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SED-1YX-Z
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SED-1YX-Z
SED · SED-1YX-Z · Destacado

SED-1YX-Z — Rubber Stopper Washing / Sterilizing / Drying Machine

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Rubber stopper washing/sterilizing/drying machine. Features pure-steam sterilization, vacuum degassing, vacuum drying, and hot-air drying — all in a closed chamber. Designed for the new GMP (China) requirement of feeding

GMP (new version, China)Compliant with new-version GMP cleaning process requirements
Plazo de entrega
Consultar
Capacidad de producción
10000 pcs/batch

Funcionamiento

Process: feeding → coarse wash (powerful spray + stirring) → air-water mixed boiling rinse → vacuum degassing rinse → fine wash (self-circulating) → rinse with sampling → pure-steam sterilization (121°C, F0 value time-controllable) → vacuum drying → hot-air drying → vacuum cooling → discharge. Combines slow drum tumbling with high-pressure compressed air and boiling water; vacuum degassing forces water into stopper crevices; saturated pure steam penetrates and sterilizes; vacuum + hot air dries; pulsed vacuum cools to ≤60°C before reverse-spiral discharge.

Proceso de funcionamiento
1Process: feeding → coarse wash (powerful spray + stirring) → air-water mixed boiling rinse → vacuum degassing rinse → fine wash (self-circulating) → rinse with sampling → pure-steam sterilization (121°C, F0 value time-controllable) → vacuum drying → hot-air drying → vacuum cooling → discharge.
2Combines slow drum tumbling with high-pressure compressed air and boiling water; vacuum degassing forces water into stopper crevices; saturated pure steam penetrates and sterilizes; vacuum + hot air dries; pulsed vacuum cools to ≤60°C before reverse-spiral discharge.

Especificaciones técnicas

Especificaciones de la variante: SED-1YX-Z

Especificaciones

Modelo
SED-1YX-Z
Capacidad de producción
10000 pcs/batch
Tensión
380V
Suministros
380V power (40 kW); purified water 1500 kg; water for injection 700 kg; pure steam 0.25 MPa ~90 kg; compressed air 0.6-0.8 MPa 1.2 m3; vacuum <-0.095 MPa
Potencia
40 kW
Presión de aire
0.6-0.8MPa, 1.2m³

Dimensiones

Longitud
2700 mm
Anchura
1850 mm
Altura
2500 mm
Peso
3000 kg

Materiales

Materiales en contacto
316 stainless steel (cleaning tank); 316L stainless steel (cleaning drum); PTFE; medical-grade silicone rubber; chlorine-free aluminum silicate insulation
Materiales del cuerpo
High-quality carbon steel welded frame; SS304 brushed plate (housing/insulation cover); 50mm chlorine-free aluminum silicate rock wool insulation

Características principales

Compliant with new GMP requirements
Novel center water-curtain spray technology (laser-cut narrow water-curtain slots)
Self-developed visible aseptic discharge system with sight glass
Closed discharge system with CIP and SIP capability
Fixed elephant-trunk discharge — no rotational friction particles
Cleaning drum external drive — drive system outside chamber to avoid metal-particle contamination
Drum and rear cover slide out together on built-in rails for cleaning/maintenance
Self-circulating water with 2-stage filter, level switch, low/high alarms
Double-seal: high-precision mechanical seal + sanitary soft flexible seal
Active condensate / low-temp steam auto-discharge (replaces steam trap) — temperature fluctuation ≤±0.5°C
Dual temperature probe + new pressure transmitter at coldest point (drain)
F0 value calculated every 6 seconds (vs. legacy 60s)
All actuators carry physical position feedback signal
Touchscreen discharge control on Class A side
Variable frequency drum 0.5-8 rpm; different rpm per stage (wash/sterilize/dry/cool)
Drum loading rate 30-35%
Tank design pressure -0.1 to 0.25MPa, design temperature ≥150°C
Empty heat distribution ≤±1°C; full-load heat penetration ≤±1°C
0.22µm SIP-rated air filter on breather
Pneumatic interlock between feed and discharge doors (different cleanliness zones)
Inlet/outlet doors physically interlocked — never open simultaneously
Safety valve opens at 0.16MPa over-pressure
Spring-return auto inlet door — prevents stoppers falling into tank
Inflatable seal ring auto-sealing on discharge port
4 retractable spray balls for 360° in-line cleaning
Three-level password authority (operator / process supervisor / system admin)
PDF report export per batch
Up to 50 recipe storage with parameter export/import
Real-time and historical alarm querying
Process aligns with new GMP cleaning requirements (vacuum degassing + air-water boiling + stopper transposition)
Coldest-point temperature sensor at drain ensures accurate F0 calculation
Online cleaning (CIP) and online sterilization (SIP)
Discharge port standard-designed for aseptic transport docking
Optional Class A protective isolator with FFU + glove ports at discharge
Air cooling option for vessels >160k stoppers
Saves water through self-circulation

Aplicaciones

Pharmaceutical rubber stopper cleaning
Aluminum cap cleaning
Antibiotic powder & water injection production
Sterilization of injectable components

Sectores

Pharmaceutical injectable manufacturing
Aseptic processing

Marcas de componentes

PLC and HMI touchscreen
Siemens
Pneumatic triplet, fittings, tee, piping
Taiwan-made (AirTAC equivalent)
Compressed air filter
Millipore
Valves
Hebron
Water pump (fine wash)
Imported German pump
Vacuum pump
Liquid ring vacuum pump (premium)
Cleaning tank
316 stainless steel
Cleaning drum
316L stainless steel
Mechanical seal
Acid/alkali-resistant alloy + PTFE
SED
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Conformidad

GMP (new version, China)
Compliant with new-version GMP cleaning process requirements

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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