SED-0.6CM-J
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SED · SED-0.6CM-J · 1 unidades vendidas
SED-0.6CM-J — 0.6 m³, Double-Door Motorized
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SED-0.6CM-J 0.6 m³ horizontal pure-steam sterilizer (autoclave), designed for biopharmaceutical sterile-product manufacturing requiring zero-pyrogen sterilization media. Inner chamber 1,050 × 680 × 850 mm, 6 mm 316L sani
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Funcionamiento
Pure-steam pulsating-vacuum sterilization cycle. (1) Load onto 304 SS cart and roll into 316L chamber; both motorized doors close and interlock. (2) Preheat: steam to jacket warms chamber and load to minimize condensate. (3) Pulsating vacuum: water-ring pump alternates vacuum and steam injection to expel residual cold air and ensure uniform penetration of pure steam. (4) Heat-up: chamber temperature rises to 134°C / 0.22 MPa. (5) Sterilization: PLC holds setpoint for programmed time; F0 calculated in real time. (6) Drying: vacuum extraction plus jacket heat dries the load; make-up air enters via 0.22 μm sterile filter. (7) End: alarm; door unlocks; load removed.
Proceso de funcionamiento
1Pure-steam pulsating-vacuum sterilization cycle.
2(1) Load onto 304 SS cart and roll into 316L chamber; both motorized doors close and interlock.
3(2) Preheat: steam to jacket warms chamber and load to minimize condensate.
4(3) Pulsating vacuum: water-ring pump alternates vacuum and steam injection to expel residual cold air and ensure uniform penetration of pure steam.
5(4) Heat-up: chamber temperature rises to 134°C / 0.22 MPa.
6(5) Sterilization: PLC holds setpoint for programmed time; F0 calculated in real time.
7(6) Drying: vacuum extraction plus jacket heat dries the load; make-up air enters via 0.22 μm sterile filter.
8(7) End: alarm; door unlocks; load removed.
Especificaciones técnicas
Especificaciones de la variante: SED-0 this model
Especificaciones
Modelo
SED-0.6CM-J
Tensión
AC 380V 50Hz, 3-phase 5-wire (also 220V option per spec)
Suministros
Electricity: AC 380V / 50Hz / 3-phase 5-wire (220V option available), 2.5 kWh per cycle. Boiler steam 0.4–0.6 MPa to integrated 48 kW pure-steam generator. Drinking water + pure water 0.1–0.3 MPa (~200 L/cycle). Compressed air 0.5–0.7 MPa.
Detalles de conformidad
Designed and manufactured per GMP and GB150-2011; 100% X-ray weld inspection; pure-steam interior eliminates pyrogen carryover; double-door and pressure safety interlock.
Potencia
2.5 kW
Presión de aire
Chamber working 0.22 MPa; design 0.245 MPa; ultimate vacuum -0.095 MPa
Dimensiones
Longitud
1330 mm
Anchura
1400 mm
Altura
1920 mm
Peso
1200 kg
Superficie de instalación
Footprint approx. 1,330 × 1,400 mm, height 1,920 mm; net weight 1,200 kg. Reserve clearance for door swing, steam, water, compressed-air, and electrical connections.
Materiales
Materiales en contacto
6 mm 316L sanitary SS chamber; 316L sanitary pure-steam piping with quick-clamp fittings; medical silicone-rubber door seal; 304 SS loading cart, transport carts, and sieve plates.
Materiales del cuerpo
6 mm 304 SS jacket — 304 SS door panels — 50 mm aluminum-silicate insulation — 1.2 mm 304 oil-mill brushed SS decorative casing.
Características principales
Chamber 1,050 × 680 × 850 mm (0.6 m³), 6 mm 316L sanitary SS
Double-leaf motorized doors with safety interlock and compressed-air seal
Design 0.245 MPa / 139°C; working 0.22 MPa / 134°C; heat uniformity ≤±1°C; vacuum −0.095 MPa
Integrated 48 kW electric pure-steam generator — pure-steam grade (no pyrogen carryover)
Pulsating-vacuum air removal via Yulong water-ring vacuum pump
Siemens S7-200 PLC + TRE touchscreen + micro-printer with F0 reporting
ASCO USA angle-seat pneumatic valves (4 M cycle life)
GEMU Germany diaphragm valves
0.22 μm sterile air filter (Jiangsu Santong)
HUBA Switzerland pressure transmitter; Shenzhen Kexin Pt100 Class A
Includes loading cart × 1, transport carts × 2, sieve plate set
Per GMP and GB150-2011; 100% X-ray weld inspection
Pure-steam grade eliminates pyrogen carryover — meets highest biopharmaceutical GMP requirements
Integrated 48 kW steam generator — self-contained, no external steam supply needed
Double-door pass-through layout cleanly separates clean and dirty sides
Real-time F0 monitoring with printable sterilization report
Brand-name components: Siemens PLC, ASCO/GEMU valves, HUBA transmitter
GMP + GB150-2011 documented with X-ray weld inspection
Aplicaciones
Sterilization of sterile gowning for B/C cleanrooms
Sterilization of antibiotics and heat-stable APIs
Sterilization of injection rubber stoppers, aluminum caps, aluminum drums
Small-capacity unsealed liquid sterilization
Biopharmaceutical equipment and accessories terminal sterilization
Sectores
Biopharmaceutical manufacturing
Sterile injectable manufacturing
Vaccine manufacturing
Hospital central sterile services (high-end)
Clinical research / GMP pilot facilities
Marcas de componentes
Siemens Germany — S7-200 PLC
TRE Taiwan — touchscreen HMI
Beijing Weihuang — micro-printer with EPSON chip
ASCO USA — angle-seat pneumatic valves (4 M cycle life)
GEMU Germany — diaphragm valves
Yulong — water-ring vacuum pump
Jiangsu Santong — 0.22 μm sterile air filter
AirTAC Taiwan — solenoid valve
Rongcheng — steam trap
Beijing Brady — pressure gauge
Zhejiang Guangyi — safety valve
HUBA Switzerland — pressure transmitter
Shenzhen Kexin — Pt100 Class A temperature probes
SED
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Conformidad
Designed per GMP requirements
Manufactured to GB150-2011 steel pressure vessel standard
100% X-ray weld inspection with labor-bureau quality certificate
Limpieza y mantenimiento
Mirror-polished 316L chamber — clean with WFI/purified water and compatible alcohol per pharma SOP. Inspect medical silicone door seal each shift; replace per maintenance schedule. Verify 0.22 μm sterile air filter integrity periodically.
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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