SED-1.0MM1-A (2)
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SED-1.0MM1-A (2)
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SED-1.0MM1-A (2) — Autoclave de vácuo pulsante
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Pure-steam pulsed-vacuum sterilizer model SED-1.0MM1-A, 1000 L chamber, double-door design (loading door in Class B zone, unloading door in Class A zone, mechanically interlocked so both doors cannot open simultaneously)
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Como funciona
Double-jacketed vessel: pure steam in inner chamber for sterilization, raw boiler steam in jacket for vacuum-exhaust and drying. PLC + HMI controls run pre-set cycles: Bowie & Dick test (134°C/15 min), vacuum-leak test, porous-load (cloth/tools) sterilization with initial pulsed vacuum + sterilization + vacuum drying, and culture-medium cycles. Three PT100 temperature probes (2 movable inside chamber + 1 fixed at drain) ensure temperature uniformity ≤±1°C. Safety device returns chamber to atmospheric pressure on controller failure to allow loading-door opening.
Processo de funcionamento
1Double-jacketed vessel: pure steam in inner chamber for sterilization, raw boiler steam in jacket for vacuum-exhaust and drying.
2PLC + HMI controls run pre-set cycles: Bowie & Dick test (134°C/15 min), vacuum-leak test, porous-load (cloth/tools) sterilization with initial pulsed vacuum + sterilization + vacuum drying, and culture-medium cycles.
3Three PT100 temperature probes (2 movable inside chamber + 1 fixed at drain) ensure temperature uniformity ≤±1°C.
4Safety device returns chamber to atmospheric pressure on controller failure to allow loading-door opening.
Especificações técnicas
Especificações da variante: SED-1 1000 L
Especificações
Modelo
SED-1.0MM1-A (2)
Tensão
Per customer's local requirement
Utilidades
Power: 3.0 kW (per customer voltage); Steam: 0.2-0.3 MPa, DN25 pipe, 60 kg/cycle; Tap water: 0.2-0.3 MPa, DN25 pipe, 300 kg/cycle; Compressed air: 0.6-0.8 MPa, ø6 mm pipe, 0.3 m³/cycle
Detalhes de conformidade
Pressure vessel designed per Chinese steel pressure vessel regulations with labor-ministry quality certifications. GMP confirmation access ports installed. Three-level access control on operator software.
Potência
3 kW
Pressão de ar
Compressed air supply 0.6-0.8 MPa, ø6 mm pipe, 0.3 m³/cycle
Dimensões
Comprimento
1506 mm
Largura
1510 mm
Altura
1950 mm
Área de instalação
1506 x 1510 x 1950 mm (L x W x H) overall (chamber 1260 x 750 x 1100 mm)
Materiais
Materiais de contato
SUS316L chamber; SUS316L pure-steam piping; SS316 loading cart; medical-grade silicone rubber sealing strip
Materiais do corpo
SUS304 outer jacket; SUS304 raw-steam piping; SS304 transport cart; aluminium silicate insulation
Características principais
1000 L chamber (1260 x 750 x 1100 mm L x W x H)
Double-door, mechanically interlocked: load in Class B, unload in Class A
Inner chamber SS316L (6 mm thick), X-ray inspected; outer jacket SS304
Two separate pipeline systems: pure steam (SS316L) for chamber, raw steam (SS304) for jacket
Working temperature 100-134°C, design pressure 0.245 MPa, work pressure 0.22 MPa
Temperature uniformity ≤ ±1°C across chamber
3x PT100 sensors (Class A precision, JUMO Germany) — 2 movable inside chamber + 1 fixed at drain
Aluminum-silicate insulation
Built-in 4 standard cycles: Bowie & Dick test, vacuum-leak test, porous-load (cloth/tools), culture-medium
Safety interlock returns chamber to atmospheric pressure if controller fails
GMP confirmation access ports built in
PLC + HMI + micro-printer + data logger control
Three-level password access (admin, engineer, operator)
Custom loading cart (SS316) + transport cart (SS304) included
Premium component sourcing: GEMU valves (4M-cycle life), JUMO PT100 (≤0.15°C), DANFOSS pressure transmitter, SIEMENS S7-300 PLC (50,000-hour MTBF)
Designed for biopharmaceutical aseptic / pyrogen-free requirements
Both vacuum exhaust and drying with one machine
Suitable for sterilizing uniforms, aluminium kegs for antibiotics, rubber stoppers
Aplicações
Pure steam sterilization of biotic-pharmaceutical materials
Sterilization of uniforms and gowns
Sterilization of aluminium kegs for antibiotics and rubber stoppers
Porous-load (cloth/tools) sterilization with pulsed vacuum
Bowie & Dick steam-penetration testing
Culture-medium substrate sterilization (per customer recipe)
Setores
Biopharmaceutical manufacturing
Sterile injectable production
Antibiotic packaging components
Marcas dos componentes
Body & doors: CINO (SS316L)
PLC: Siemens S7-300 (Germany)
Touchscreen HMI: Tianren (China) TP-700
Micro printer: Brightek (Beijing) WH series
PT100 temperature sensors: JUMO (Germany) Class A
Pressure transmitter: Danfoss (Denmark) MBS-1900
Pressure controller: Lugong (Japan) SNS series
Solenoid valves: AirTac 3V1-06
Pneumatic angle valves: GEMU (Germany) APL series — double-sealing, 4M-cycle life
Air filters: Santong (China) FA series — 0.2 μm
Pressure gauges: Brighty (Beijing) YTH-98ZK
Safety valves: Guangyi A28-16P (SS304)
Door interlocks: CoRon CLJ series
Sealing strip: RUNDE medical silicone rubber
SED
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Conformidade
Designed to GMP requirements with confirmation access ports
Pressure vessel built per Steel Pressure Vessel configuration with labor-ministry quality certificates
Limpeza e manutenção
Calorie-hoop interlinkage fast joints (sanitary clamps) on product-contact piping for easy disassembly, cleaning, and parts replacement. Long-flow pure steam and air-fill pipework design ensures clean energy delivery.
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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