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SED-5000YPX-S
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SED-5000YPX-S
SED · SED-5000YPX-S · Destacado

SED-5000YPX-S — Walk-in Pharmaceutical Stability Test Chamber

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SED-5000YPX-S Walk-in Pharmaceutical Stability Test Chamber. Working chamber 1800×1500×2000 mm (D×W×H); external dimensions 2200×1700×2400 mm. Temperature range 10–65 °C, fluctuation ±0.5 °C, uniformity 2 °C, deviation ≤

Compliant with Chinese Pharmacopoeia 2020 standardMeets GMP/FDA/ICH Q1B accelerated/long-term/high-humidity test requirementsComplies with national standards for pollution and electromagnetic radiationIQ/OQ/PQ/DQ validation documentation providedPatrol device and probe certificates provided
Plazo de entrega
Consultar
Capacidad de producción
Contáctenos

Funcionamiento

Forced-air-circulation temperature-humidity balancing system: multiple EBM fans (Germany) force air through ducts; heating (nickel-chromium alloy heaters, SSR PID control), refrigeration/dehumidification (Tecumseh hermetic compressors, R134A), humidification (water-trough electric heating generating steam), and dehumidification (vapor-compression refrigeration) systems are all located in the duct and feed conditioned air uniformly into the working chamber. Vaisala HMP60 humidity sensor and Pt100 temperature sensor provide real-time feedback to the Reels TEMI1080 controller, which uses PID algorithms and SSR zero-crossing switching to maintain target temperature and humidity within specification.

Proceso de funcionamiento
1Forced-air-circulation temperature-humidity balancing system: multiple EBM fans (Germany) force air through ducts; heating (nickel-chromium alloy heaters, SSR PID control), refrigeration/dehumidification (Tecumseh hermetic compressors, R134A), humidification (water-trough electric heating generating steam), and dehumidification (vapor-compression refrigeration) systems are all located in the duct and feed conditioned air uniformly into the working chamber.
2Vaisala HMP60 humidity sensor and Pt100 temperature sensor provide real-time feedback to the Reels TEMI1080 controller, which uses PID algorithms and SSR zero-crossing switching to maintain target temperature and humidity within specification.

Especificaciones técnicas

Especificaciones de la variante: SED-5000YPX-S

Especificaciones

Modelo
SED-5000YPX-S
Tensión
AC380V 50Hz (max 7kW,run 3.5kW)
Detalles de conformidad
Temperature deviation ≤±1.5 °C; humidity deviation ≤±2 %RH; safety protections: reliable grounding, leakage/breaker protection, heater short-circuit protection, humidifier short-circuit protection, water cut/dry-burn protection, compressor overload/overheat protection, independent over-temperature protection (audible and visual alarm); operating environment 10–35 °C, ≤85 %RH; storage environment 10–35 °C; power supply AC380 V 50 Hz three-phase five-wire; 2-year warranty.
Potencia
7 kW

Dimensiones

Longitud
2200 mm
Anchura
1700 mm
Altura
2400 mm

Materiales

Materiales en contacto
316 stainless steel inner cabinet panel; 304 stainless steel air duct cabinet; SUS304 humidifier; A-class Pt100 platinum resistance sensor
Materiales del cuerpo
Color steel 1.0 mm exterior, white-grey paint coating; mirror SS inner cabinet 1.0 mm; 100 mm flame-retardant rigid polyurethane insulation; environmentally-friendly silicone door seal; double-glazed vacuum heated observation window; galvanized integrated 4-layer rack

Características principales

Walk-in chamber 1.8×1.5×2.0 m (D×W×H) — 5400 L volume
Temperature range 10–65 °C
Humidity range 20–95 %RH
Temperature fluctuation ±0.5 °C, uniformity 2 °C, deviation ≤±1.5 °C
Humidity fluctuation ≤±2.0 %RH, uniformity ≤±2.5 %RH
Heating rate 3 °C/min, cooling rate 1 °C/min
Installed 7 kW, running 3.5 kW, noise ≤60 dB
Vaisala HMP60 electronic humidity sensor (Finland)
A-class Pt100 platinum resistance temperature sensor (Shanghai Jiudu JM)
Reels TEMI1080 touch-screen controller (Canada)
Schneider electrical throughout (France)
Tecumseh hermetic compressors duty/standby (France)
DuPont R134A eco-friendly refrigerant (USA)
EBM fans (Germany), Kawamura capillary (Japan)
USB data export + real-time printing + curve and data recording
3-level password access + audit trail + system log
Optional wireless RS485 + SMS alarm
316 SS inner panel + 304 SS air duct cabinet
100 mm flame-retardant rigid polyurethane insulation
Silicone door seal + double-glazed vacuum heated observation window
Galvanized integrated 4-layer adjustable shelving
IQ/OQ/PQ/DQ validation documents included; on-site validation 4 sessions
2-year warranty (best in class)
Meets GMP/FDA/ICH Q1B/Chinese Pharmacopoeia 2020 stability test requirements
Provides IQ/OQ/PQ/DQ validation documentation + patrol device and probe certificates
4 on-site validation sessions: no-load, full-load, door open/power-off, software
Imported core components: Vaisala (Finland) + Schneider (France) + Tecumseh (France) + DuPont (USA) + EBM (Germany) + Kawamura (Japan)
3-level access + audit trail + SMS alarm meets data integrity requirements
316 SS inner panel for superior sealing
100 mm polyurethane insulation for energy efficiency
Duty/standby compressors for long-term trouble-free operation
2-year warranty (longest in the industry)

Aplicaciones

Pharmaceutical drug stability study
New drug accelerated testing
New drug long-term testing
High-humidity testing
ICH Q1B photostability testing
Health supplement stability

Sectores

Farmacéutico
New drug R&D
Health supplements
Food R&D
Laboratorio

Marcas de componentes

Humidity sensor HMP60
Vaisala
Temperature sensor PT100
JM (Shanghai Jiudu) / A-class Pt100
Temperature-humidity controller TEMI1080
Reels
Electrical (circuit breakers/contactors/relays)
Schneider
Hermetic compressors
Tecumseh / Copeland
Refrigerant R134A
DuPont
Fans
EBM
Capillary tube
Kawamura
Monitoring probes
EVE (optional)
SED
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Conformidad

Compliant with Chinese Pharmacopoeia 2020 standard
Meets GMP/FDA/ICH Q1B accelerated/long-term/high-humidity test requirements
Complies with national standards for pollution and electromagnetic radiation
IQ/OQ/PQ/DQ validation documentation provided
Patrol device and probe certificates provided

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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