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SED-7.5YX-Z
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SED-7.5YX-Z
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SED-7.5YX-Z — Automatic Rubber Stopper Washer
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SED-7.5YX-Z Automatic Rubber Stopper Washer is a fourth-generation pharmaceutical rubber stopper cleaning, siliconization, sterilization, and drying machine designed to fully meet the new GMP requirements (China 2010 GMP
Prazo de entrega
Consultar
Capacidade de produção
7.5 /
Como funciona
Stoppers tumble in a slowly rotating drum (0.5-8 rpm VFD) inside a sealed chamber. Mechanical motion combines with high-pressure water spray, intermittent compressed-air injection that creates boiling/bubble-collapse impacts, and vacuum degassing — together stripping contaminants from every stopper surface (including crevices and pin-holes). Self-circulating filtered water (two-stage filter) provides fine wash and rinsing to save WFI. Saturated pure steam at 121 ℃ is held for an F0-controlled period (recalculated every 6 s) for sterilization. Vacuum drying followed by 100-class hot-air drying removes residual moisture; vacuum-cycled cooling brings the load below 60 ℃. Reverse drum rotation discharges via a closed CIP/SIP-capable port with airbag seal and inter-locked dual doors separating the loading (D/C-grade) and discharge (A-grade) cleanrooms.
Processo de funcionamento
1Stoppers tumble in a slowly rotating drum (0.5-8 rpm VFD) inside a sealed chamber.
2Mechanical motion combines with high-pressure water spray, intermittent compressed-air injection that creates boiling/bubble-collapse impacts, and vacuum degassing — together stripping contaminants from every stopper surface (including crevices and pin-holes).
3Self-circulating filtered water (two-stage filter) provides fine wash and rinsing to save WFI.
4Saturated pure steam at 121 ℃ is held for an F0-controlled period (recalculated every 6 s) for sterilization.
5Vacuum drying followed by 100-class hot-air drying removes residual moisture; vacuum-cycled cooling brings the load below 60 ℃.
6Reverse drum rotation discharges via a closed CIP/SIP-capable port with airbag seal and inter-locked dual doors separating the loading (D/C-grade) and discharge (A-grade) cleanrooms.
Especificações técnicas
Especificações da variante: SED-7.5YX-Z
Especificações
Modelo
SED-7.5YX-Z
Capacidade de produção
7.5 /
Tensão
380V 50Hz 3Φ
Utilidades
Power: 380V 50Hz 3-phase, 56 kW; Purified water: ~2600 kg/batch; WFI: ~1300 kg/batch; Pure steam: 0.25 MPa, ~160 kg/batch; Compressed air: 0.6–0.8 MPa, 1.8 m³/batch; Incoming power cable: 4+PE×16 mm²; Control cable: 60+PE×1 mm²
Potência
56 kW
Pressão de ar
0.6-0.8 MPa
Dimensões
Comprimento
3300 mm
Largura
2300 mm
Altura
2600 mm
Peso
4500 kg
Materiais
Materiais de contato
SS316; SS316L (drum and product-contact surfaces, Ra ≤ 0.4 μm)
Materiais do corpo
SS304 (outer skin and jacket cover); carbon-steel frame (powder-coated); chloride-free aluminum-silicate wool insulation (50 mm)
Características principais
Compliant with 2010 GMP, EU cGMP, US FDA
Vacuum auto-feeding through top-mount feeder
Central water-curtain spray (laser-cut nozzles, frequency-controlled pump pressure)
Air-water mixed boiling rinse with bubble-collapse cleaning
Vacuum degassing for crevice and pin-hole cleaning
Self-circulating fine wash (two-stage filtration) saves WFI
Pure-steam sterilization at 121℃ with F0 recalculated every 6 seconds
Vacuum drying plus 100-class hot-air drying
Pulsed vacuum cooling to ≤60℃ before discharge
Fully-enclosed sterile discharge system with transparent sight glass and CIP/SIP
Fixed elephant-trunk discharge (no rotating wear, zero metallic-particle risk)
Double-shaft (front + rear) drum support, externally driven
Dual mechanical + PTFE flexible drum-shaft seals
Active condensate / low-temperature steam evacuation via PLC-controlled angle-seat valves (replaces traditional steam traps)
Cold-spot dual RTD probe + mid-chamber control RTD; ±0.5℃ heat-distribution control
Pressure transmitter for chamber pressure regulation
Position-feedback signal on every executive valve
Pneumatic and program inter-locked feed/discharge doors
Over-pressure dual safety (safety valve at 0.16 MPa)
Optional 100-class FFU isolator at discharge port for B-grade cleanroom integration
Drum and rear-head removable on rail trolley for full internal cleaning
Siemens S7-1200 PLC + 12" Siemens HMI (Chinese, English optional)
Four-level password management, electronic signature, audit trail
Recipe management (50+ recipes), USB data export, Brother thermal printer
Wireless heat-distribution / heat-penetration validation tooling
All product-contact surfaces SS316/316L Ra ≤ 0.4 μm, fully radiused, no dead legs
Fourth-generation product proven across 30+ provinces and exported abroad
Patented dual-shaft drum support eliminates support-roller friction contamination
Patented sterile discharge port couples directly with stopper transfer systems
F0 recalculated every 6 s instead of every 60 s — tighter sterilization control
Active condensate evacuation gives ±0.5℃ uniformity (better than steam-trap designs)
Audit trail upgraded to meet new GMP data-integrity requirements
Higher-grade configuration than peers (Siemens, Schneider, Grundfos, GEMU, Camozzi)
Aplicações
Rubber stopper washing for powder injectables
Rubber stopper washing for lyophilized powder injectables
Rubber stopper washing for water injections (small-volume parenterals)
Rubber stopper washing for oral liquids
Rubber stopper washing for large-volume parenterals (LVP)
Aluminum cap washing
Setores
Fabricação farmacêutica
Injectable drug production
Sterile API manufacturing
Marcas dos componentes
PLC (CPU 1214C, SM1223, SM1231)
Siemens S7-1200
HMI (12" main, 7" discharge)
Siemens / Kunlun-Tongtai
Circuit breakers, contactors, sockets
Siemens
Intermediate relays
Schneider
VFD, switching power supply, industrial switch
Delta
Pressure transmitter, PT100 RTD
Xun'er
Level switch
Omron
Pneumatic valves
Hebron
Pneumatic FRL units, filter regulators
KAIYUAN
Manual ball valve, manual sampling valve, horizontal steam trap, top breather
Wenzhou
Vertical steam trap
Zhongzhi Jinggong
Safety valve
Zhejiang Haiyi
Pressure-reducing valve
Zhejiang Yongjiu
Pure-steam pressure gauge
Bourdon
Booster water pump
GLOBAL
Vacuum pump
Feiyao
Liquid filter, compressed-air sterile breather
Cobetter
Mechanical seal
Zhejiang Lantian
Door inter-lock pneumatic cylinders
Camozzi
Diaphragm/angle-seat valves (preferred imported brand)
GEMU
Imported water pump (preferred)
Grundfos
Thermal printer
Brother
SED
Fale com SED Sales Team
Especialistas em equipamentos · contato pelo WhatsApp
Consulte o horário e a disponibilidade da equipe
Conformidade
China 2010 new-version GMP
EU cGMP
US FDA standards
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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