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Início / Equipamentos / Câmara de estabilidade de medicamentos / Pharmaceutical Stability Test Chamber (500 L) — YPX-S Series
SED-500YPX-S
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SED-500YPX-S YPX-S Series
SED · SED-500YPX-S · 1 unidades vendidas

SED-500YPX-S — YPX-S Series

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SED-500YPX-S Pharmaceutical Stability Test Chamber (500 L). Constant-temperature constant-humidity chamber for ICH-Q1A(R2)/Q1B and 2020 Chinese Pharmacopoeia stability testing — long-term, accelerated, intermediate, phot

Compliant with JJF1101-2019 environmental test equipment temperature/humidity calibration specificationCompliant with 2020 China Pharmacopoeia drug stability testing guidelinesCompliant with ICH 2003 Q1A(R2) and Q1B
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Como funciona

Forced air circulation balanced temperature/humidity control. Centrifugal fan circulates air through duct containing heater, evaporator, humidifier and dehumidifier sections; conditioned air enters chamber uniformly. Heating: nickel-chromium electric element with PID control via SSR (solid-state relay, zero-cross firing). Refrigeration: imported fully-sealed compressor with R134a (DuPont). Humidification: built-in electric steam (water from internal pump, closed-loop). Dehumidification: refrigeration coil. Temperature sensor: PT100 Class A (Yifan/Taiwan); humidity sensor: Vaisala Y60 (Finland).

Processo de funcionamento
1Forced air circulation balanced temperature/humidity control.
2Centrifugal fan circulates air through duct containing heater, evaporator, humidifier and dehumidifier sections; conditioned air enters chamber uniformly.
3Heating: nickel-chromium electric element with PID control via SSR (solid-state relay, zero-cross firing).
4Refrigeration: imported fully-sealed compressor with R134a (DuPont).
5Humidification: built-in electric steam (water from internal pump, closed-loop).
6Dehumidification: refrigeration coil.
7Temperature sensor: PT100 Class A (Yifan/Taiwan); humidity sensor: Vaisala Y60 (Finland).

Especificações técnicas

Especificações da variante: SED-150YPX-S 150 L

Especificações

Modelo
SED-500YPX-S
Tensão
AC 220V / 50Hz (single phase typical for this size)
Utilidades
Electrical: AC 220 V/50 Hz, 3 kW rated maximum. Water: deionized water supply for internal humidification reservoir (auto-fed via small internal pump). Drain not strictly required — closed water loop.
Detalhes de conformidade
12-month warranty after customer acceptance with 24-hour response, 2-day on-site arrival, 3-day fix SLA. Lifetime maintenance after warranty (parts at cost). Full 3Q validation file (DQ/IQ/OQ + FAT/SAT/PQ) included on USB. Compliant with Chinese GMP drug manufacture quality management regulations.
Potência
3 kW

Dimensões

Comprimento
1020 mm
Largura
1100 mm
Altura
1720 mm
Área de instalação
Floor-standing on 4 lockable casters. External dimensions 1020×1100×1720 mm (W×D×H). Allow rear and side clearance for ventilation and door swing.

Materiais

Materiais de contato
Mirror-finish stainless-steel inner liner
Materiais do corpo
Cold-rolled steel outer cabinet, phosphated and electrostatically powder-coated; polyurethane foam insulation (water-resistant, environmentally friendly); high-temperature silicone-rubber door gasket

Características principais

Volume: 500 L (internal W×D×H = 800×700×900 mm)
Temperature range 10–65 °C; control fluctuation ±0.5 °C; deviation ±2.0 °C; uniformity 2.0 °C
Humidity range 20–98% RH; uniformity/deviation 5.0% RH
Optional photostability lighting 0–10,000 lx (deviation ±500 lx); near-UV 300–400 nm
Touchscreen PLC controller; resolution 0.1 °C / 0.1% RH; PID self-tuning
Three-tier permission (admin / operator / visitor) with audit-trail logging
Built-in 4 GB storage (~1 year data); USB export (~5 years)
Dot-matrix printer for time/temperature/RH/lux records
Vaisala (Finland) humidity sensor; Class-A PT100 temperature sensor
Imported fully-sealed compressor (R134a refrigerant)
Two adjustable shelves (≥10 kg load each)
Single door with lock + tempered-glass observation window + Phi 50 mm test port on left side
Four casters with brakes — movable
Independent over-temperature protection (separate sensor cuts heater)
Audible/visual alarm + SMS/app push for over-temp/RH, low water, compressor overload, power-loss
ICH/Pharmacopoeia-compliant stability chamber — required for GMP drug registration
Three-tier permission + audit trail required by data-integrity (ALCOA+) audits
Vaisala humidity sensor — gold standard in pharmaceutical stability testing
Full validation document set provided (DQ, IQ, OQ, PQ, FAT, SAT) on USB
12-month warranty with 24-hour response, 2-day on-site, 3-day fix commitment; lifetime maintenance after warranty
Optional SMS/mobile-app alarm for unattended overnight runs

Aplicações

ICH long-term stability test (25 °C/60% RH; 30 °C/65% RH; 5 °C; -20 °C)
Accelerated stability test (40 °C/75% RH for 6 months)
Intermediate stability test (30 °C/65% RH for 12 months)
Influencing-factor tests (high temp 40/50/60 °C, high RH 25 °C/90% RH, photostability 4500 lx ±500 lx with near-UV)

Setores

Pharmaceutical manufacturing and R&D
Biotechnology
Medical and life sciences research

Marcas dos componentes

Compressor: imported fully-sealed with DuPont R134a refrigerant
Temperature sensor: Yifan (Taiwan) Class-A PT100 armored sensor
Humidity sensor: Vaisala Y60 (Finland)
Controller: touchscreen PLC with PID self-tuning
Contactor / breaker / relays: Schneider
SSR: solid-state relay (zero-cross power control)
Printer: dot-matrix microprinter
Casters: four movable casters with brakes
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Conformidade

Compliant with JJF1101-2019 environmental test equipment temperature/humidity calibration specification
Compliant with 2020 China Pharmacopoeia drug stability testing guidelines
Compliant with ICH 2003 Q1A(R2) and Q1B

Limpeza e manutenção

Mirror stainless-steel interior wipes clean. High-temperature silicone door gasket maintenance per schedule. Refill humidifier water reservoir with deionized (DI) water periodically via internal pump.

Documentação

Ficha técnica (PDF)
Visão geral do equipamento, especificações e dimensões · Documento original (inglês)
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Manual do operador
Instalação, operação e diagnóstico · Documento original (inglês)
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Folha comparativa (Padrão e Econômica)
Comparação das configurações · Documento original (inglês)
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Protocolos IQ / OQ / PQ
Documentação de validação para conformidade GMP · Documento original (inglês)
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Protocolos FAT / SAT
Testes de aceitação na fábrica e no local · Documento original (inglês)
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Desenhos CAD (STEP / IGES / DWG)
Desenhos de engenharia para a instalação · Documento original (inglês)
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Certificados de calibração
Nível sonoro, resistência de terra, rigidez dielétrica e rugosidade · Documento original (inglês)
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DQ (qualificação do projeto)
Protocolo completo de qualificação do projeto · Documento original (inglês)
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Certificados de materiais
Composição do aço inoxidável 316L · Documento original (inglês)
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