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SED-5CYGF-K
Auf Anfrage
SED-5CYGF-K
SED · SED-5CYGF-K · Hervorgehoben

SED-5CYGF-K — Nest-Box Prefilled Syringe Vacuum Filling and Stoppering Machine

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

SED-5CYGF-K nest-box prefilled syringe vacuum filling and stoppering machine — 5 filling heads + 5 stoppering heads. Sterile, high-efficiency automated packaging for prefilled syringes with intelligent inspection. Handle

Lieferzeit
Auf Anfrage
Durchsatz
2550–3450 syringes/hour

Funktionsweise

Under Class A laminar flow protection, an operator tears the film/paper from the nest box; the box is fed onto the conveyor belt to the filling/stoppering machine. At the tooling station an automatic vacuum-cup picker lifts the nest from the box and places it on the filling/stoppering fixture. The fixture indexes to the filling station: 5 high-precision ceramic-plunger pumps — driven independently by 5 Siemens servo systems — fill each syringe through 316L stainless filling needles. Vacuum filling (−50 to −100 kPa) is monitored by a high-precision vacuum sensor and a polished 316L vacuum tank with diaphragm-valve switching. The fixture then indexes to the stoppering station: rubber stoppers fed from the quick-lock 316L vibration pot through the buffer chamber are placed onto syringes via 5 stoppering heads (316L plunger rods + sleeves) under independently controllable vacuum. Aqueous filling uses mechanical stoppering. Sensors detect filling-needle overload and missing-stopper conditions and alarm. After all syringes are filled and stoppered, the suction-cup transfer puts the loaded nest back into the nest box, which the conveyor delivers out. X/Y servo axes (Siemens) handle the 316L stainless central-disk clamping; the disk has an automatic opening device.

Prozessbeschreibung
1Under Class A laminar flow protection, an operator tears the film/paper from the nest box; the box is fed onto the conveyor belt to the filling/stoppering machine.
2At the tooling station an automatic vacuum-cup picker lifts the nest from the box and places it on the filling/stoppering fixture.
3The fixture indexes to the filling station: 5 high-precision ceramic-plunger pumps — driven independently by 5 Siemens servo systems — fill each syringe through 316L stainless filling needles.
4Vacuum filling (−50 to −100 kPa) is monitored by a high-precision vacuum sensor and a polished 316L vacuum tank with diaphragm-valve switching.
5The fixture then indexes to the stoppering station: rubber stoppers fed from the quick-lock 316L vibration pot through the buffer chamber are placed onto syringes via 5 stoppering heads (316L plunger rods + sleeves) under independently controllable vacuum.
6Aqueous filling uses mechanical stoppering.
7Sensors detect filling-needle overload and missing-stopper conditions and alarm.
8After all syringes are filled and stoppered, the suction-cup transfer puts the loaded nest back into the nest box, which the conveyor delivers out.
9X/Y servo axes (Siemens) handle the 316L stainless central-disk clamping; the disk has an automatic opening device.

Technische Daten

Technische Daten für Variante: SED-5CYGF-K

Technische Daten

Modell
SED-5CYGF-K
Durchsatz
2550–3450 syringes/hour
Spannung
380V/50Hz
Konformitätsangaben
Designed and manufactured per GMP (current Good Manufacturing Practice); supplier supports IQ/OQ/PQ/PV (4Q) and SAT validation on-site
Leistung
17 kW
Luftdruck
0.55–0.75 MPa, 40 L/s compressed air

Abmessungen

Länge
2750 mm
Breite
1300 mm
Höhe
1760 mm
Gewicht
3000 kg

Werkstoffe

Kontaktwerkstoffe
316L stainless steel — vibration pot, vibration track, clean piping, central-disk clamp, vacuum chamber, gas/vacuum tank, filling needles, rubber-plug rod, stoppering sleeve, machine wetted parts; ceramic — filling needle high-seal structure and plunger pumps

Wesentliche Merkmale

5 filling heads + 5 stoppering heads on nest-box prefilled syringes
Production 3000 syringes/h
Supports syringe sizes 1 mL Long, 2.25 mL, 3 mL, 5 mL, 10 mL
Ceramic plunger pump filling — high-precision, suits high-viscosity products
Filling accuracy ≤±1.5% (full-servo can hit ±1%)
Filling vacuum −50 to −100 kPa; stoppering vacuum −50 to −100 kPa, independently controlled
Stoppering pass rate ≥99.9%
Filling and plugging vacuum chambers separated (316L SS)
Quick-lock 316L stainless rubber-stopper vibration pot + buffer chamber (refill without opening door)
316L SS clean piping with capsule filter and sanitary diaphragm valve (GEMU)
Polished 316L gas/vacuum tank with vacuum sensor
X/Y high-precision servo center-disk clamping with auto-disk-open device
Siemens HMI, PLC, servo motors throughout
Class A laminar flow hood integrated
Imported brand glove box with self-cleaning station for stoppers
Jog handle for debugging; batch report and recipe storage
Fiber-optic in-position sensing on every motion
Filling-needle overload and missing-stopper sensor alarms
Door-open safety stop on glass isolator window
Standalone or integrated (combined with film-tearing machine)
GMP-compliant manufacturing of pre-filled syringes
All wetted parts in 316L stainless steel
Quick-lock vibration pot — fast tool-less changeover
Independent vacuum control for fill and plug — flexibility per recipe
Full Siemens drive train; Schneider electrics; SMC pneumatics; HIWIN screws/guides; NSK bearings; GEMU diaphragm valves
Optional plunger pump swap supports water-based filling with mechanical stoppering

Anwendungen

Pre-filled syringe vacuum filling and stoppering
Vaccine, ophthalmic, dermal and small-volume parenteral filling
Ointment and aqueous formulations (with appropriate plunger pump)

Branchen

Pharmaceutical (sterile injectables / prefilled syringes)
Biopharmaceutical / Vaccine

Komponentenhersteller

HMI / PLC / servo motor / switching power supply
Siemens
Mini relay / contactor / button / air switch
Schneider
Proximity switch / photoelectric sensor
OMG
Magnetic switch / solenoid valve / cylinder
SMC
Speed-regulating motor / reducer
JSCC
Filling pump (ceramic plunger)
Jingzhuo
Vacuum pump
Becker
Isolator gloves
Rotterdler
Ball screw / linear guide
HIWIN
Pneumatic diaphragm valve
GEMU
High-frequency dynamic pressure transmitter
Xuanye
Bearings
NSK
Plastic bearing
IGUS
Timing belt
Megadyne
Hopper and rail vibrator
Shanghai Puzhuo
SED
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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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