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SED-1YX-K
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SED-1YX-K
SED · SED-1YX-K · Hervorgehoben
SED-1YX-K — Rubber Stopper Washing Machine
Die vollständige Beschreibung dieses Modells wird noch übersetzt. Lesen Sie die englischen Details oder fragen Sie unser Team nach weiteren Informationen. English
Fully automatic rubber stopper washing and drying machine (4th generation). Designed per China GMP, EU cGMP, and US FDA standards. Washing, rinsing, drying, and cooling all completed in a single closed chamber, eliminati
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Durchsatz
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Funktionsweise
Rubber stoppers are loaded via the inlet into the rotating cleaning drum. Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge. Entire process controlled by PLC; parameters preset via touchscreen. Three modes: automatic, semi-automatic, and manual.
Prozessbeschreibung
1Rubber stoppers are loaded via the inlet into the rotating cleaning drum.
2Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge.
3Entire process controlled by PLC; parameters preset via touchscreen.
4Three modes: automatic, semi-automatic, and manual.
Technische Daten
Technische Daten für Variante: SED-1YX-K
Technische Daten
Modell
SED-1YX-K
Spannung
AC 50Hz, 380V
Versorgung
Pure water: pressure ≥ 0.25 MPa, approx. 400 kg/batch; WFI: pressure ≥ 0.25 MPa, approx. 400 kg/batch; compressed air: 0.6–0.8 MPa, 2.0 m³; electricity: AC 50 Hz, 380 V, total power approx. 28 kW. Piping: main inlet DN=25 mm, secondary inlet DN=25 mm, upper discharge DN=100 mm, drain DN=50 mm.
Konformitätsangaben
Designed and manufactured per China GMP standard; materials,surface finish,rounded transitions,process piping welds,and installation fully comply with GMP. Cross-referenced against EU cGMP and US FDA standards. Equipment establishes complete production and quality control records,traceable and auditable. Supports electronic signature and three-level password management.
Leistung
28 kW
Luftdruck
0.6-0.8MPa/2.0m³
Abmessungen
Länge
1800 mm
Breite
1600 mm
Höhe
1800 mm
Gewicht
1800 kg
Aufstellfläche
Overall dimensions: 1,800 × 1,600 × 1,800 mm. Requires: pure water ≥ 0.25 MPa / 400 kg; water for injection ≥ 0.25 MPa / 400 kg; compressed air 0.6–0.8 MPa / 2.0 m³; AC 50 Hz, 380 V power.
Werkstoffe
Kontaktwerkstoffe
316L stainless steel (cleaning drum); 304 stainless steel (cleaning tank, feed/discharge hopper, piping); PTFE (Teflon) gaskets and seals; medical silicone rubber seals; PDFE/PVDF as needed
Gehäusewerkstoffe
Carbon steel frame; 304 stainless steel brushed plate (housing,thermal insulation cover); chlorine-free aluminum silicate rock wool insulation
Wesentliche Merkmale
Washing, rinsing, drying, and cooling in a single closed chamber
Eliminates cross-contamination
PLC + color LCD touchscreen control; full Chinese/English switchable interface
Three-level password authorization management (operator / process engineer / manager)
Electronic signature and electronic records (USB print supported)
Capacity: 10,000 Φ20 rubber stoppers per batch
Drum rotational speed: 0.5–10 rpm (variable frequency, stepless)
Advanced ultrasonic cleaning with vacuum degassing
Self-circulating fine wash (water-saving)
Hot-air drying: 70–150°C
Interior surface finish: Ra ≤ 0.4 µm
316L stainless steel cleaning drum with spiral guide plates for auto-discharge
External drum drive (bearing outside cleaning tank) — prevents contamination
212B-65 acid/alkali-resistant hard alloy + PTFE double mechanical seal
Insulation: chlorine-free aluminum silicate rock wool; outer cover 304 SS brushed plate
Compliant with China GMP, EU cGMP, US FDA standards
4th-generation product — proven over 10+ years, deployed in 30+ provinces nationwide and exported internationally
Fully closed single-pass process eliminates cross-contamination
Self-circulating fine wash significantly reduces water consumption
Online monitoring, detection, and control; traceable electronic records
Compliant with China GMP, EU cGMP, and US FDA standards
Capacity 10,000 stoppers/batch; drum speed 0.5–10 rpm (VFD stepless)
Anwendungen
Rubber stopper cleaning and drying
Aluminum cap cleaning
Pharmaceutical injectable component cleaning
Branchen
Pharmaceutical injectable manufacturing
Antibiotic powder injection
Water for injection (WFI) production
Komponentenhersteller
Siemens — PLC and color LCD touchscreen
Schneider — AC contactor (LC1N0610), thermal overload relay (CDG3-DA), relay (RXM2ABABD), power supply, rotary switch, signal lights and buttons
Delta — inverter/frequency converter
Wolken — external mechanical seal (212B-65,acid/alkali-resistant hard alloy + PTFE)
Jiangsu Changzhou — cycloidal pin-wheel reducer (BWD131-289, motor 1.1 kW)
Qingdao — blower fan (DE-160, 380V/1.1 kW)
Nanfang Pump Industry (Hangzhou joint venture) — cleaning water pump (8-30)
Wenzhou suppliers — sanitary thin-wall stainless steel piping (304 SS), quick-release clamps, silicone gaskets, fittings
SED
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Konformität
GMP (China)
cGMP (EU)
FDA (US) standard reference
Reinigung und Wartung
All process steps (washing, rinsing, drying, cooling) complete automatically in sequence. The cleaning drum interior and spiral guides have Ra ≤ 0.4 µm mirror finish; tank interior Ra ≤ 0.4 µm. Self-circulating fine wash uses pump + filtration to recirculate cleaning water through center spray. After each batch, drainage via electromagnetic valve; drum reverse-rotation for automatic discharge. Maintenance access via side and rear doors; large-diameter discharge opening doubles as manhole for internal cleaning.
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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