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SED-2500RZGF-Q
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SED-2500RZGF-Q
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SED-2500RZGF-Q — Non-PVC Soft Bag Form-Fill-Seal Machine
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SED-2500RZGF-Q automatic non-PVC soft bag form-fill-seal (FFS) line for pharmaceutical infusion bags. Forms two bags per cycle, each with two SFC ports. Compatible with 50–1000 ml non-PVC infusion soft bags. Rated output
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Prazo de entrega
Consultar
Capacidade de produção
1800–2500 unidades/h
Como funciona
Single-track linear FFS system with motor-driven film transfer via pneumatic grippers. Film passes through twelve stations: (01) motor-controlled unwinding with castoring wheel buffer; (02) hot-foil printing with ±0.5 °C precision; (03) film transfer with film opener for port insertion; (04) contour welding and cutting with port pre-adhesion (±0.5 °C control); (05) port pre-heating; (06) port feeding via feeder bowl and buffer; (07) port welding (±0.5 °C control); (08) waste-edge ejection; (09) bag flip and leak detection (empty bags checked by vacuum — leaking or absent bags bypass filling); (10) two filling systems with Endress+Hauser mass flow metering (±1.0% accuracy, max fill temp 85 °C); (11) cap station with feeder bowl, vacuum pick, and welding; (12) bag outfeed via conveyor belt. Bus-based industrial network simplifies wiring.
Processo de funcionamento
1Single-track linear FFS system with motor-driven film transfer via pneumatic grippers.
2Film passes through twelve stations: (01) motor-controlled unwinding with castoring wheel buffer; (02) hot-foil printing with ±0.5 °C precision; (03) film transfer with film opener for port insertion; (04) contour welding and cutting with port pre-adhesion (±0.5 °C control); (05) port pre-heating; (06) port feeding via feeder bowl and buffer; (07) port welding (±0.5 °C control); (08) waste-edge ejection; (09) bag flip and leak detection (empty bags checked by vacuum — leaking or absent bags bypass filling); (10) two filling systems with Endress+Hauser mass flow metering (±1.0% accuracy, max fill temp 85 °C); (11) cap station with feeder bowl, vacuum pick, and welding; (12) bag outfeed via conveyor belt.
3Bus-based industrial network simplifies wiring.
Especificações técnicas
Especificações da variante: SED-2500RZGF-Q (~1800 L/min compressed air)
Especificações
Modelo
SED-2500RZGF-Q
Capacidade de produção
1800–2500 unidades/h
Tensão
3 Phase 380V 50Hz
Utilidades
3-phase 380V 50Hz electrical (max 10 kW); compressed air 0.5–0.75 MPa dry oil-free at ~1800 L/min (SED-2500RZGF-Q variant) or ~1000 L/min (SED-2500RZGF-Q1 variant); filling pressure 0.3–0.45 MPa; optional cooling water; optional nitrogen; recommended room conditions 20–24 °C, 45–65% RH (max 85% RH)
Detalhes de conformidade
Designed for pharmaceutical use according to GMP and FDA guidelines. All product-contact components use AISI 316L stainless steel, mold steel, and silicone rubber meeting FDA and GMP standards.
Potência
10 kW
Pressão de ar
Compressed air 0.5-0.75 MPa, dry oil-free; consumption ~1800 L/min (1000 L/min for SED-2500RZGF-Q1 variant); filling pressure 0.3-0.45 MPa
Dimensões
Comprimento
4350 mm
Largura
1900 mm
Altura
1800 mm
Área de instalação
4350 mm (L, including film roll) × 1900 mm (W, including protective enclosure) × 1800 mm (H, including protective enclosure)
Materiais
Materiais de contato
AISI 316L aço inoxidável; mold steel; silicone rubber (FDA/GMP compliant)
Materiais do corpo
AISI 304L stainless steel framework; polycarbonate safety doors and windows
Características principais
Precise temperature control within ±0.5 °C ensures compatibility with all qualified non-PVC film materials
Zero-tolerance manufacturing: mold flatness/parallelism within 1/100 mm for tool-free exchange
Advanced industrial network (bus system) connecting valve terminals and limit switches — reduces wiring and maintenance errors
Leak detection at station 09: leaking or absent bags are automatically skipped at filling
Unique mold-and-heating-plate separation design for extremely fast mold change without special tools
In-line sterilisation (CIP/SIP) up to 125 °C available as option
Min. 99.97% pass rate based on qualified materials and correct operation
Waste-edge rejection rate 99.99% with independent waste collection tray
Noise ≤75 dB
GMP and FDA compliant design
High productivity: 2500 bags/h (50 ml) on compact 4350×1900×1800 mm footprint
One permanent operator; second operator only during film change
Fully integrated 12-station continuous FFS — no intermediate handling
Optional CIP/SIP in-line cleaning and steam sterilisation at 125 °C
Compatible with 50–1000 ml bags; adding new size only requires purchasing additional molds
Omron control platform (PLC, HMI, servo, temperature); Festo pneumatics; E+H flow meters
Aplicações
Pharmaceutical infusion soft bag form-fill-seal for non-PVC bags 50–1000 ml
Two-bag per cycle FFS production
Bags with two SFC ports per bag
Setores
Pharmaceutical injectable / infusion manufacturing
Marcas dos componentes
Control system / PLC / HMI / servo / temperature control
Omron
Pneumatic system (cylinders, valve islands, service units)
Festo
Mass flow meter (filling accuracy control)
Endress+Hauser (E+H)
Pressurized oil-air cylinder
TOX
Sensors
IMF
SED
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Conformidade
GMP compliant design
FDA-compliant materials
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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