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SED-2-750BRG-Q

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SED-2-750BRG-Q

SED · SED-2-750BRG-Q · Em destaque

SED-2-750BRG-Q — Semi-automatic IV Soft-bag Filling and Sealing Machine

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SED-2-750BRG-Q semi-automatic non-PVC IV soft-bag filling and sealing machine. Single-operator, dual-station design: operator manually loads soft bag, machine automatically vacuum-evacuates, dose-fills, nitrogen-purges,

GMP compliantCE certifiedFDA 21 CFR Part 11 compliant softwareFDA / GMP compliant high-precision mass flowmeterValidation documents: DQ, FAT, IQ, OQ, SATMaterial certificates (304L/316L SS, medical silicone rubber)

Escolher variante (2)

Prazo de entrega

Consultar

Capacidade de produção

100–800 bags/hour

Como funciona

Two-station fill-and-seal cycle: operator manually places empty soft bag into positioning guides within the Orabs glove-box enclosure. The machine detects the bag and executes the following sequence: (A) Vacuum evacuation — vacuum generator, buffer tank, vacuum sensor, and sanitary diaphragm valves create and hold vacuum; evacuation time and level adjustable via touchscreen or vacuum sensor. (B) Dose filling — filling system includes distributor, FDA/GMP-compliant mass flowmeter, sanitary diaphragm valves, and piping; filling volume and calibration set via touchscreen recipe. (C) Nitrogen purge — N₂ system with pressure sensor, diaphragm valve, and piping; N₂ quantity controlled by open/close time. (D) Stopper sealing — stopper vibratory bowl auto-orients and feeds stoppers; machine seals stopper onto filled bag. (E) Output — sealed bag drops onto belt conveyor and exits through the Orabs enclosure. Both filling heads operate in parallel (independent dual systems). All tubing CIP/SIP capable (125 °C rated). Operating language: Russian / English / Chinese switchable.

Processo de funcionamento

1Two-station fill-and-seal cycle: operator manually places empty soft bag into positioning guides within the Orabs glove-box enclosure.

2The machine detects the bag and executes the following sequence: (A) Vacuum evacuation — vacuum generator, buffer tank, vacuum sensor, and sanitary diaphragm valves create and hold vacuum; evacuation time and level adjustable via touchscreen or vacuum sensor.

3(B) Dose filling — filling system includes distributor, FDA/GMP-compliant mass flowmeter, sanitary diaphragm valves, and piping; filling volume and calibration set via touchscreen recipe.

4(C) Nitrogen purge — N₂ system with pressure sensor, diaphragm valve, and piping; N₂ quantity controlled by open/close time.

5(D) Stopper sealing — stopper vibratory bowl auto-orients and feeds stoppers; machine seals stopper onto filled bag.

6(E) Output — sealed bag drops onto belt conveyor and exits through the Orabs enclosure.

7Both filling heads operate in parallel (independent dual systems).

8All tubing CIP/SIP capable (125 °C rated).

9Operating language: Russian / English / Chinese switchable.

Especificações técnicas

Especificações da variante: Single-port soft-bag mode (one filling head disabled)

Especificações

Modelo

SED-2-750BRG-Q

Capacidade de produção

100–800 bags/hour

Tensão

220V 50Hz +-10%

Utilidades

Compressed air: 500 L/min at 0.65–0.8 MPa, dry oil-free. Medical nitrogen (N₂): 0.4 MPa, quantity per process. Filling liquid pressure: 0.3–0.6 MPa (bubble-free liquid). CIP water and clean steam supplied by customer. Power: 220V 50Hz ±10%, rated 5 kW.

Detalhes de conformidade

Complies with infusion-bag filling pharmaceutical regulations. CE certified. FDA 21 CFR Part 11 compliant software (password aging, complexity policy; 3–4 level user matrix; audit trail; non-editable report export). Mass flowmeter compliant with FDA and GMP.

Potência

5 kW

Pressão de ar

0.65-0.8 MPa (500 L/min, dry oil-free); medical N2 0.4 MPa

Dimensões

Comprimento

1500 mm

Largura

2000 mm

Altura

2400 mm

Peso

800 kg

Área de instalação

L <1500 mm × W <2000 mm × H <2400 mm (actual dimensions depend on bag type and port configuration; confirmed at contract drawing stage). Operating environment: background C/B grade clean room; temperature 0–45 °C; relative humidity <65%; noise <75 dB at 1 m.

Materiais

Materiais de contato

316L stainless steel (all product-contact piping, valves, filling heads); medical-grade silicone rubber (seals, tubing); 304L stainless steel (main structural components, electrical cabinet)

Materiais do corpo

304L stainless steel main structure; SS304 electrical cabinet (IP54); transparent acrylic (Orabs doors with glove ports); Orabs frame 304 SS welded

Características principais

Two independently operable filling heads (single-port mode by disabling one head)

Vacuum + fill + N₂ purge sequence with two independent parallel systems

FDA/GMP-compliant high-precision mass flowmeter for accurate dosing

Filling accuracy: 100–500 mL ±5 g; 1000–5000 mL ±10 g

Orabs (Open Restricted Access Barrier System) with H14 HEPA filter and glove ports

Grade A laminar flow with adjustable air speed, PAO test port, pressure differential gauge

Tubing fully CIP/SIP capable (withstands 125 °C); SIP with temperature sensors and steam traps

FDA 21 CFR Part 11 compliant software; 3–4 level user permission matrix; audit trail

Compatible with 100–5000 mL non-PVC bags: single-port and dual-port types

Output conveyor belt exits through Orabs enclosure (belt length ≤1.5 m)

Operating language: Russian / English / Chinese switchable

Power 5 kW rated; 220V 50Hz ±10%; air 500 L/min at 0.65–0.8 MPa; medical N₂ 0.4 MPa

Throughput: 100–800 bags/h (rated 750 bags/h); weight ≤800 kg; dimensions L<1.5 m × W<2 m × H<2.4 m

SS304 electrical cabinet (IP54) installed below operating area, not obstructing operation

Emergency stop; safety door interlocks; laminar flow interlock; all actuator interlocks; alarm logging

GMP compliant, CE certified, meets infusion-bag manufacturing regulations

Compact footprint (under 1.5 m × 2 m × 2.4 m), high yield and qualification rate

Stable stoppering with precise positioning, ensures sealing qualification rate

FDA 21 CFR Part 11 compliant software with audit trail and non-editable reports

Orabs with H14 HEPA enables Grade A laminar flow without full isolator cost

Simple operation, stable running; one operator can run the machine

Included documentation: DQ, FAT, IQ, OQ, SAT; remote support 1 year

Aplicações

IV soft-bag filling and sealing (non-PVC)

Non-PVC infusion bags 100–5000 mL

Single-port and dual-port soft bags

Multi-chamber bag filling (triple-chamber, dual-chamber, liquid-liquid, liquid-powder)

Setores

Pharmaceutical (IV infusion / parenterals)

Aseptic / sterile fill-finish manufacturing

Marcas dos componentes

PLC

Siemens equivalent or better

Pneumatic cylinders and valves

SMC equivalent or better

Sensors

SMC / Keyence equivalent or better

Low-voltage electrics

Schneider equivalent or better

SED

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Conformidade

GMP compliant

CE certified

FDA 21 CFR Part 11 compliant software

FDA / GMP compliant high-precision mass flowmeter

Validation documents: DQ, FAT, IQ, OQ, SAT

Material certificates (304L/316L SS, medical silicone rubber)

Limpeza e manutenção

Filling tubing designed for CIP/SIP. CIP: time-controlled inline cleaning valve open time adjustable via touchscreen. SIP: temperature sensors and steam traps; sterilization temperature and time settable; withstands 125 °C. Customer supplies CIP water and superheated steam. Equipment provides piping and interfaces only.

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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