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SED-1.2GRM-J
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SED-1.2GRM-J
SED · SED-1.2GRM-J · Destacado

SED-1.2GRM-J — Armario de esterilización por calor seco

La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English

Class-100 dry-heat double-door sterilizer / depyrogenation oven SED-1.2GRM-J. Used in pharma for drying-sterilization of vials, ampoules, aluminium caps, solid materials, and for sterilization + depyrogenation of glasswa

Designed to GMP requirements with validation port for 12-point heat distribution testDoor seal certified for continuous 300°C operation
Plazo de entrega
Consultar
Capacidad de producción
Contáctenos

Funcionamiento

Long-shaft centrifugal fan circulates hot air through high-temperature HEPA filters into the working chamber via an adjustable convection wall (perforated micro-orifice panels) for laminar side-to-side cross-flow. Hot air absorbs moisture from the load, becomes humid, and is automatically expelled by a forced humidity-exhaust fan (with humid-resistant HEPA). After holding sterilization temperature, the heater shuts off and a forced cooling fan (1.1 kW) injects HEPA-filtered fresh air to cool the chamber rapidly to ≤40°C, at which point an audio/visual signal indicates cycle completion and the door can be opened. Side-supply / side-return planar laminar flow achieves Class-100 cleanliness within 30 min of fan startup.

Proceso de funcionamiento
1Long-shaft centrifugal fan circulates hot air through high-temperature HEPA filters into the working chamber via an adjustable convection wall (perforated micro-orifice panels) for laminar side-to-side cross-flow.
2Hot air absorbs moisture from the load, becomes humid, and is automatically expelled by a forced humidity-exhaust fan (with humid-resistant HEPA).
3After holding sterilization temperature, the heater shuts off and a forced cooling fan (1.1 kW) injects HEPA-filtered fresh air to cool the chamber rapidly to ≤40°C, at which point an audio/visual signal indicates cycle completion and the door can be opened.
4Side-supply / side-return planar laminar flow achieves Class-100 cleanliness within 30 min of fan startup.

Especificaciones técnicas

Especificaciones de la variante: SED-1.2GRM-J

Especificaciones

Modelo
SED-1.2GRM-J
Tensión
380V/220V, 50Hz, 3-phase AC
Suministros
Power: 380V/220V, 50Hz, 3-phase AC; total heating 27 kW + circulating fan 3 kW + cooling fan 1.1 kW + humidity-exhaust fan 1.1 kW + ancillaries; Compressed air for pneumatic door locking
Detalles de conformidad
Designed to meet pharmaceutical GMP requirements; validation port included on right side mid-chamber for 12-point temperature uniformity testing on installation. Door interlock prevents simultaneous open of clean and dirty side doors.
Potencia
27 kW

Dimensiones

Superficie de instalación
Not specified in source spec

Materiales

Materiales en contacto
316L stainless steel inner wall (2 mm); 316L convection wall (2 mm); 316L roof; 316 partition shelves (1.5 mm); high-temperature food-grade silicone rubber door seal
Materiales del cuerpo
304 stainless steel outer wall (2 mm); 304 acero inoxidable base (3 mm); 304 SS reinforcement angle (50x50x5 mm); aluminium silicate fibre cotton insulation (180 mm)

Características principales

Class-100 cleanliness inside chamber (achieved within 30 min of fan start-up)
Front-and-rear (pass-through) double doors with mechanical interlock — only one side can open at a time
U-shaped 380V/9 kW electric heating tubes (total 27 kW, infrared SS heating elements)
Long-shaft centrifugal circulating fan: 3 kW, 2100 m³/h, 1500 Pa, 10 m/s
Forced cooling fan 1.1 kW + HEPA — cools chamber rapidly post-cycle
Forced humidity-exhaust fan 1.1 kW with humidity-resistant HEPA
4 high-temperature HEPA filters (rated continuous 300°C operation) + side HEPA (700x900x150) + inlet/outlet HEPA (300x300x150)
Adjustable convection wall (SUS304 δ1.2 mm, perforated micro-orifices, tool-free quick-install for cleaning)
Empty heat distribution ±3°C
180 mm aluminium silicate fibre cotton insulation — outer surface ≤ ambient + 10°C
Pneumatic door locking (safer than mechanical lock)
Door seal: high-temperature food-grade silicone rubber (continuous 300°C)
Validation port on right side mid-chamber for 12-point temperature uniformity testing
Argon-arc-welded inner shell, all corners radius-curved, mirror-polished — no dead zones
PLC + touchscreen + temp/printer + chart recorder for full GMP traceability
Pre-configured cycle: drying -> heat-up -> sterilization -> cooling -> finish (all setpoints configurable up front)
GMP-validated Class-100 + depyrogenation in one unit
Pass-through double-door isolates clean and dirty zones
Premium components: Siemens PLC + HMI + VFD + breakers/contactors; CONROL solid-state relays; DWYER differential pressure
POSCO-grade SUS304/316L stainless construction
Validation-ready: temperature uniformity port for 12-point mapping included

Aplicaciones

Sterilization and depyrogenation of aluminium caps
Drying-sterilization of solid pharmaceutical materials
Sterilization and depyrogenation of glassware and metal-ware containers

Sectores

Pharmaceutical manufacturing (sterile injectable / parenteral)
Glass container preparation
Biopharmaceutical manufacturing

Marcas de componentes

Stainless plate: POSCO (Korean) — 304 outer 2.0 mm, 316L inner 2.0 mm, 304 base 3.0 mm, 316L convection wall 2.0 mm
PLC: Siemens S7-SMART
Touchscreen HMI: Siemens TP700
Circulating fan VFD: Siemens MM420
Contactors: Siemens 3TB41 / 3TB44
Breakers: Siemens 5SJ series (single-phase + high-breaking)
Solid-state relays: CONROL (USA)
Differential pressure gauge: Dwyer 0-500 Pa
Micro printer: Brightek (Beijing) WH-E361Z20
High-temp circulating fan: Y90L-2T 3 kW (Nanjing) <4900 m³/h
Door cylinders: in-house pneumatic
Heating tubes: Nanjing — U-shape 9 kW, 380V (3 in parallel for 27 kW)
Insulation: Changzhou aluminium silicate fibre cotton (180 mm)
HEPA filters: Changzhou (in/out 300x300x150 mm; side 700x900x150 mm)
Door seal: Nanjing (imported silicone rubber raw material)
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Conformidad

Designed to GMP requirements with validation port for 12-point heat distribution test
Door seal certified for continuous 300°C operation

Limpieza y mantenimiento

All inner corners radius-curved, mirror-polished, no dead zones. Convection wall uses tool-free quick-install design — can be removed and reinstalled by hand for cleaning.

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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