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SED-2YX-R
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SED-2YX-R
SED · SED-2YX-R · Hervorgehoben
SED-2YX-R — Fully Automatic Rubber Stopper & Aluminum Cap Ultrasonic Washer
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SED-2YX-R Fully Automatic Rubber Stopper Ultrasonic Washer (4th generation). Pharmaceutical equipment for cleaning, sterilizing and drying rubber stoppers, lyophilized stoppers, aluminum caps, and composite caps used in
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Durchsatz
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Funktionsweise
Stoppers/caps tumble in a slow-rotating wash drum (0.5–10 rpm VFD adjustable) inside a 135°C-rated wash tank (-0.1 to 0.25 MPa pressure). Process steps: (1) High-pressure spray + agitation pre-wash via central spray pipe + spiral guide vanes; (2) Gas-water mixed boiling rinse — bottom compressed-air injectors create bursting bubbles that micro-deform stoppers; (3) Ultrasonic + vacuum debubbling — bubbles in stopper crevices burst, allowing wash water in; (4) Self-circulating fine wash via Nanfang pump and inline filter; (5) Water sampling for QC; (6) WFI rinse; (7) Dry-heat sterilization (Fo ≥ 30 min adjustable) at 135°C with stainless heater coil + Class-100 HEPA hot-air circulation; (8) Cooling via Class-100 fresh air through 0.22 µm respirator until ≤ 50°C; (9) Reverse-rotation auto unloading through closed-system aseptic discharge port. Cantilever drum mounting (bearings outside tank) prevents wear-debris contamination. Inlet and outlet doors in different cleanroom grades with pneumatic interlock.
Prozessbeschreibung
1Stoppers/caps tumble in a slow-rotating wash drum (0.5–10 rpm VFD adjustable) inside a 135°C-rated wash tank (-0.1 to 0.25 MPa pressure).
2Process steps: (1) High-pressure spray + agitation pre-wash via central spray pipe + spiral guide vanes; (2) Gas-water mixed boiling rinse — bottom compressed-air injectors create bursting bubbles that micro-deform stoppers; (3) Ultrasonic + vacuum debubbling — bubbles in stopper crevices burst, allowing wash water in; (4) Self-circulating fine wash via Nanfang pump and inline filter; (5) Water sampling for QC; (6) WFI rinse; (7) Dry-heat sterilization (Fo ≥ 30 min adjustable) at 135°C with stainless heater coil + Class-100 HEPA hot-air circulation; (8) Cooling via Class-100 fresh air through 0.22 µm respirator until ≤ 50°C; (9) Reverse-rotation auto unloading through closed-system aseptic discharge port.
3Cantilever drum mounting (bearings outside tank) prevents wear-debris contamination.
4Inlet and outlet doors in different cleanroom grades with pneumatic interlock.
Technische Daten
Technische Daten für Variante: SED-2YX-R
Technische Daten
Modell
SED-2YX-R
Spannung
50Hz 380V 3-phase 5-wire
Versorgung
Three-phase 380V 50Hz 5-wire 8.5 kW; purified water ≥ 0.25 MPa, 130 kg/cycle; WFI ≥ 0.25 MPa, 150 kg/cycle; clean compressed air; Class-100 fresh air ~80 m³/cycle; drains DN65 / DN80 (304); WFI inlet DN38; PW inlet DN38
Konformitätsangaben
Inlet and outlet doors located in different cleanroom grades with pneumatic interlock to prevent cross-contamination. Tank wetted surfaces all radius-transition, no dead corners, no residue, mirror-polished Ra ≤ 0.4 µm. Sanitary-grade pipes inside-and-outside polished; argon-protected automatic welding. Utility requirements per cycle: purified water 130 kg @ ≥ 0.25 MPa; WFI 150 kg @ ≥ 0.25 MPa; Class-100 fresh air 80 m³.
Leistung
8.5 kW
Abmessungen
Länge
1800 mm
Breite
1500 mm
Höhe
2000 mm
Gewicht
2000 kg
Aufstellfläche
1800 × 1500 × 2000 mm (10,000-pc batch model). Larger batch sizes increase footprint.
Werkstoffe
Kontaktwerkstoffe
316L stainless steel (drum) mirror-polished Ra ≤ 0.4 µm; 304 stainless steel (tank, central spray, gas wash, breather, discharge spirals); PTFE (sanitary soft seal); cemented carbide (mechanical seal); chlorine-free aluminum silicate insulation
Gehäusewerkstoffe
304 stainless steel 1.5 mm shell; carbon steel channel frame; 304 stainless steel brushed exterior panels
Wesentliche Merkmale
4th generation, designed to 2010 GMP + EU cGMP + US FDA
Throughput 20,000 pcs/shift; 1–1.5 hour cycle
Handles rubber stoppers, lyo stoppers, aluminum caps and composite caps
Combined cleaning: high-pressure spray + air-water boiling rinse + ultrasonic + self-circulating fine wash + WFI rinse
Dry-heat sterilization Fo ≥ 30 min adjustable, 135°C tank design temperature
Hot-air assist drying via Class-100 HEPA + stainless heater coil at 120°C
Cooling via Class-100 fresh air through 0.22 µm respirator to ≤ 50°C
Reverse-rotation spiral discharge; sealed aseptic port option
Cantilever drum support — bearings outside tank prevent wear-debris contamination
Drum: 316L stainless steel, deburred punched holes, mirror-polished Ra ≤ 0.4 µm
Tank: design pressure -0.1 to 0.25 MPa; chlorine-free aluminum silicate insulation 50 mm
30–35% drum loading rate
All process valves changed from solenoid to pneumatic diaphragm (lower noise, longer life)
Inlet and outlet doors in different cleanrooms with pneumatic interlock (anti-cross-contamination)
Optional Class-100 isolator at outlet with FFU + glove ports + air-quality monitoring
Vacuum or manual feeding; spring-return self-aligning feed door (anti-spill)
PLC + colour LCD touchscreen with 3-tier password rights, electronic signature and electronic record (21 CFR Part 11 alignment)
Independent CIP/SIP — 4 swappable 360° wash balls inside tank
Cylinder dimensions Ø600 × 800 mm (drum); Ø870 × 1000 mm (tank)
Power 8.5 kW, 50 Hz 380V 3-phase 5-wire; weight ~2000 kg
Five-step cleaning + sterilize + dry + cool + discharge in one closed cycle
Cantilever drum design eliminates wear-particle contamination from bearings
Designed and built to GMP + cGMP + FDA — operating in 30 Chinese provinces and exported abroad
Optional Class-100 outlet isolator for true aseptic discharge
Siemens PLC + HMI with electronic-signature 21 CFR Part 11 alignment
All sanitary-grade polished pipes; argon-protected automatic welding throughout
Anwendungen
Cleaning and sterilizing rubber stoppers and aluminum caps for powder injectables
Cleaning lyo stoppers for lyophilized injectables
Cleaning stoppers for water-injection ampoules, oral solution, and large-volume infusion bottles
Pharmaceutical primary-packaging component preparation under GMP
Branchen
Pharmaceutical (injectable, lyophilized, oral solution, large-volume infusion)
Sterile primary packaging component cleaning
Komponentenhersteller
PLC + colour LCD HMI: Siemens 6AV6 643-OCD01-1AX1 (Germany)
Programmable module: Siemens 6ES7 221-1BF22-0XA8 (Germany)
PLC expansion: Siemens 6ES7 222-1HF22-0XA8 (Germany)
Bus connector: Siemens 6ES7 972-0BA12-0XA0 (Germany)
Relay LY2NJ ×27: Siemens (Germany)
AC contactor 3TB4142 ×3: Schneider (France)
VFD: Delta (Taiwan)
Cycloidal reducer XWY5-87-0.75: Zibo Reducer Plant (China)
Booster water pump MHI40-4-1/E/3-400-50: Nanfang CNP (China)
Air triplet AFC3000: Taiwan
Steam trap CS19W sanitary: Sino-foreign Shanghai JV (China)
Mechanical seal — acid/alkali-resistant cemented carbide: Wenzhou Mechanical Seal (China)
SED
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Konformität
GMP (China 2010)
EU cGMP
US FDA
21 CFR Part 11 alignment (electronic signature + electronic record + 3-tier password)
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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