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Início / Equipamentos / Câmara de esterilização por banho de água / 13 m³ Double-Door Water-Shower Sterilizer (Autoclave)
SED-13SM-Q
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SED-13SM-Q
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SED-13SM-Q — 13 m³ Double-Door Water-Shower Sterilizer

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SED-13SM-Q 13 m³ Double Horizontal Sliding Door Water-Shower Sterilizer (Autoclave). Uses high-temperature circulating water as sterilizing medium delivered via spray. Closed circulating system controlled by external col

GMP inspection interface (supports IQ/OQ/PQ inspection programs)Pressure vessel quality certificate per autoclave industry criteria
Escolher variante (1)
Prazo de entrega
Consultar
Capacidade de produção
1008 soft bags/chamber/cycle

Como funciona

Auto-inspection (energy and equipment status) → water inlet → spray water and pure-water chamber circulation (chamber bottom → circulation pump → heat exchanger → upper spray system) → temperature rising (steam admitted to heat-exchanger channel) → sterilizing (dual temperature + F0 monitoring to setpoint) → cooling (cold water admitted to heat-exchanger channel) → water outlet (programmed) → finish.

Processo de funcionamento
1Auto-inspection (energy and equipment status) → water inlet → spray water and pure-water chamber circulation (chamber bottom → circulation pump → heat exchanger → upper spray system) → temperature rising (steam admitted to heat-exchanger channel) → sterilizing (dual temperature + F0 monitoring to setpoint) → cooling (cold water admitted to heat-exchanger channel) → water outlet (programmed) → finish.

Especificações técnicas

Especificações da variante: SED-13SM-Q 13 m³ double horizontal sliding-door water-shower sterilizer

Especificações

Modelo
SED-13SM-Q
Capacidade de produção
1008 soft bags/chamber/cycle
Utilidades
Steam supply (heat-exchanger heating side); cold water supply (cooling side); pure water for spray circulation (reused from chamber bottom reservoir); electrical for pumps, valves, PLC, and HMI; compressed air for pneumatic valves.
Detalhes de conformidade
Comprehensive safety interlocks per pharmaceutical autoclave safety standards. GMP-compliant IQ/OQ/PQ inspection programs including empty/full heat distribution (3 repeats each), heat penetration (3 repeats), and bio-indicator challenge.

Dimensões

Comprimento
4950 mm
Largura
4000 mm
Altura
2500 mm
Área de instalação
Chamber 2000 × Ø4350 mm. Overall machine envelope 4950 (L) × 4000 (W) × 2500 (H) mm. 13 m³ working volume.

Materiais

Materiais de contato
Chamber, plate-heat-exchanger sheets, spray system, and loading carts in 316L stainless steel; door seal in medical silicone rubber; flange in SS304.
Materiais do corpo
Chamber: 316L stainless steel (X-ray inspected); flange and external plates: SS304; whole stainless steel wire-drawn external skin.

Características principais

Horizontal cylindrical 316L stainless steel chamber for stability under repeated heat/cool cycles
Double horizontal sliding doors, cylinder-driven, with safety interlocks (no pressure with door open; door cannot open under pressure; door locked during cycle)
Efficient spiral spray / spray-board system for even heat distribution with no dead corners
Plate heat exchanger with 316 stainless steel plates
Cylinder bottom reservoir reuses pure chamber water — no separate water box
Calcium silicate insulation deck; whole stainless steel wire-drawn external plates
Standard GMP inspection interface (IQ/OQ/PQ programs)
Upper-machine + lower-machine control: PC monitors + Siemens PLC executes (MTBF >50,000 h)
Authority-tiered software: separate roles for operation, data query, parameter modification, program modification
Real-time pressure, temperature, time, F0 display; data and curve printout with backup
Remote computer monitoring
Designed pressure 0.35 MPa, temp 139°C; working 80–126°C
Heat distribution ≤±2°C, control precision ≤0.5°C
Sterilization time 70–99 min, programmable
13 m³ chamber capacity — loads up to 1008 soft IV bags per cycle
316L cylindrical body CO2-welded — long service life vs. rectangular vessels
Critical components imported (Danfoss pressure transmitter, JUMO Pt100 sensor, ASCO angle-seat valves, French circulation pump)
Comprehensive safety interlocks meet pharma autoclave safety standards
Built-in F0 management for terminal sterilization validation
GMP inspection interface supports IQ/OQ/PQ heat distribution and bio-indicator challenges
Suitable for soft IV bags, glass vials, ampoules, plastic bottles, beverage and food cans

Aplicações

Terminal sterilization of soft IV (LVP) bags
Liquid sterilization in glass vials and ampoules
Plastic-bottle liquid sterilization
Beverage bottle and food can sterilization
Pharmaceutical solution and suspension sterilization

Setores

Pharmaceutical manufacturing (LVP / parenteral / oral liquids)
Food and beverage processing
Health products / nutraceuticals

Marcas dos componentes

Chamber: VSUN, 316L stainless steel (X-ray inspected)
Flange and external sheet: VSUN, SS304
Door sealing: VSUN medical-grade silicone rubber
PLC: Siemens (MTBF >50,000 h)
HMI touchscreen: Siemens
Pressure transmitter: Danfoss
Temperature sensor: JUMO Pt100 (≤0.15°C equilibrium accuracy)
Computer: Lenovo (backstage monitoring + report storage)
Printer: HP (sterilization report output)
Angle pneumatic valves: ASCO (double sealing, 4 million-cycle life)
Plate heat exchanger: 316 stainless steel plates
Vacuum pump: D-STRING (high-temp, stainless pump head)
Spraying system: VSUN, 316L stainless steel
Safety valve: Guangyi (high sensitivity)
Solenoid / air reversing valves: E.MC
Loading cart: VSUN, 316L stainless steel
Circulation pump: French imported hot-water pump
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Conformidade

GMP inspection interface (supports IQ/OQ/PQ inspection programs)
Pressure vessel quality certificate per autoclave industry criteria

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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