Accueil / Équipements / Ligne de remplissage de liquides à 8 têtes / Ligne de remplissage de liquides
SED-8-8-4GZX-J
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SED · SED-8-8-4GZX-J · En vedette
SED-8-8-4GZX-J — Ligne de remplissage de liquides
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-8-8-4GZX-J is a high-speed vial washing-sterilizing-filling-stoppering-capping linkage line for 5 mL (2R) vials at 200 pcs/min (12,000 pcs/hour), built to new GMP and export standards. It comprises: SED-80CXP1-J
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Délai de livraison
Sur devis
Cadence
297.5–402.5 /(pcs/hour) for 5 ml vial
Fonctionnement
5 mL vials are unpacked, washed by ultrasonic + circulating water + WFI + compressed-air rinse in the washer (600–1,000 W ultrasonic, filter integrity test point), then dried and sterilized in the hot-air tunnel (280–350°C, real-time temperature curve recording, cooling-zone SIP). Sterile vials are conveyed under laminar flow to the filling/stoppering machine where 8 servo-controlled ceramic pumps dispense to ±1% accuracy under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system (≥99.99% stoppering success rate). Stoppered vials pass to the capper where aluminum caps are applied and crimped under another oRABS unit with glove ports and door-open shutdown.
Processus de fonctionnement
15 mL vials are unpacked, washed by ultrasonic + circulating water + WFI + compressed-air rinse in the washer (600–1,000 W ultrasonic, filter integrity test point), then dried and sterilized in the hot-air tunnel (280–350°C, real-time temperature curve recording, cooling-zone SIP).
2Sterile vials are conveyed under laminar flow to the filling/stoppering machine where 8 servo-controlled ceramic pumps dispense to ±1% accuracy under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system (≥99.99% stoppering success rate).
3Stoppered vials pass to the capper where aluminum caps are applied and crimped under another oRABS unit with glove ports and door-open shutdown.
Caractéristiques techniques
Caractéristiques de la variante : SED-80CXP1-J ultrasonic washer (350 pcs/min at 5 mL
Caractéristiques
Modèle
SED-8-8-4GZX-J
Cadence
297.5–402.5 /(pcs/hour) for 5 ml vial
Tension
380V, 50Hz
Fluides et énergie
Power: 380V/50Hz. Compressed air: 0.4–0.6 MPa, 45–50 m³/h. WFI: 0.3–0.5 MPa, 40–60°C, 0.6–0.8 m³/h. Circulating water: 0.3–0.5 MPa. Cooling water for tunnel cooling section. Saturated steam for SIP. Customer to provide forklift/crane and labor for installation.
Détails de conformité
Designed and manufactured to new GMP and export standards. Validation documentation (DQ, DS, CCA, IQ, OQ, PQ, OM, MM, FAT, SAT) included with the line.
Pression d’air
0.4-0.6 MPa (compressed air)
Dimensions
Emprise au sol
Multi-station line: washer 2280×2200 mm; tunnel 3600×1820 mm; filler 3650×2350 mm; capper 2200×1550 mm. Conveyors between stations priced per meter (finalized after layout drawing approval). Transfer-table height FL+950 mm throughout.
Matériaux
Matériaux en contact
Product-contact piping in pharmaceutical-grade stainless steel; ceramic pumps for product filling; sanitary FOUCS pneumatic diaphragm valves on product lines
Matériaux du bâti
Pharmaceutical-grade stainless steel construction throughout
Caractéristiques principales
Complete linkage line: ultrasonic washing + hot-air sterilization + servo filling + stoppering + capping
Capacity: 200 pcs/min (12,000 pcs/hour) for 5 mL (2R) vials, one mold set included
Designed to new GMP requirements; manufactured to export standards
Ultrasonic washer: online display/alarm/recording for water/air pressure and temperature; filter integrity test point; isochronous equivalent function
Sterilization tunnel: cooling-zone SIP; glass-scrap collection; real-time temperature curve recording and printing; dehumidification and night-shift modes; 280–350°C range
8 servo-controlled ceramic-pump filling stations: filling accuracy ±1%; stoppering success ≥99.99%
oRABS isolation with FFU, toughened-glass guard, glove ports and door-open shutdown on filling and capping stations
Capping qualification rate ≥99.9%; vial breakage <0.05%; noise <70 dB
Full validation documentation (DQ, DS, CCA, IQ, OQ, PQ, OM, MM, FAT, SAT) + 20-day installation/commissioning service
High-speed 12,000 pcs/h line dedicated to 5 mL vial format
Ceramic-pump filling for excellent accuracy and durability with sterile liquids
oRABS isolators on filling and capping stations for sterile-manufacturing assurance
Cooling-zone SIP in the tunnel for enhanced aseptic operation
Premium component mix: Schneider/NSK/THK/IGUS/Camfil/ABB
Applications
High-speed sterile filling of 5 mL vials
Vaccine filling
Small-volume parenterals and biologics
Antibiotic powder/liquid vial filling
Secteurs
Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing
Marques des composants
HMI/PLC/VFD/contactors/relays/servo drive: Schneider (France)
Filling servo motors: Schneider (France)
Optical fibers and amplifiers: Panasonic (Japan)
Bearings: NSK (Japan); CAM bearings: THK (Japan); slide/flange bearings: IGUS (Germany)
Main motors: ABB (USA)
Reducer: Jinggeng (Shanghai); deceleration motor: Taiqi (Shanghai); planetary reducer: Hanxing (Hubei)
Centrifugal pump: CNP (Hangzhou)
Air cylinders, solenoid valves, FRL: Air-tac (Taiwan)
Proximity switches: Contrinex (Switzerland)
Pneumatic diaphragm valves: FOUCS
Heat-resistant filters: Camfil (Sweden); HEPA: SUJING (Suzhou)
Synchronous belts: Megadyne (Italy); ball screws: HIWIN (Taiwan)
Ceramic pump: Jingzhuo (Shenzhen) / Super (Wuxi)
Ultrasonic generator: Dewei (Zhangjiagang)
Gloves: North (USA)
SED
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Conformité
Designed to new GMP requirements (China)
Manufactured to export standards
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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