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SED-2.0MM-J
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SED-2.0MM-J
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SED-2.0MM-J — SED-2.0MM-J Pulsating Vacuum + Water-Bath Dual-Use Sterilizer

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SED-2.0MM-J Pulsating Vacuum + Water-Bath Dual-Use Sterilizer (with GMP validation/safety inspection interface). Horizontal pass-through autoclave with double-door (pneumatic motorised, gas-sealed, double-door interlocke

China GMP (2010 revision)China Pharmacopoeia 2020 editionGB/T 150.1–150.4-2011 pressure vesselsYY 0085.1-1992 Pulsating vacuum pressure steam sterilizerGB 18278.1-2015 industrial moist-heat sterilizationISO standard
Prazo de entrega
Consultar
Capacidade de produção
600 L (chamber 1340x1000x1500 mm)

Como funciona

Saturated-steam sterilization with pulsating-vacuum air removal. Horizontal double-jacketed chamber: jacket pre-heated by 0.3–0.5 MPa industrial steam, then alternating pulsed vacuum + pure steam (multiple cycles) removes residual cold air before sterilization hold. After hold, vacuum drying + jacket-heated drying removes moisture. Water-bath mode: clean steam + air mixed overpressure with water immersion/spray for liquid loads in sealed containers. Full GMP validation interface with Siemens MES data extraction port. Cycle: preparation → preheat → vacuum → heat-up → sterilization → drying → end.

Processo de funcionamento
1Saturated-steam sterilization with pulsating-vacuum air removal.
2Horizontal double-jacketed chamber: jacket pre-heated by 0.3–0.5 MPa industrial steam, then alternating pulsed vacuum + pure steam (multiple cycles) removes residual cold air before sterilization hold.
3After hold, vacuum drying + jacket-heated drying removes moisture.
4Water-bath mode: clean steam + air mixed overpressure with water immersion/spray for liquid loads in sealed containers.
5Full GMP validation interface with Siemens MES data extraction port.
6Cycle: preparation → preheat → vacuum → heat-up → sterilization → drying → end.

Especificações técnicas

Especificações da variante: SED-2.0MM-J

Especificações

Modelo
SED-2.0MM-J
Capacidade de produção
600 L (chamber 1340x1000x1500 mm)
Tensão
AC 380V 50Hz
Potência
4.5 kW
Pressão de ar
Compressed air 0.5-0.7 MPa (oil-free, water-free, dust-free); clean compressed air 0.2-0.3 MPa; pure steam 0.2-0.4 MPa; industrial steam 0.3-0.5 MPa (also stated 0.4-0.6 MPa); water 0.1-0.3 MPa

Dimensões

Comprimento
1640 mm
Largura
2060 mm
Altura
2200 mm
Peso
2300 kg

Materiais

Materiais de contato
316L stainless steel (inner chamber, door, instrument-side piping, internal safety valve, sterilizing carts); medical-grade silicone rubber (door gasket); medical/food-grade gaskets and O-rings
Materiais do corpo
304 stainless steel jacket (autogenous gas-shielded full weld); 304 SS outer decorative panels; aluminium-silicate fibre insulation 60 mm (chlorine-free, asbestos-free)

Características principais

Dual-use: pulsating-vacuum (steam) + water-bath sterilization in one machine
Pass-through double-door (motorised, gas-seal, interlocked) with pressure safety interlock
Pulsating vacuum air removal + vacuum drying + jacket-heated drying
316L SS inner chamber with chamfered/radius corners (no dead angles); 304 SS jacket (full autogenous weld)
ASCO (USA) angle-seat pneumatic valves rated 4M cycles (clamp connection, PTFE seal, 184°C steam rated)
Siemens S7 PLC (50,000 h MTBF) + touch screen + micro-printer (Epson chip) + paperless recorder
Swiss HUBA pressure transmitter + AIRIS Pt100 A-grade sensors (error ≤0.15°C)
Vacuum leak test: evacuate to −90 kPa, pump off 10 min, leakage ≤1.3 kPa
Sterilization time 0–600 min adjustable; temperature uniformity ≤±1°C
MES/network interface (Siemens extraction port) for data connectivity
Dual-use pulsating-vacuum + water-bath capability in a single pass-through autoclave
Imported precision components: Siemens PLC, ASCO valves, HUBA pressure transmitter, AIRIS temperature probes
Designed per Chinese cGMP, GB/T 150 pressure vessel, YY 0085.1, GB 18278.1, ISO and CE
GMP validation interface with DQ/IQ/OQ/PQ documentation support
Network/MES interface (Siemens extraction) for real-time data archiving

Aplicações

Sterilization of surgical instruments and metal tools
Sterilization of dressings and sterile garments / textiles
Liquid (culture media) sterilization
Glassware sterilization
Bowie & Dick steam-penetration test
GMP validation runs (IQ/OQ/PQ)

Setores

Hospitals
Fabricação farmacêutica
Veterinary drug manufacturing (per GMP 2020 vet)
Scientific / experimental animal research

Marcas dos componentes

Angle-seat pneumatic valve (clamp, PTFE, 4M cycles, 184°C rated)
ASCO
Water-ring vacuum pump (direct-coupled, mechanical seal, low noise)
Yulong
Circulation pump
WILO
Plate heat exchanger
Huisituo
Air filter (0.22 µm, sterile grade)
Jiangsu Santong
Solenoid valve
AirTAC
Steam trap
CIS
Pressure gauge
Brady (Beijing)
Safety valve (0.1–0.3 MPa)
Guangyi (Zhejiang)
Spray nozzle (spiral, large flow, wide angle, non-clogging)
Sborun
PLC (S7 series, 50,000 h MTBF)
Siemens
Touch screen
TER
Micro printer (Epson chip, sterilization report + temp trend)
Weihuan (Beijing)
Paperless recorder
Unspecified
Pressure transmitter (high precision, anti-interference)
HUBA
Temperature probe (Pt100, A-grade, ≤0.15°C error)
AIRIS (Airuisi)
Sterilizing carts (316L SS, 2 units)
SED
Transport carts (304 SS, 2 units)
SED
SED
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Conformidade

China GMP (2010 revision)
China Pharmacopoeia 2020 edition
GB/T 150.1–150.4-2011 pressure vessels
YY 0085.1-1992 Pulsating vacuum pressure steam sterilizer
GB 18278.1-2015 industrial moist-heat sterilization
ISO standard
CE standard
GB 50447-2008, GB 14952-2010 (animal research facility)
GMP validation interface (DQ/IQ/OQ/PQ documentation)

Limpeza e manutenção

316L SS internal surfaces with chamfered corners and no dead angles for easy cleaning; silicone rubber door gasket cleaned with ordinary surface cleaning (no lubrication required)

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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