SED-0.36CM-J
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SED-0.36CM-J
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
SED-0.36CM-J is a 0.36 m³ horizontal pure-steam sterilization cabinet with built-in 36 kW electric steam generator, double-leaf motorised doors with pharmaceutical-grade silicone compressed-air seal, and SUS316L inner li
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Como funciona
The built-in 36 kW electric steam generator produces pure (pyrogen-free) steam, which is admitted to the inner chamber as the sterilisation medium. Pulsating vacuum pre-conditioning removes residual cold air and ensures uniform steam penetration. During the holding period, saturated steam condenses on the load, releasing latent heat and coagulating microbial proteins. After sterilisation, vacuum suction-drying combined with jacket heat (ordinary boiler steam) dries and cools the load. All inner piping is 316L sanitary-grade to maintain GMP-compliant pure-steam quality.
Processo de funcionamento
1The built-in 36 kW electric steam generator produces pure (pyrogen-free) steam, which is admitted to the inner chamber as the sterilisation medium.
2Pulsating vacuum pre-conditioning removes residual cold air and ensures uniform steam penetration.
3During the holding period, saturated steam condenses on the load, releasing latent heat and coagulating microbial proteins.
4After sterilisation, vacuum suction-drying combined with jacket heat (ordinary boiler steam) dries and cools the load.
5All inner piping is 316L sanitary-grade to maintain GMP-compliant pure-steam quality.
Especificações técnicas
Especificações da variante: SED-0 0.36 m³ chamber (1
Especificações
Modelo
SED-0.36CM-J
Tensão
AC 380V three-phase five-wire, 50Hz (220V also indicated)
Utilidades
Boiler steam 0.4–0.6 MPa (jacket pre-heat, ~30 kg/cycle); water 0.1–0.3 MPa (~150 kg/cycle); compressed air 0.5–0.7 MPa; AC 380V three-phase five-wire 50 Hz, 36 kW (electric steam generator).
Detalhes de conformidade
Strict GMP design and manufacture per GB150-2011 Class I pressure vessel. X-ray flaw detection on every unit; complete labour-bureau quality documentation. SUS316L sanitary inner piping for pure-steam quality. Door safety interlocks meet pressure-vessel safety standard. Two-way temperature monitoring and storage for sterilisation batch records.
Potência
36 kW
Pressão de ar
Compressed air 0.5–0.7 MPa; steam 0.4–0.6 MPa; water 0.1–0.3 MPa
Dimensões
Comprimento
1270 mm
Largura
1320 mm
Altura
1800 mm
Peso
1000 kg
Área de instalação
Overall 1,270 × 1,320 × 1,800 mm (L×W×H); chamber 1,000 × 600 × 600 mm. Requires double-side door clearance for double-leaf motorised doors and trolley loading.
Materiais
Materiais de contato
SUS316L stainless steel (inner chamber, sanitary piping); pharmaceutical-grade silicone (door seal)
Materiais do corpo
SUS316L inner liner 6 mm / SUS304 jacket 6 mm / SUS304 door panel / SUS304 sieve plate / SUS304 loading and transport carts / SUS304 outer cover 1.2 mm / aluminium-silicate insulation 50 mm
Características principais
Chamber 1,000 × 600 × 600 mm (L×W×H), volume 0.36 m³
Built-in 36 kW electric pure-steam generator
Design pressure 0.245 MPa; design temperature 139 °C
Working pressure 0.22 MPa; working temperature 134 °C
Thermal uniformity ≤±1 °C; ultimate vacuum −0.095 MPa
Double-leaf motorised doors; two-leaf interlock and pressure safety interlock
Pharmaceutical-grade silicone door seal; compressed-air automatic sealing
Siemens S7-200 PLC + Taiwan TRE touch screen + EPSON-chip micro printer + paperless data recorder
Dual temperature probes (chamber space + container liquid)
Pneumatic valve + steam trap drain prevents backflow contamination (eliminates check-valve leak risk)
0.22 µm sterile air filter — no secondary contamination
316L sanitary clamp inner piping
50 mm aluminium-silicate insulation; 1.2 mm SUS304 oil-brushed outer cover
X-ray flaw inspected per GB150-2011
Inner liner 6 mm 316L SS; outer jacket 6 mm 304 SS
Overall dimensions 1,270 × 1,320 × 1,800 mm; net weight 1,000 kg
1 loading cart + 2 transport carts (304 SS)
Built-in 36 kW electric steam generator — no external pure-steam plant required
GB150-2011 Class I pressure vessel with X-ray flaw detection and full labour-bureau quality documentation
Premium imports: Siemens PLC, ASCO/Burkert pneumatic valves, GEMU diaphragm valves, HUBA pressure transmitter
Two transport carts + one loading cart for B/C clean-zone sterile-handling workflow
Electronic signature, multi-level operator privileges, English/Chinese bilingual HMI
Aplicações
Sterilisation of sterile gowns and clean-room textiles
Sterilisation of antibiotic vials and fill containers
Sterilisation of rubber stoppers, aluminium caps and aluminium drums
Small-volume unsealed liquid sterilisation
B/C clean-zone sterilisation workflows
Setores
Biopharmaceutical manufacturing
Sterile injectable and parenteral
Vaccine production
API and finished-dose pharmaceutical plants
Marcas dos componentes
Siemens (Germany) — S7-200 PLC (MTBF 50,000 h)
ASCO (USA) — angle-seat pneumatic valves (4 million cycle life)
Burkert / Baode (Germany) — angle-seat pneumatic valves
GEMU (Germany) — diaphragm valves
TRE (Taiwan) — touch screen HMI
Airtac (Taiwan) — solenoid valves
HUBA (Switzerland) — pressure transmitter (high precision, strong anti-interference)
Weihuang Beijing — micro printer (original EPSON chip)
Yulong — water-ring vacuum pump (low noise, high vacuum)
Brady Beijing — pressure gauges
Zhejiang Guangyi — safety valves
Rongcheng Zhuangfa — steam traps
Shenzhen Kexin — Pt100 temperature probes (accuracy class A, error ≤0.15 °C)
Jiangsu Santong — 0.22 µm air filters
SED
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Conformidade
GB150-2011 steel pressure vessel (Class I)
GMP design and manufacture
X-ray flaw inspected with full quality certification from labour department
Limpeza e manutenção
Inner chamber 316L and sanitary piping designed for clean-in-place; clamp connections allow disassembly. Outer cover SUS304 oil-brushed for easy wipe-down. No specific CIP cycle described in source.
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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