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SED-2400RZGF-Q
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SED-2400RZGF-Q
SED · SED-2400RZGF-Q · Hervorgehoben

SED-2400RZGF-Q — Non-PVC Soft Bag Form-Fill-Seal Machine

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SED-2400RZGF-Q Fully-automatic Non-PVC Soft Bag Form-Fill-Seal (FFS) Line for IV solution / large-volume parenteral bags. Two-bag-per-cycle (2 bags/group) configuration. Capacity: 2400 bags/h (100/250ml), 2200 bags/h (50

GMPFDA
Lieferzeit
Auf Anfrage
Durchsatz
2400 Stück/h

Funktionsweise

Non-PVC film roll is unwound (motor-driven with castoring wheel for tension; pneumatic clamp; out-of-film alarm). Hot-stamp printing prints batch info onto bag with ±0.5°C temperature control, adjustable time and pressure. Film is gripped and transferred linearly by motor through stations. A film opener wedge separates the two layers for port insertion. Pre-heated ports (preheat station, ±0.5°C) are picked from feeder bowl, placed between film layers, and contour-welded around bag perimeter while perimeter is also cut. Waste film is gripped pneumatically and dumped to waste box. Bags flip down for vacuum leak detection — leakers and missing bags skip filling. Filling station has 2 filling valves with individual mass flow meters and product distributor; filling system designed for inline CIP and 125°C SIP. Caps are buffered, fed via feeder bowl, vacuum-held above port, and welded by single heater (cylinder pre-compacts cap to prevent drop, single-heater design reduces maintenance). Finished bags are gripped and transferred onto outfeed conveyor.

Prozessbeschreibung
1Non-PVC film roll is unwound (motor-driven with castoring wheel for tension; pneumatic clamp; out-of-film alarm).
2Hot-stamp printing prints batch info onto bag with ±0.5°C temperature control, adjustable time and pressure.
3Film is gripped and transferred linearly by motor through stations.
4A film opener wedge separates the two layers for port insertion.
5Pre-heated ports (preheat station, ±0.5°C) are picked from feeder bowl, placed between film layers, and contour-welded around bag perimeter while perimeter is also cut.
6Waste film is gripped pneumatically and dumped to waste box.
7Bags flip down for vacuum leak detection — leakers and missing bags skip filling.
8Filling station has 2 filling valves with individual mass flow meters and product distributor; filling system designed for inline CIP and 125°C SIP.
9Caps are buffered, fed via feeder bowl, vacuum-held above port, and welded by single heater (cylinder pre-compacts cap to prevent drop, single-heater design reduces maintenance).
10Finished bags are gripped and transferred onto outfeed conveyor.

Technische Daten

Technische Daten für Variante: SED-2400RZGF-Q

Technische Daten

Modell
SED-2400RZGF-Q
Durchsatz
2400 Stück/h
Spannung
3φ AC 380V, 50Hz
Leistung
10 kW
Luftdruck
0.5-0.75 MPa, dry oil-free, ~1800 L/min

Abmessungen

Länge
4350 mm
Breite
1900 mm
Höhe
1800 mm

Werkstoffe

Kontaktwerkstoffe
AISI 316L Edelstahl; pharmaceutical-grade silicone rubber and tool steel — FDA + GMP compliant
Gehäusewerkstoffe
AISI 304L stainless steel framework; polycarbonate safety doors and windows

Wesentliche Merkmale

Two bags per cycle (2 bags/group) production
Multi-format: 100ml / 250ml / 500ml / 1000ml soft bags
Capacity 2400/2200/1800 bags/h respectively
Hot-stamp printing with ±0.5°C temperature control
Filling pressure 0.2-0.4 MPa, max 85°C, accuracy ±1.0%
Mass flow meter dosing per filling head
50.5 standard tri-clamp product connection
Inline CIP (manual start) and SIP up to 125°C — interface standard, modules optional
Pass rate ≥99.99%, leak rate ≤0.01%
Vacuum bag flip leak detection — leaker/no-bag skips filling
Single-heater cap weld design — low maintenance
Pre-compaction cylinder prevents cap drop into heater
Heating-plate / mold-separation design — easy mold replacement
Mold flatness/parallelism tolerance within 1%mm — push-and-use
Industrial fieldbus network simplifies wiring and reduces error points
AISI 304L frame, AISI 316L product contact, polycarbonate guards
Includes 4 sets of molds; additional formats $16,000/set
Hot-stamp print template optional ($500/set)
Out-of-film alarm and out-of-print-ribbon detection
Operated by 1 permanent + 1 occasional operator
Chinese/English HMI
Noise Max.75dB
FDA + GMP compliant — pharmaceutical large-volume parenteral
Industry-leading temperature precision (±0.5°C) on all heating stations
Zero-tolerance manufacturing process (mold flatness/parallelism within 1%mm)
Comprehensive simple-design philosophy: minimal labor, easy maintenance
Festo + Omron + Schneider + Tox + IFM/Festo + Keyence + MISUMI premium components
150-day delivery; 10-20 day overseas commissioning by 1-2 engineers
Free domestic training of customer's overseas engineers

Anwendungen

Non-PVC soft bag IV solutions (saline, dextrose, electrolyte)
Large volume parenteral (LVP) 100ml/250ml/500ml/1000ml
Pharmaceutical liquid bag form-fill-seal

Branchen

Pharmaceutical injectables
Hospital pharmacy / IV solutions

Komponentenhersteller

Control system (HMI, servo, temp control)
Omron
Pneumatic system
Festo
Electrical components (breakers, relays, terminals)
Schneider, Omron, Phoenix
Pressurized oil-air cylinder
Tox
Sensors
IFM or Festo
Fiber optic sensors
Keyence
Linear rails, bearings, buffers, washers
MISUMI
SED
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Konformität

GMP
FDA

Dokumentation

Datenblatt (PDF)
Überblick, technische Daten und Abmessungen · Originaldokument (Englisch)
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Bedienhandbuch
Einrichtung, Betrieb und Fehlersuche · Originaldokument (Englisch)
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Vergleichsdatenblatt (Standard und Economy)
Vergleich der Konfigurationen · Originaldokument (Englisch)
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IQ / OQ / PQ-Protokolle
Validierungsunterlagen zur GMP-Konformität · Originaldokument (Englisch)
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FAT / SAT-Protokolle
Abnahmeprüfungen im Werk und vor Ort · Originaldokument (Englisch)
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CAD-Zeichnungen (STEP / IGES / DWG)
Konstruktionszeichnungen für die Aufstellung · Originaldokument (Englisch)
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Kalibrierzertifikate
Schallpegel, Erdungswiderstand, Spannungsfestigkeit und Rauheit · Originaldokument (Englisch)
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DQ (Designqualifizierung)
Vollständiges Designqualifizierungsprotokoll · Originaldokument (Englisch)
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Werkstoffzeugnisse
Zusammensetzung des Edelstahls 316L · Originaldokument (Englisch)
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