Zeichnungen (STEP / IGES / DWG)
Konstruktionszeichnungen für die Aufstellung · Originaldokument (Englisch)
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Kalibrierzertifikate
Schallpegel, Erdungswiderstand, Spannungsfestigkeit und Rauheit · Originaldokument (Englisch)
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DQ (Designqualifizierung)
Vollständiges Designqualifizierungsprotokoll · Originaldokument (Englisch)
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Werkstoffzeugnisse
Zusammensetzung des Edelstahls 316L · Originaldokument (Englisch)
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