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SED-2YX-R
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SED-2YX-R
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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
Plazo de entrega
Consultar
Capacidad de producción
Contáctenos
Funcionamiento
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.
Proceso de funcionamiento
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.
Especificaciones técnicas
Especificaciones de la variante: SED-2YX-R
Especificaciones
Modelo
SED-2YX-R
Tensión
50Hz 380V 3-phase 5-wire
Suministros
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
Detalles de conformidad
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.
Potencia
8.5 kW
Dimensiones
Longitud
1800 mm
Anchura
1500 mm
Altura
2000 mm
Peso
2000 kg
Superficie de instalación
1800 × 1500 × 2000 mm (10,000-pc batch model). Larger batch sizes increase footprint.
Materiales
Materiales en contacto
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
Materiales del cuerpo
304 stainless steel 1.5 mm shell; carbon steel channel frame; 304 stainless steel brushed exterior panels
Características principales
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
Aplicaciones
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
Sectores
Pharmaceutical (injectable, lyophilized, oral solution, large-volume infusion)
Sterile primary packaging component cleaning
Marcas de componentes
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
Hable con SED Sales Team
Especialistas en equipos · contacto por WhatsApp
Consulte el horario y la disponibilidad del equipo
Conformidad
GMP (China 2010)
EU cGMP
US FDA
21 CFR Part 11 alignment (electronic signature + electronic record + 3-tier password)
Documentación
Ficha técnica (PDF)
Resumen del equipo, especificaciones y dimensiones · Documento original (inglés)
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Manual del operador
Instalación, funcionamiento y diagnóstico · Documento original (inglés)
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Ficha comparativa (Estándar y Económica)
Comparación de configuraciones · Documento original (inglés)
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Protocolos IQ / OQ / PQ
Documentación de validación para conformidad GMP · Documento original (inglés)
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Protocolos FAT / SAT
Pruebas de aceptación en fábrica y en sitio · Documento original (inglés)
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Planos CAD (STEP / IGES / DWG)
Planos de ingeniería para la instalación · Documento original (inglés)
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Certificados de calibración
Nivel sonoro, resistencia de tierra, rigidez dieléctrica y rugosidad · Documento original (inglés)
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DQ (cualificación del diseño)
Protocolo completo de cualificación del diseño · Documento original (inglés)
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Certificados de materiales
Composición del acero inoxidable 316L · Documento original (inglés)
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