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SED-1YX-K
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SED-1YX-K
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SED-1YX-K — Rubber Stopper Washing Machine
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
Fully automatic rubber stopper washing and drying machine (4th generation). Designed per China GMP, EU cGMP, and US FDA standards. Washing, rinsing, drying, and cooling all completed in a single closed chamber, eliminati
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Como funciona
Rubber stoppers are loaded via the inlet into the rotating cleaning drum. Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge. Entire process controlled by PLC; parameters preset via touchscreen. Three modes: automatic, semi-automatic, and manual.
Processo de funcionamento
1Rubber stoppers are loaded via the inlet into the rotating cleaning drum.
2Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge.
3Entire process controlled by PLC; parameters preset via touchscreen.
4Three modes: automatic, semi-automatic, and manual.
Especificações técnicas
Especificações da variante: SED-1YX-K
Especificações
Modelo
SED-1YX-K
Tensão
AC 50Hz, 380V
Utilidades
Pure water: pressure ≥ 0.25 MPa, approx. 400 kg/batch; WFI: pressure ≥ 0.25 MPa, approx. 400 kg/batch; compressed air: 0.6–0.8 MPa, 2.0 m³; electricity: AC 50 Hz, 380 V, total power approx. 28 kW. Piping: main inlet DN=25 mm, secondary inlet DN=25 mm, upper discharge DN=100 mm, drain DN=50 mm.
Detalhes de conformidade
Designed and manufactured per China GMP standard; materials,surface finish,rounded transitions,process piping welds,and installation fully comply with GMP. Cross-referenced against EU cGMP and US FDA standards. Equipment establishes complete production and quality control records,traceable and auditable. Supports electronic signature and three-level password management.
Potência
28 kW
Pressão de ar
0.6-0.8MPa/2.0m³
Dimensões
Comprimento
1800 mm
Largura
1600 mm
Altura
1800 mm
Peso
1800 kg
Área de instalação
Overall dimensions: 1,800 × 1,600 × 1,800 mm. Requires: pure water ≥ 0.25 MPa / 400 kg; water for injection ≥ 0.25 MPa / 400 kg; compressed air 0.6–0.8 MPa / 2.0 m³; AC 50 Hz, 380 V power.
Materiais
Materiais de contato
316L stainless steel (cleaning drum); 304 stainless steel (cleaning tank, feed/discharge hopper, piping); PTFE (Teflon) gaskets and seals; medical silicone rubber seals; PDFE/PVDF as needed
Materiais do corpo
Carbon steel frame; 304 stainless steel brushed plate (housing,thermal insulation cover); chlorine-free aluminum silicate rock wool insulation
Características principais
Washing, rinsing, drying, and cooling in a single closed chamber
Eliminates cross-contamination
PLC + color LCD touchscreen control; full Chinese/English switchable interface
Three-level password authorization management (operator / process engineer / manager)
Electronic signature and electronic records (USB print supported)
Capacity: 10,000 Φ20 rubber stoppers per batch
Drum rotational speed: 0.5–10 rpm (variable frequency, stepless)
Advanced ultrasonic cleaning with vacuum degassing
Self-circulating fine wash (water-saving)
Hot-air drying: 70–150°C
Interior surface finish: Ra ≤ 0.4 µm
316L stainless steel cleaning drum with spiral guide plates for auto-discharge
External drum drive (bearing outside cleaning tank) — prevents contamination
212B-65 acid/alkali-resistant hard alloy + PTFE double mechanical seal
Insulation: chlorine-free aluminum silicate rock wool; outer cover 304 SS brushed plate
Compliant with China GMP, EU cGMP, US FDA standards
4th-generation product — proven over 10+ years, deployed in 30+ provinces nationwide and exported internationally
Fully closed single-pass process eliminates cross-contamination
Self-circulating fine wash significantly reduces water consumption
Online monitoring, detection, and control; traceable electronic records
Compliant with China GMP, EU cGMP, and US FDA standards
Capacity 10,000 stoppers/batch; drum speed 0.5–10 rpm (VFD stepless)
Aplicações
Rubber stopper cleaning and drying
Aluminum cap cleaning
Pharmaceutical injectable component cleaning
Setores
Pharmaceutical injectable manufacturing
Antibiotic powder injection
Water for injection (WFI) production
Marcas dos componentes
Siemens — PLC and color LCD touchscreen
Schneider — AC contactor (LC1N0610), thermal overload relay (CDG3-DA), relay (RXM2ABABD), power supply, rotary switch, signal lights and buttons
Delta — inverter/frequency converter
Wolken — external mechanical seal (212B-65,acid/alkali-resistant hard alloy + PTFE)
Jiangsu Changzhou — cycloidal pin-wheel reducer (BWD131-289, motor 1.1 kW)
Qingdao — blower fan (DE-160, 380V/1.1 kW)
Nanfang Pump Industry (Hangzhou joint venture) — cleaning water pump (8-30)
Wenzhou suppliers — sanitary thin-wall stainless steel piping (304 SS), quick-release clamps, silicone gaskets, fittings
SED
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Conformidade
GMP (China)
cGMP (EU)
FDA (US) standard reference
Limpeza e manutenção
All process steps (washing, rinsing, drying, cooling) complete automatically in sequence. The cleaning drum interior and spiral guides have Ra ≤ 0.4 µm mirror finish; tank interior Ra ≤ 0.4 µm. Self-circulating fine wash uses pump + filtration to recirculate cleaning water through center spray. After each batch, drainage via electromagnetic valve; drum reverse-rotation for automatic discharge. Maintenance access via side and rear doors; large-diameter discharge opening doubles as manhole for internal cleaning.
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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