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SED-8YX-Z
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SED-8YX-Z
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SED-8YX-Z — Rubber Stopper Cleaning Machine

A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English

SED-8YX-Z (High-configuration) is a fully automatic rubber stopper / aluminium cap cleaning machine (Harbin Zhongyi Pharmaceutical Machinery Co., Ltd., Intelligent Management System V1.0). The complete cleaning cycle: lo

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Como funciona

Plugs/caps are loaded into the cleaning tank. The cycle alternates fill-rinse-drain stages with hot purified water or WFI, an air-water mixed turbulent rinse, and a vacuum de-foam pull (combines mechanical tumbling in the slowly rotating cleaning drum with high-pressure compressed air and boiling water jets; the vacuum de-foam step allows water to penetrate all surfaces of the stopper, while the soft collisions during tumbling break the bond between contamination and the stopper surface). After siliconization and fine rinse, pure steam (via SWEP plate heat exchanger) sterilizes the load at up to 120°C with continuous F0 calculation. Vacuum dry is followed by hot-air drying through a sterile breather filter and a cool-down stage. Full actuator and valve-position feedback is monitored on every process valve (spray, wall-spray, overflow, WFI inlet, purified-water inlet, circulating air, breather 1 and 2, compressed air, air-blast drain, lower main, circulating water, steam in, fresh air, blow-down, hot air, vacuum).

Processo de funcionamento
1Plugs/caps are loaded into the cleaning tank.
2The cycle alternates fill-rinse-drain stages with hot purified water or WFI, an air-water mixed turbulent rinse, and a vacuum de-foam pull (combines mechanical tumbling in the slowly rotating cleaning drum with high-pressure compressed air and boiling water jets; the vacuum de-foam step allows water to penetrate all surfaces of the stopper, while the soft collisions during tumbling break the bond between contamination and the stopper surface).
3After siliconization and fine rinse, pure steam (via SWEP plate heat exchanger) sterilizes the load at up to 120°C with continuous F0 calculation.
4Vacuum dry is followed by hot-air drying through a sterile breather filter and a cool-down stage.
5Full actuator and valve-position feedback is monitored on every process valve (spray, wall-spray, overflow, WFI inlet, purified-water inlet, circulating air, breather 1 and 2, compressed air, air-blast drain, lower main, circulating water, steam in, fresh air, blow-down, hot air, vacuum).

Especificações técnicas

Especificações da variante: SED-8YX-Z

Especificações

Modelo
SED-8YX-Z

Materiais

Materiais de contato
316L aço inoxidável
Materiais do corpo
304 aço inoxidável

Características principais

Full automated cycle: coarse wash → air-water mixed rinse → vacuum de-foam → siliconization → fine wash → steam sterilization → vacuum dry → hot-air dry → cool-down
Online sterilization, heat-resistant to 120°C
Water source switchable: purified water or water-for-injection (WFI)
Real-time F0 (sterility) value calculation
Recipe management with multi-formula recall
Vacuum leak-test mode with automatic report generation
Audit trail (operation records, work reports)
Real-time + historical alarms with fault query
Tank temperature monitoring 0–200°C; pressure monitoring −100 to +380 kPa
Compressed-air pressure monitoring 0–1,000 kPa
Full actuator/valve-position feedback on all process valves and door interlocks
SWEP plate heat exchanger for pure-steam heating
Central spray nozzle technology
Top-feed loading
Self-circulating system
Dual-seal combination technology
Automated end-to-end rubber-stopper / aluminium-cap prep ready for aseptic filling line
Sterilization with F0 calculation — pharmaceutical-grade SIP
Vacuum leak-test self-validation with auto report
Audit-ready data and alarm logging — GMP compliance
Compatible with both purified water and WFI

Aplicações

Rubber stopper cleaning + siliconization + sterilization
Aluminium cap cleaning + sterilization
Sterile-filling-line preparation (powder-for-injection, lyophilised powder, water-for-injection, oral liquid, large-volume infusion)

Setores

Pharmaceutical (sterile injectables)
Vaccine / biologics manufacturing

Marcas dos componentes

Siemens S7-1200 CPU 1214C (PLC — Germany)
Siemens SM1223 / SM1231 modules (I/O — Germany)
Siemens (HMI, air switches, sockets, breakers — Germany)
Schneider (intermediate relays — France)
Xun'er (pressure transmitter, PT100 — China)
Omron (liquid-level switch — Japan)
SWEP (plate heat exchanger)
Siemens (frequency inverter, switch power supply — Germany)
TaiDa (industrial switch — Taiwan)
Xiecheng Ultrasound (ultrasound module — China)
Wenzhou (manual ball valves, manual sample valves, horizontal strainers — China)
Xibo Lun (pneumatic valve gates — Germany/Europe)
Zhongzhi Jinggong (vertical strainers — China)
Zhejiang Haiyi (safety valve — China)
Zhejiang Yongjiu (pressure-reducing valve — China)
KAIYUAN (filter pressure-reducing valve, pneumatic FRL — China)
Braidish / Bleidish (pure steam pressure gauge — China)
GLOBAL (booster water pump — International)
Feiao (vacuum pump — China)
Hachong (reducer — China)
Kebute (liquid filter, compressed-air absorber — China)
Zhejiang Lantian (mechanical seal — China)
Hazhou (bearings — China)
Kangkena (discharge-door interlock seal, inlet-door interlock seal — China)
Brother (printer — Japan)
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Conformidade

GMP

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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