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Accueil / Équipements / Ligne d’isolateurs de remplissage aseptique de flacons / Vial Aseptic Filling Isolator Production Line
SED-50XWGX-A
Sur devis
SED-50XWGX-A Vial Aseptic Filling Isolator Production Line
SED · SED-50XWGX-A · En vedette

SED-50XWGX-A — Vial Aseptic Filling Isolator Production Line

La description complète de ce modèle est encore en cours de traduction. Consultez les détails en anglais ou demandez des informations à notre équipe. English

Small-batch R&D and pilot-scale vial aseptic filling line with isolator. Integrated system combining aseptic isolator, in-line liquid filling machine, stoppering machine, and multifunctional capping/sealing machine. Perf

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Délai de livraison
Sur devis
Cadence
20–50 flacons/min

Fonctionnement

After sterilization, vials enter the star-wheel conveying system and are transferred to the conveyor by small star wheels. Vials move at constant speed on a synchronous belt into the filling station, where the filling needle rack doses the liquid into each vial. Filled vials pass through the volume inspection/sampling station; acceptable vials proceed to the stoppering station for full or half stoppering. Stoppered vials then pass to the crimping machine for aluminum-cap crimp-sealing. The entire process is completed in a Grade A environment; opening an isolation door triggers automatic shutdown.

Processus de fonctionnement
1After sterilization, vials enter the star-wheel conveying system and are transferred to the conveyor by small star wheels.
2Vials move at constant speed on a synchronous belt into the filling station, where the filling needle rack doses the liquid into each vial.
3Filled vials pass through the volume inspection/sampling station; acceptable vials proceed to the stoppering station for full or half stoppering.
4Stoppered vials then pass to the crimping machine for aluminum-cap crimp-sealing.
5The entire process is completed in a Grade A environment; opening an isolation door triggers automatic shutdown.

Caractéristiques techniques

Caractéristiques de la variante : Filling/stoppering machine: capacity 20–50 vials/minute

Caractéristiques

Modèle
SED-50XWGX-A
Cadence
20–50 flacons/min
Tension
AC380V±10% 50Hz
Fluides et énergie
AC 380 V ±10%, 50 Hz; insulation resistance >1 MΩ with proper grounding
Détails de conformité
GMP Grade A environment; CRABS Grade 1 isolator protection system. Cleanroom classification C-grade or 100,000-class; temperature 18–28°C; relative humidity 50–65%; filling and sealing zone Grade 100; operating zone air velocity 0.25–0.45 m/s
Puissance
5 kW

Dimensions

Longueur
4600 mm
Largeur
1100 mm
Hauteur
2380 mm
Poids
730 kg

Matériaux

Matériaux en contact
AISI 304 acier inoxydable; AISI 316 acier inoxydable; 316L stainless steel (filling needles, liquid dividers); FDA-approved materials
Matériaux du bâti
45# painted steel frame (Baosteel); 304 stainless steel guard panels; imported PC Grade-100 laminar-flow guard (8 mm)

Caractéristiques principales

CRABS Grade 1 isolator aseptic protection system
Aseptic filling in Grade A environment; automatic shutdown on door opening
PLC control + touchscreen operation, programmable production
No-vial no-fill function
Centralized lubrication system
Buffer device between single machines for stable inline connection
Filling accuracy ±1% (plunger pump); ±3% (glass mechanical pump)
Stoppering rate ≥99%; capping rate ≥99%; crimp qualification rate ≥99.5%
Vial breakage rate ≤0.1% (filling); ≤0.2% (crimping)
Servo motor driven filling pump; independent servo steering
Electromagnetic oscillating stopper feeder; pneumatic stoppering
Interchangeable capping heads (screw/crimp); adapts to plastic or aluminum caps
Adjustable cap head height for different bottle heights
Air speed, particle, viable/non-viable particle monitoring
Aseptic gloves and integrity testing system
Bottle-tip rejection function; aluminum chip collection/capture device
Fiber-optic crimp counter for automated yield tracking
High-quality AISI 304/AISI 316 stainless steel and FDA-approved contact materials
Purpose-built for small-batch R&D and pilot production; flexibly meets lab and trial manufacturing needs
Three major modules (filling/stoppering, capping/sealing, crimping) operable independently
Complies with GMP Grade A environment requirements
PU synchronous belt + large-modulus gear drive for safe, long-life transmission
Equal-velocity curved cam tracking; filling needle never contacts inner vial wall
Laminar flow frame circular design eliminates sanitary dead angles

Applications

Aseptic filling of 2–5 ml vials
Aseptic filling of 20 ml vials
Biologics filling
Liquid pharmaceutical filling
Pre-lyophilization filling and stoppering

Secteurs

Pharmaceutique
Biopharmaceutical
Vaccine
Injectable drugs

Marques des composants

PLC
Delta
Touchscreen
Delta
Inverter
Delta
Intermediate relay
Omron
Solid-state relay
Omron
Inductive proximity switch
Autonics
Main power switch
Meanwell
Frame
Baosteel
Guard panels
Foshan
Bearings
Igus/NSK/Harbin Bearing
Mesh belt motor
Shanghai
Crimping machine PLC
Siemens
Crimping machine touchscreen
Siemens
Crimping machine inverter
ABB
Crimping machine main switch
Schneider
SED
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Documentation

Fiche technique (PDF)
Aperçu de l’équipement, caractéristiques et dimensions · Document d’origine (anglais)
Demander au service commercial
Manuel opérateur
Installation, fonctionnement et dépannage · Document d’origine (anglais)
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Fiche comparative (Standard et Économique)
Comparaison des configurations · Document d’origine (anglais)
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Protocoles IQ / OQ / PQ
Documentation de validation pour la conformité GMP · Document d’origine (anglais)
Demander au service commercial
Protocoles FAT / SAT
Essais de réception en usine et sur site · Document d’origine (anglais)
Demander au service commercial
Plans CAD (STEP / IGES / DWG)
Plans d’ingénierie pour l’implantation · Document d’origine (anglais)
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Certificats d’étalonnage
Niveau sonore, résistance de terre, rigidité diélectrique et rugosité · Document d’origine (anglais)
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DQ (qualification de la conception)
Protocole complet de qualification de la conception · Document d’origine (anglais)
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Certificats matières
Composition de l’acier inoxydable 316L · Document d’origine (anglais)
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