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SED-KJTZ-L
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SED-KJTZ-L
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SED-KJTZ-L — Rubber Stopper Aseptic Closed-Barrel Transfer System
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
The SED-KJTZ-L is an aseptic closed-barrel transfer system for pharmaceutical rubber stoppers,comprising: (1) an open Restricted Access Barrier System oRABs (model GLG1400-GD/SED-KJTZ-L) installed at the discharge end of
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Como funciona
A sterilized transfer barrel is brought into the oRABs isolation cabinet (after self-purification for 10–15 min to achieve Class A). Via glove ports, the operator opens the barrel lid and aligns it with the washer discharge nozzle. The washer discharge cycle fills the barrel. The lid is sealed and locked via gloves. The barrel is moved sideways by rollers onto the flat transfer cart. The cart is pushed to the filling machine, its rollers lifted to the filling platform height. Via the filling line side door, the barrel is transferred to the filling line oRABs and stoppers are manually scooped into the buffer hopper for filling.
Processo de funcionamento
1A sterilized transfer barrel is brought into the oRABs isolation cabinet (after self-purification for 10–15 min to achieve Class A).
2Via glove ports, the operator opens the barrel lid and aligns it with the washer discharge nozzle.
3The washer discharge cycle fills the barrel.
4The lid is sealed and locked via gloves.
5The barrel is moved sideways by rollers onto the flat transfer cart.
6The cart is pushed to the filling machine, its rollers lifted to the filling platform height.
7Via the filling line side door, the barrel is transferred to the filling line oRABs and stoppers are manually scooped into the buffer hopper for filling.
Especificações técnicas
Especificações da variante: GLG1400-GD (oRABs base model)
Especificações
Modelo
SED-KJTZ-L
Tensão
AC 220V 50Hz
Utilidades
AC 220V 50Hz, 1 kW. Gloves and HEPA filter consumables; 2× Philips 8W UV-C lamps for sterilization; Dwyer differential pressure sensors.
Detalhes de conformidade
Internal cabinet cleanliness: Class A / ISO 5 (Class 100). Operating environment: Class B background. HEPA H14 filter, 99.995% efficiency at 0.3 μm. Differential pressure 5–10 Pa to room. Air velocity 0.36–0.54 m/s. Total noise <70 dBA. PAO test port included. Surface finish Ra≤0.8.
Potência
1 kW
Dimensões
Comprimento
1400 mm
Largura
650 mm
Altura
2550 mm
Peso
300 kg
Área de instalação
oRABs dimensions: 1400 × 650 × 2550 mm; net weight 300 kg. Height from ground adjustable.
Materiais
Materiais de contato
316L stainless steel (closed wide-mouth barrels); SUS304 stainless steel + PTFE rollers; HYPALON gloves
Materiais do corpo
SUS304 stainless steel frame (50×50 box tubing) and panels; 8mm transparent PC endurance board; 8mm tempered glass operating door; 6mm glass side door
Características principais
Open RABs (oRABs) with Class A / ISO 5 internal environment
HEPA H14 filter at 99.995% efficiency on 0.3 μm particles; initial resistance ≤160 Pa, final 300 Pa
German EBM direct-drive radial fan (noise 49–53 dBA)
Two HYPALON glove ports (NORTH USA, Dia 250 mm × L 810 mm, δ 0.4 mm)
Two UV-C sterilization lamps (8W Philips)
Stainless-steel powerless roller conveyor (SUS304 + PTFE φ38) for friction-free bucket transfer
Electric lifting side door
Online Dwyer differential pressure monitoring (0–500 Pa HEPA both-ends; 0–60 Pa inside-outside)
Temperature and humidity monitoring (18–26°C; 45–65% RH)
PAO test port for HEPA validation
Two 316L closed wide-mouth barrels (φ400×500 mm) with snap-lock lids (included in system)
Siemens S7-200 Smart PLC + 7" Proface HMI
Adjustable overall floor height
Maintains aseptic Class A environment for stopper transfer between washer and filler
Eliminates manual exposure of sterilized stoppers to Class B environment
Premium components: Siemens PLC, Dwyer pressure sensors, German EBM blower, NORTH USA gloves, Philips UV/lighting
Adjustable floor height for matching different equipment platforms
Door interlock with open-door alarm for operator safety
Complete turnkey system: oRABs + 2 barrels included
Aplicações
Aseptic transfer of cleaned/sterilized rubber stoppers from washer to filling line
Buffer station between stopper washer and capping machine
Class A barrier for sterile component handling in injectable manufacturing
Setores
Sterile injectable manufacturing (powder injection, water injection)
Aseptic pharmaceutical filling lines
Vaccine and biologics filling
Marcas dos componentes
Siemens S7-200 Smart-SR40 — PLC (Germany)
Siemens EM DR08, EM AM06, EM AE04 — I/O modules
Proface 7" — HMI (Japan)
EBM Germany — HEPA blower
Philips 14W — Fluorescent lamp (Netherlands)
Philips 8W × 2 — UV lamp (Netherlands)
NORTH USA — HYPALON gloves
Dwyer — Differential pressure sensors (USA)
CHNT/9A — Contactor (China)
Mean Well / MW 50W DC24V — Switching power supply
Klockner Moeller/P1-32 — Breaker
MRO/220V-50V — Transformer
SED
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Especialistas em equipamentos · contato pelo WhatsApp
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Limpeza e manutenção
Self-purge for 10–15 minutes after startup; verify air velocity, particle count, floating and sedimentation bacteria (optional). Surfaces Ra≤0.8 are wipe-cleanable. SUS304+PTFE rollers prevent metal-on-metal friction debris. After each batch, rotate the washer discharge nozzle to cleaning/sterilization state and power off.
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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