Início / Equipamentos / Envasadora e seladora semiautomática de bolsas IV flexíveis / Semi-Automatic IV Soft-Bag Filling and Sealing Machine (Single/Dual-Chamber Compatible)
SED-1-400BRG-Q
Consultar
SED-1-400BRG-Q
SED · SED-1-400BRG-Q · Em destaque
SED-1-400BRG-Q — Semi-Automatic IV Soft-Bag Filling and Sealing Machine
A descrição completa deste modelo ainda está sendo traduzida. Consulte os detalhes em inglês ou solicite informações à nossa equipe. English
The SED-1-400BRG-Q is a semi-automatic IV soft-bag (single/dual-chamber) filling and sealing machine. Single-operator, one bag per cycle. Compatible with single-chamber bags (100-1000 ml single-tube, 100-1000 ml dual-tub
Prazo de entrega
Consultar
Capacidade de produção
200–400 bags/hour
Como funciona
Single-cycle sequence: manual bag loading → pneumatic gripper bag transfer → vacuum → precise volumetric filling via Endress+Hauser Coriolis mass flow meters and pneumatic diaphragm valves → nitrogen flush → stopper insertion → output. CIP is controlled by timed valve open/close sequences. SIP is achieved by measuring effective sterilisation temperature and time. All product-contact piping is sterilisable in-place at 121°C.
Processo de funcionamento
1Single-cycle sequence: manual bag loading → pneumatic gripper bag transfer → vacuum → precise volumetric filling via Endress+Hauser Coriolis mass flow meters and pneumatic diaphragm valves → nitrogen flush → stopper insertion → output.
2CIP is controlled by timed valve open/close sequences.
3SIP is achieved by measuring effective sterilisation temperature and time.
4All product-contact piping is sterilisable in-place at 121°C.
Especificações técnicas
Especificações da variante: SED-1-400BRG-Q
Especificações
Modelo
SED-1-400BRG-Q
Capacidade de produção
200–400 bags/hour
Tensão
220V ±10%, 50Hz
Utilidades
Power: 220V ±10%, 50Hz, 8 kW (including laminar flow); Compressed air: 800 L/min @ 0.65-0.8 MPa, dry oil-free; Pharmaceutical N2: per process requirements; Liquid feed pressure: 0.3-0.6 MPa (foam-free filling at 0.4 MPa). Background cleanroom: Grade C or B. Temperature: 0-45°C; RH <65%. Noise: <75 dB at 1 m.
Detalhes de conformidade
GMP compliant; CE certified; software complies with FDA 21 CFR Part 11. Meets infusion-bag production legal requirements. Price includes VAT, packaging, and domestic freight (excludes warehousing, port handling, and unloading). Payment: 50% pre-payment, 50% on shipment. Lead time: 6 months from contract signing + deposit receipt. Free remote support within 1 year. Operating language: Chinese and English.
Potência
8 kW
Pressão de ar
Compressed air 0.65-0.8 MPa (800 L/min, dry, oil-free); filling pressure 0.4 MPa for foam-free product; product liquid 0.3-0.6 MPa
Dimensões
Comprimento
3000 mm
Largura
1600 mm
Altura
2400 mm
Peso
1000 kg
Área de instalação
L 3000 x W 1600 x H 1800 mm (without laminar flow); H 2400 mm with laminar flow. Final footprint per contract drawings (varies with bag specification).
Materiais
Materiais de contato
SS316 (product pipework, filling heads, all product-contact parts); medical silicone rubber; steam-sterilisable at 121°C
Materiais do corpo
SS304 frame and guarding; high-transparency acrylic (PMMA) viewing panels
Características principais
Single-operator semi-automatic cycle: load → vacuum → fill → N2 flush → stopper → output
Two independent filling systems for dual-chamber bags (two different liquids simultaneously)
Pre-filling vacuum + post-filling nitrogen flush
Includes Class 100 Orabs laminar flow + glovebox integrated protection
Built-in CIP/SIP: all product-contact piping sterilisable at 121°C in-place
Compatible with single and dual-chamber soft bags; bag width up to 300 mm, length ≤350 mm
Filling accuracy: 100-250 ml ±3 g; >250 ml ±1% (E+H Coriolis mass flow meters)
Output: 200-400 bags/hour (at filling pressure 0.4 MPa, foam-free product)
GMP and CE compliant; meets infusion-bag production regulatory requirements
Complete Orabs + laminar flow + glovebox solution included
High-precision E+H Coriolis mass flow meters — 100-250 ml ±3 g; >250 ml ±1%
Full CIP/SIP capability — reduces contamination risk, simplifies batch changeover
Compact semi-automatic footprint for IV bag production
Key brands: Siemens PLC; SMC cylinders/valves; E+H flow meters
Aplicações
Single-chamber IV soft-bag filling (100-1000 ml, single or dual tube)
Single-chamber IV soft-bag filling 2000/3000 ml (non-PVC, dual tube)
Dual-chamber bag filling (two different liquids, total ≤3000 ml)
Sterile IV bag production with laminar flow + glovebox protection
Setores
Pharmaceutical manufacturing (parenteral / IV solutions)
Infusion bag production
Marcas dos componentes
PLC: Siemens
Cylinders and valves: SMC
Sensors: SMC, Keyence
Circuit breakers: Schneider
Diaphragm valves: SED / Gemu
Mass flow meters: Endress+Hauser (E+H) Coriolis mass flow meters
SED
Fale com SED Sales Team
Especialistas em equipamentos · contato pelo WhatsApp
Consulte o horário e a disponibilidade da equipe
Conformidade
GMP compliant
CE certified
FDA 21 CFR Part 11 compliant software (audit trail, multi-level access control)
Limpeza e manutenção
Built-in CIP/SIP. CIP controlled by valve open/close timing sequences. SIP via measured effective sterilisation temperature and time. All product-contact piping sterilisable at 121°C in-place. Product-contact materials are corrosion-resistant and ageing-resistant.
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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