SED-1.5MM-J
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SED-1.5MM-J
SED · SED-1.5MM-J · Destacado
SED-1.5MM-J — Pulsating Vacuum Sterilizer
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SED-1.5MM-J is a horizontal pulsating-vacuum saturated-steam sterilizer with a 1820 × 750 × 1100 mm inner chamber (1.5 m³) and motorized double-leaf doors with pneumatic sealing. Designed and built to GMP standards, it s
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Funcionamiento
Saturated steam is the sterilization medium; condensing steam releases latent heat and moisture causing microbial protein to coagulate and die. Cycle: automatic utility self-check → pulsed pre-vacuum (repeated vacuum + steam pulses to displace air) → heat-up to 132–134 °C → sterilization hold → exhaust → drying → end. The PLC monitors chamber temperature, pressure and vacuum in real time; the HMI logs every sterilization run for GMP traceability.
Proceso de funcionamiento
1Saturated steam is the sterilization medium; condensing steam releases latent heat and moisture causing microbial protein to coagulate and die.
2Cycle: automatic utility self-check → pulsed pre-vacuum (repeated vacuum + steam pulses to displace air) → heat-up to 132–134 °C → sterilization hold → exhaust → drying → end.
3The PLC monitors chamber temperature, pressure and vacuum in real time; the HMI logs every sterilization run for GMP traceability.
Especificaciones técnicas
Especificaciones de la variante: SED-1 .5MM-J: 1820 × 750 × 1100 mm chamber
Especificaciones
Modelo
SED-1.5MM-J
Tensión
AC380V three-phase 5-wire, 50Hz
Suministros
Drinking water: 0.1–0.3 MPa, ~350 kg/cycle. Steam: 0.4–0.6 MPa, ~60 kg/cycle. Compressed air: 0.5–0.7 MPa for door seal and pneumatic valves. Power: AC 380 V three-phase 5-wire 50 Hz, 4.5 kW.
Detalles de conformidad
Inner chamber 6 mm 316L SS; jacket 6 mm 304 SS. Door panel 8 mm 316L SS. Class I pressure vessel built to GB150.1/2/3/4-2011 with X-ray inspection and full quality records from labor bureau. GMP verification interface for IQ/OQ/PQ. Safety interlocks: double-door mechanical interlock, pressure-safety interlock, and door-seal pressure interlock. Includes 13% VAT in quoted price.
Potencia
4.5 kW
Presión de aire
0.5-0.7 MPa compressed air
Dimensiones
Longitud
2100 mm
Anchura
1480 mm
Altura
2000 mm
Peso
1900 kg
Superficie de instalación
External 2100 (L) × 1480 (W) × 2000 (H) mm. Pass-through double-door installation with operating side and sterile side on opposite walls.
Materiales
Materiales en contacto
316L stainless steel inner chamber (6 mm) and door panel (8 mm); 304 stainless steel sanitary clamp piping; medical-grade silicone rubber door seal; 304 stainless steel sterilization cars and trolleys.
Materiales del cuerpo
304 stainless steel jacket (6 mm); 304 stainless steel oil-grind drawn outer cover (1.2 mm); 50 mm aluminum silicate insulation.
Características principales
1820 × 750 × 1100 mm chamber (1.5 m³ nominal)
Inner liner 6 mm 316L stainless steel; outer jacket 6 mm 304 stainless steel
Double-leaf motorized doors with double-door interlock and pressure-safety interlock; door panel 8 mm 316L SS
Pneumatic angle-seat valves (ASCO USA), stainless steel valve body, 4-million-cycle service life
Water-ring vacuum pump (Shanghai Yulong): balanced operation, low noise, high vacuum
Circulating water pump: Germany WILO, reliable performance and long service life
Plate heat exchanger (Huisituo): high thermal efficiency, interchangeable plates, easy cleaning
0.22 µm air filter (Shantong Seiko) on steam inlet
Siemens S7 PLC (50 000-hour MTBF); PingTong touchscreen HMI; Beijing Weihuang micro-printer (EPSON head)
Thermal uniformity ≤ ±1 °C; ultimate vacuum −0.095 MPa
Pt100 Class-A temperature probes (Iris, error ≤ 0.15 °C); HUBA pressure transmitter (Switzerland)
Paperless data recorder for real-time sterilization temperature logging
GMP-validated saturated-steam sterilization with full pressure-vessel certification
Thermal uniformity ±1 °C across 1.5 m³ chamber
Double-door pass-through design separates non-sterile and sterile sides
Complete brand-name component bill: ASCO, WILO, Siemens, HUBA, EPSON
Class I pressure vessel built to GB150.1/2/3/4-2011 with X-ray inspection
HMI supports electronic signature and administrator role management for 21 CFR Part 11 alignment
Aplicaciones
Sterilization of garments and dressings
Sterilization of metal surgical and laboratory instruments
Sterilization of culture media and glassware
Pharmaceutical and hospital sterile-area pass-through sterilization
Sectores
Fabricación farmacéutica
Hospitals and clinics
Public health / CSSD
Scientific research / laboratories
Marcas de componentes
PLC: Siemens S7 (Germany)
Touch screen HMI: PingTong (Taiwan)
Micro printer: Beijing Weihuang (EPSON head)
Pneumatic angle-seat valves: ASCO (USA)
Solenoid valves: Airtac (Taiwan)
Water-ring vacuum pump: Shanghai Yulong
Circulating water pump: WILO (Germany)
Plate heat exchanger: Huisituo
Pressure gauge: Beijing Brady
Safety valve: Zhejiang Guangyi
Pressure transmitter: HUBA (Switzerland)
Temperature probes: Iris (Pt100 Class A)
Air filter: Shantong Seiko (0.22 µm)
SED
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Conformidad
GMP-compliant design with IQ/OQ/PQ verification interface
GB150.1/2/3/4-2011 steel pressure vessel standard
Class I pressure vessel
X-ray flaw inspected with quality certificate from labor bureau
Limpieza y mantenimiento
Sterilization chamber surface is precision-machined and chemically polished. Sanitary clamp piping in 304 SS allows tool-free disassembly for cleaning between batches. Decorative outer cover (1.2 mm 304 SS oil-grind finish) wipes clean with damp cloth. Sterilization cars and trolleys are 304 SS and can be hosed down.
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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