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SED-8-12YTGX-F
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SED-8-12YTGX-F
SED · SED-8-12YTGX-F · Hervorgehoben

SED-8-12YTGX-F — Vial Filling Production Line

Die vollständige Beschreibung dieses Modells wird noch übersetzt. Lesen Sie die englischen Details oder fragen Sie unser Team nach weiteren Informationen. English

SED-8-12YTGX-F Vial Filling Production Line is an integrated four-machine sterile vial line composed of: (1) SED-60CXP-F Vertical Ultrasonic Vial Washer (60-head, 100-160 vials/min, 12.35 kW, ultrasonic 2 kW); (2) SED-RX

FDA compliantEU GMP compliantChina new GMP compliantElectrical compliance with GB 5226-85
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Lieferzeit
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Durchsatz
100–160 vials/min

Funktionsweise

Vials enter the SED-60CXP-F ultrasonic washer: bottle feed → water-fill → ultrasonic cavitation pre-clean (2 kW) → screw separator → high-precision SS manipulator inverts vials 180° → 6-station fine wash (recycled water → compressed air → sub-WFI → compressed air → WFI → compressed air) → exit upright. Cleaned vials pass through the SED-RXG-F tunnel oven on a 304 SS mesh belt: pre-heat zone → high-temp sterilization zone (250-300°C, ≥5 min, ±5-10°C uniformity, ±2 Pa pressure balance) → cool-down zone (<40°C exit). Sterile vials enter the SED-8-12XGS-F: feeder turntable → conveyor → filling station where 8 pump heads (magnetic pump for gel via 3-way rotary valve, or peristaltic for liquid) fill each vial, with descending fill needles that rise with liquid level to prevent foaming; PLC-servo controls dosing. Filled vials index on a nylon dial wheel to the 12-head rotary stopper station (vacuum suction pickup; no-bottle-no-stopper); half-stopper option for lyophilization. Stopppered vials transfer to the SED-8ZG-F capper: aluminum caps oriented by vibrating bowl → single-knife continuous rolling crimp at 100-120 vials/min.

Prozessbeschreibung
1Vials enter the SED-60CXP-F ultrasonic washer: bottle feed → water-fill → ultrasonic cavitation pre-clean (2 kW) → screw separator → high-precision SS manipulator inverts vials 180° → 6-station fine wash (recycled water → compressed air → sub-WFI → compressed air → WFI → compressed air) → exit upright.
2Cleaned vials pass through the SED-RXG-F tunnel oven on a 304 SS mesh belt: pre-heat zone → high-temp sterilization zone (250-300°C, ≥5 min, ±5-10°C uniformity, ±2 Pa pressure balance) → cool-down zone (<40°C exit).
3Sterile vials enter the SED-8-12XGS-F: feeder turntable → conveyor → filling station where 8 pump heads (magnetic pump for gel via 3-way rotary valve, or peristaltic for liquid) fill each vial, with descending fill needles that rise with liquid level to prevent foaming; PLC-servo controls dosing.
4Filled vials index on a nylon dial wheel to the 12-head rotary stopper station (vacuum suction pickup; no-bottle-no-stopper); half-stopper option for lyophilization.
5Stopppered vials transfer to the SED-8ZG-F capper: aluminum caps oriented by vibrating bowl → single-knife continuous rolling crimp at 100-120 vials/min.

Technische Daten

Technische Daten für Variante: SED-60CXP-F (washer

Technische Daten

Modell
SED-8-12YTGX-F
Durchsatz
100–160 vials/min
Spannung
380V 50Hz 3Φ
Versorgung
380V 50 Hz 3-phase 4-wire power. Compressed air: 0.25-0.35 MPa, 60 m³/h (washer). Purified/WFI water: 0.25-0.35 MPa, 1 m³/h (washer). Exhaust ventilation for tunnel oven (exhaust fan provided by customer).
Leistung
3.5 kW

Abmessungen

Länge
2000 mm
Breite
1200 mm
Höhe
1800 mm
Aufstellfläche
Washer (SED-60CXP-F): 2400×1400×1200 mm. Tunnel (SED-RXG-F): 4000×1600×2450 mm. Filler/stopperer (SED-8-12XGS-F): 2000×1200×1800 mm. Capper (SED-8ZG-F): 1700×1300×1850 mm. Power supply: 380V 50 Hz 3-phase 4-wire. Total installed power ≈ 100 kW (washer 12.35 + tunnel 78 + filler 3.5 + capper 6).

Werkstoffe

Kontaktwerkstoffe
316L stainless steel (filling needles, all liquid-contact wetted parts on filler, sanitary diaphragm valves); 304 stainless steel (washer water tank, manipulator, tunnel mesh belt, capper turntable parts); food-grade silicone hose (peristaltic pump tubing); POM (polyoxymethylene) for dial wheels and turntables; PEEK / ceramic / silicone for select fluid-path parts
Gehäusewerkstoffe
304 stainless-steel brushed-finish exterior on all four machines; transparent organic-glass guards on washer; tempered-glass + 304 SS doors on capper; smooth-folded GMP deck with no welds and no dead corners

Wesentliche Merkmale

Integrated 4-machine sterile vial line (washer + tunnel + filler/stopperer + capper)
Ultrasonic + 6-station fine wash — FDA/EU/China new-GMP compliant
Hot-air tunnel sterilization at 250-300°C with ±5-10°C uniformity and ±2 Pa pressure balance
8-head magnetic OR peristaltic pump filling for 1-10 ml vials
Dual-mode filling: gel via 3-way rotary valve + liquid via peristaltic pump
12-head rotary stoppering with vacuum suction pickup
Half-stopper / full-stopper capability (lyophilization-ready)
Single-knife rolling capper at 100-120 vials/min
GMP audit trail across all four machines
All liquid-contact parts in 316L SS; silicone/food-grade hoses
Siemens PLC/HMI, Schneider VFD/breakers, Panasonic/Mitsubishi servo throughout
Single-vendor sterile vial line — no integration risk between washer / tunnel / filler / capper
Dual-pump filling (magnetic + peristaltic) covers liquid and gel formulations on the same machine
Half-stoppering supports lyophilization workflows out of the box
Complete audit trail + GMP design — pharma injection registration-ready
Premium controls: Siemens PLC/HMI, Schneider VFD/breakers, Mitsubishi servo, OMRON sensors

Anwendungen

Sterile pharmaceutical injection vial filling
Lyophilization vial half-stoppering and capping lines
Vaccines, biologics, blood products vial lines
Veterinary injectable lines

Branchen

Pharmaceutical injection
Vaccine and biologics
Blood products
Veterinary injection

Komponentenhersteller

PLC
Siemens
Touch screen / HMI
Siemens
VFD
Schneider / Siemens
Filling magnetic pump
Custom (Shenzhen) with servo control
Servo motor (filler)
Panasonic / Mitsubishi
Cleaning water pump (washer)
Hangzhou Nanfang (32-25-160, all-SS)
Ultrasonic generator
Jining (D28-2000)
Main electrical (washer)
Schneider
Level controller
Shanghai SIPAI (HL-2S)
Conveyor chain (washer)
Suzhou Chain Factory (SS)
VFD (tunnel)
Delta 0.75 kW
Tunnel heating elements (20×1.5 kW finned tube)
Jiangyan Xinghuo
Centrifugal blower (tunnel)
Hongda Group (YDF2.2×4S)
Temperature sensor (tunnel)
Shanghai SIPAI Pt100 Grade-A
SED
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Konformität

FDA compliant
EU GMP compliant
China new GMP compliant
Electrical compliance with GB 5226-85

Reinigung und Wartung

Washer: flush liquid-contact paths with WFI after each batch; ultrasonic tank has drain port and slag port for easy glass-fragment removal; all process piping has slope for self-draining — no residual liquid retained; food-grade sanitary flexible hoses; water/air circuits fully independent (no cross-contamination). Filler: product-contact wetted parts (316L SS needles, diaphragm valves, silicone tubing) should be disassembled and sterilized per site SOP before each batch.

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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