Accueil / Équipements / Ligne de remplissage de liquides à 4 têtes / Liquid Filling Production Line - Vial Wash-Sterilize-Fill-Cap-Inspect-Label Linkage Line
SED-4GZX-J
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SED-4GZX-J
SED · SED-4GZX-J · En vedette
SED-4GZX-J — Liquid Filling Production Line - Vial Wash-Sterilize-Fill-Cap-Inspect-Label Linkage 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
The SED-4GZX-J is a complete vial washing-sterilization-filling-stoppering-capping-labeling linkage line for 5-20 mL tubular glass vials, designed at 6,000 vials/hour for 10 mL vials (350 pcs/min washer throughput). The
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Délai de livraison
Sur devis
Cadence
297.5–402.5 vials/hour (10 ml)
Fonctionnement
Vials enter the SED-80CXP2-J ultrasonic washer for six-stage internal cleaning: recirculating water x2, CA blow, WFI rinse, CA blow, CA blow; external: recirculating water + CA blow. Clean vials transfer to the SED-110RXG-J hot-air tunnel for dry-heat sterilization and depyrogenation at 280-350 degrees C (water-cooled cooling zone). Sterile vials pass under oRABS isolation into the SED-4XGS-J servo filling/stoppering machine where four ceramic-pump heads fill each vial and rubber stoppers are inserted. The SED-20ZG-J crimping/capping machine applies aluminum crimp caps. Capped vials proceed to the SED-GJ-J automated light-inspection station for defect detection, and finally to the SED-BTB-J labeler. Each machine runs servo or VFD drives for synchronized throughput.
Processus de fonctionnement
1Vials enter the SED-80CXP2-J ultrasonic washer for six-stage internal cleaning: recirculating water x2, CA blow, WFI rinse, CA blow, CA blow; external: recirculating water + CA blow.
2Clean vials transfer to the SED-110RXG-J hot-air tunnel for dry-heat sterilization and depyrogenation at 280-350 degrees C (water-cooled cooling zone).
3Sterile vials pass under oRABS isolation into the SED-4XGS-J servo filling/stoppering machine where four ceramic-pump heads fill each vial and rubber stoppers are inserted.
4The SED-20ZG-J crimping/capping machine applies aluminum crimp caps.
5Capped vials proceed to the SED-GJ-J automated light-inspection station for defect detection, and finally to the SED-BTB-J labeler.
6Each machine runs servo or VFD drives for synchronized throughput.
Caractéristiques techniques
Caractéristiques de la variante : SED-80CXP2-J ultrasonic washer (350 pcs/min @10mL
Caractéristiques
Modèle
SED-4GZX-J
Cadence
297.5–402.5 vials/hour (10 ml)
Tension
AC 380V 50Hz (light-inspection station 220V)
Fluides et énergie
Electrical: 380V 50Hz three-phase across the line (220V on light-inspection station). Total installed power roughly 70-75 kW (washer 11 kW + tunnel 47.3 kW + filling 8 kW + capping 2.8 kW + inspection). Compressed air: 0.4-0.6 MPa for washer CA wash stages. WFI (water for injection) for washer final rinse stage. Cooling water for tunnel water-cooled cooling zone.
Détails de conformité
Designed to meet new GMP regulations and manufactured to export standards. Validation documentation (DQ, IQ, OQ, PQ, OM, MM, FAT, SAT) included. oRABS isolation systems on the filling/stoppering station provide enhanced aseptic processing. (PAO)/DOP test ports on tunnel; negative-pressure sealing; real-time temperature curve logging.
Pression d’air
0.4–0.6 MPa compressed air (washer)
Dimensions
Emprise au sol
Approximate footprints: Washer 2280x2200x1450 mm; Sterilization tunnel 2600x1820x2240 mm; Filling/stoppering 2120x2350x2500 mm; Capping 2200x1550x2500 mm; Light-inspection 2200x880x1280 mm; Labeling (TBD). Total line length approx. 12-15 m.
Matériaux
Matériaux en contact
Pharmaceutical-grade stainless steel throughout product-contact zones; SUS304 mesh belts and chamber surfaces; ceramic pumps for filling (SUPER brand); FOUCS sanitary pneumatic diaphragm valves
Matériaux du bâti
Stainless-steel construction across all six machines; toughened-glass oRABS shields on filling and capping stations
Caractéristiques principales
Complete 6-machine linkage line: wash -> sterilize -> fill/stopper -> cap -> inspect -> label
6,000 vials/hour throughput for 10 mL tubular glass vials (5-20 mL range)
Six-stage ultrasonic + WFI + CA internal wash on washer
280-350 degrees C adjustable hot-air dry-heat sterilization tunnel (water-cooled cooling zone)
oRABS isolation system and toughened-glass guards on filling/stoppering station
Servo-controlled ceramic-pump filling (SUPER); 2-10 mL range per pump, 4 heads
Automated light-inspection station with auto reject
Siemens HMI/PLC; Schneider drives, VFDs, contactors; ABB motors; NSK bearings
Validation documentation: DQ, IQ, OQ, PQ, FAT, SAT
Turnkey sterile-injectable line - single-vendor responsibility for six integrated machines
Built to new GMP and export standards for direct deployment in regulated markets
oRABS isolator on filling station for enhanced aseptic protection
Comprehensive validation package (DQ through SAT) included
Premium component brands: Siemens, Schneider, ABB, NSK, FOUCS
Applications
Sterile injectable pharmaceutical filling for tubular glass vials (5-20 mL)
Vaccine, biologic, and lyophilization-precursor liquid filling
Antibiotic and small-molecule injectable production
Veterinary injectable filling
Secteurs
Pharmaceutical (sterile injectables / parenterals)
Biologics and vaccines
Veterinary injectables
Marques des composants
Siemens - HMI and PLC (Germany)
Schneider - VFD, contactors, relays, servo drives + filling servo motors, e-stop (France)
ABB - motors (used on washer)
NSK - bearings
FOUCS - sanitary pneumatic diaphragm valves
SUPER - ceramic pumps
SED
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Conformité
New GMP-compliant
Export standard manufactured (FAT + SAT)
Nettoyage et entretien
All product-contact surfaces are stainless steel suitable for CIP/wipe-down to GMP protocols. The washer continuously self-cleans via its WFI/CA cycle; the sterilization tunnel includes an ultrasonic mesh-belt cleaning device. Filling station surfaces cleaned per GMP SOPs before and after each batch.
Documentation
Fiche technique (PDF)
Aperçu de l’équipement, caractéristiques et dimensions · Document d’origine (anglais)
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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)
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Protocoles FAT / SAT
Essais de réception en usine et sur site · Document d’origine (anglais)
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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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