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SED-4-2FGS-3
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SED-4-2FGS-3
SED · SED-4-2FGS-3 · Hervorgehoben

SED-4-2FGS-3 — High-Speed 4-Head Screw-Type Powder Filling and Stoppering Machine

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SED-4-2FGS-3 high-speed 4-head screw-type powder filling and stoppering machine for 5–20 ml vials. Designed throughput 250 bottles/min @0.5 g (5 ml vial), stable 200 bottles/min. Mitsubishi servo-driven dosing screws (4

GMP
Variante wählen (2)
Lieferzeit
Auf Anfrage
Durchsatz
200–250 Flaschen/min

Funktionsweise

Vials feed via 304 SS turntable into the linear infeed track and reach the rotary positioning station, where a Mitsubishi servo-driven star-wheel locks each vial in place (servo-current sensing detects jams and prevents bottle breakage). The 316L stainless steel powder hopper holds the API powder; a low-speed permanent-magnet motor drives the powder-feed screw to maintain head pressure at the dosing screws. Each of 4 servo-driven dosing screws (Mitsubishi 400W) rotates a programmable count to deliver the set fill weight (0.1–5.0 g). Optional secondary or tertiary fill cycles per bottle for tricky powders. After fill, vials transit on the conveyor to the vacuum-free rotary stopper-pressing system: a chopstick-style mechanism delivers each rubber stopper into a spring-loaded cap-pressing disc with a rising cam — vials rotate vertically as they rise, no vacuum needed. No-stopper detection by Leuze sensor triggers auto-rejection. Production statistics counted by Panasonic photoeye; Siemens 12" HMI provides 3-level password lockout, jog/auto modes, recipe storage, fault history.

Prozessbeschreibung
1Vials feed via 304 SS turntable into the linear infeed track and reach the rotary positioning station, where a Mitsubishi servo-driven star-wheel locks each vial in place (servo-current sensing detects jams and prevents bottle breakage).
2The 316L stainless steel powder hopper holds the API powder; a low-speed permanent-magnet motor drives the powder-feed screw to maintain head pressure at the dosing screws.
3Each of 4 servo-driven dosing screws (Mitsubishi 400W) rotates a programmable count to deliver the set fill weight (0.1–5.0 g).
4Optional secondary or tertiary fill cycles per bottle for tricky powders.
5After fill, vials transit on the conveyor to the vacuum-free rotary stopper-pressing system: a chopstick-style mechanism delivers each rubber stopper into a spring-loaded cap-pressing disc with a rising cam — vials rotate vertically as they rise, no vacuum needed.
6No-stopper detection by Leuze sensor triggers auto-rejection.
7Production statistics counted by Panasonic photoeye; Siemens 12" HMI provides 3-level password lockout, jog/auto modes, recipe storage, fault history.

Technische Daten

Technische Daten für Variante: SED-200XZG-Z 20-head rotary capper (300 bpm design / 250 bpm stable @5ml

Technische Daten

Modell
SED-4-2FGS-3
Durchsatz
200–250 Flaschen/min
Spannung
380V
Versorgung
380V, ~10 kW; vacuum -6×10⁻² MPa, 30–60 L/min (for online sampling/rejection); clean compressed air 0.2–0.4 MPa, 0.5–2 m³/h; customer provides vacuum source and compressed air
Leistung
10 kW
Luftdruck
0.2-0.4 MPa, 0.5-2 m³/h (clean compressed air)

Abmessungen

Gewicht
2800 kg
Aufstellfläche
Dimensions per machine drawing (see technical drawing); weight ~2800 kg

Werkstoffe

Kontaktwerkstoffe
316L stainless steel (powder hoppers, dosing screws, stirring agitators, cap track, stopper guides, pinch fittings); ceramic (powder-feed screw bearings); engineering plastic (rails); polyoxymethylene (POM) — turret pucks; transparent thermoplastic (autoclavable trial bowl)
Gehäusewerkstoffe
304 stainless steel (machine frame, doors, table); tempered glass (door panels); 304 SS + POM (infeed turntable)

Wesentliche Merkmale

4-head Mitsubishi servo-driven dosing screws (400W each)
Programmable screw revolutions for 0.1–5.0 g dose precision (±3–4% at 0.5–2g, ±4% at 0.3g)
Mitsubishi servo bottle-positioning star-wheel (auto zero-find, no operator re-positioning)
Industry-first vacuum-free rotary stopper-pressing system — saves vacuum/air, better N2 protection
Compatible with concave-coated rubber stoppers (where vacuum pickup would fail)
Stoppering success rate ≥99.5%; no-stopper auto-rejection ≥99.5%
316L stainless steel powder hopper, autoclavable at 121°C
Top-cone-positioning one-piece dosing screws (industry-unique) — no set-screw, eliminates dead-zone powder accumulation
Multiple screw types: straight, conical, straight-bottom-conical-top, variable-pitch, special
Ceramic bearings on powder-feed screws — oil-free, easy alcohol/water cleaning
Powder-bin pinch-clamp connection for tool-less swap, autoclavable, with anti-bridging gas-pulse / N2 option
Weight: ~2800 kg; Power: 380V, ~10 kW
Vacuum: -6×10⁻² MPa, 30–60 L/min (online sampling/rejection)
Compressed air: 0.2–0.4 MPa, 0.5–2 m³/h
Bottle breakage ≤0.05%
12" Siemens HMI + 3-level password
Noise ≤70 dBA at 1 m
Industry-leading vacuum-free stopper-pressing — patented, energy-saving, supports N2 inerting without leak
Speed (200–250 bpm) sets a class standard for cephalosporin/antibiotic powder packaging
Top-cone one-piece screws, bowl swap-out, autoclavable hopper, ceramic bearings — best-in-class GMP cleanability
Mitsubishi servo position + servo dosing combo gives reliable, repeatable accuracy across SKUs
Field-proven on dozens of cephalosporin / antibiotic SKUs (cefuroxime, meropenem, ceftriaxone, ceftazidime, etc.) and bear-bile powder
Component pedigree: Siemens PLC + HMI + V20 VFD, Mitsubishi servo (4×400W + 750W), Delta servo for positioning, Panasonic FX101 photoeye, Leuze sensors, German counter, Delixi electrical, Mean Well power

Anwendungen

Sterile cephalosporin / antibiotic powder filling for vials (β-lactam antibiotics)
5–20 ml vial powder injectable production
Bear bile powder and other Chinese-medicine powders
Sterile API powder dosing in vials

Branchen

Pharmaceutical (sterile injectables / antibiotics)

Komponentenhersteller

PLC
Siemens
HMI touchscreen 12"
Siemens
Main servo motor 750W
Mitsubishi
Dosing-screw servo motor 400W ×4
Mitsubishi
Vial-positioning servo motor 400W ×4
Delta
VFD V20 series ×5
Siemens
Powder-feed screw motor 110TDY115S5-2A 11W (permanent magnet)
Suzhou Siaoke
Infeed turntable / track motors
Beijing Microtek
Photo-fiber sensor FX101
Panasonic
Proximity switch LCS / no-stopper sensor
Leuze
Counter (fiber)
German brand
Contactors / relays / breakers / e-stop / buttons
Delixi/Shanghai equivalent
Ceramic bearings on feed screws
(unspecified ceramic)
SED
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Konformität

GMP

Reinigung und Wartung

Ceramic bearings on powder-feed screws are oil-free and cleanable with alcohol or water. Dosing screws, agitators, and powder hoppers are tool-free removable; powder-contact parts autoclavable at 121°C. Machine table surface is groove-folded (no dead angles); support columns are sealed; doors are recessed 40 mm at table edge to prevent water ingress during cleaning.

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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SED
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