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SED-6-10GZX-J
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SED-6-10GZX-J
SED · SED-6-10GZX-J · En vedette

SED-6-10GZX-J — Vial Washing, Sterilizing, Filling, Stoppering and Capping 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-6-10GZX-J is a complete vial washing-sterilizing-filling-stoppering-capping linkage line designed for 100 mL vials at 3,000 pcs/hour, built to new GMP requirements and export standards. The line consists of an SE

Designed to new GMP requirements (China)Manufactured to export standards
Choisir une variante (4)
Délai de livraison
Sur devis
Cadence
2975–4025 /(pcs/hour) for 100 ml vial

Fonctionnement

Vials are unpacked and fed into the ultrasonic washer (cycle water rinse × 2 → WFI rinse → compressed air purge cycles). Washed vials enter the hot-air sterilization tunnel (mesh belt 100–400 mm/min, 280–350°C, water-cooled exit zone, real-time temperature curve recording). Sterilized vials transfer to the servo filling-stoppering machine where 6 servo-controlled peristaltic pumps fill under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system. Stoppered vials then enter the capping machine under a second oRABS isolator with aluminum cap feeder and scrap collection. Transfer table height FL+950 mm throughout.

Processus de fonctionnement
1Vials are unpacked and fed into the ultrasonic washer (cycle water rinse × 2 → WFI rinse → compressed air purge cycles).
2Washed vials enter the hot-air sterilization tunnel (mesh belt 100–400 mm/min, 280–350°C, water-cooled exit zone, real-time temperature curve recording).
3Sterilized vials transfer to the servo filling-stoppering machine where 6 servo-controlled peristaltic pumps fill under an oRABS isolator with FFU; rubber stoppers are fed through a two-stage buffer system.
4Stoppered vials then enter the capping machine under a second oRABS isolator with aluminum cap feeder and scrap collection.
5Transfer table height FL+950 mm throughout.

Caractéristiques techniques

Caractéristiques de la variante : SED-40CXP-J ultrasonic washer (3

Caractéristiques

Modèle
SED-6-10GZX-J
Cadence
2975–4025 /(pcs/hour) for 100 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, 0.4–0.5 m³/h. Circulating water 0.3–0.5 MPa. Cooling water for tunnel cooling section. 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. Main equipment footprints: washer 2280×2200 mm, tunnel 6500×2220 mm, filler 4120×1680 mm, capper 2200×1550 mm. Transfer table height FL+950 mm throughout. Inter-machine conveyors priced per meter after layout confirmation.

Matériaux

Matériaux en contact
Product-contact piping in 316L stainless steel (pharmaceutical grade); peristaltic-pump tubing for filling; sanitary pneumatic diaphragm valves (FOUCS) on product lines

Caractéristiques principales

Complete linkage line: washing + sterilization + filling + stoppering + capping
Capacity: 3,000 pcs/hour for 100 mL vials (one specification mold set included)
Designed to new GMP requirements; manufactured to export standards
Ultrasonic washer SED-40CXP-J: online display/alarm/record for water pressure, air pressure and temperature; filter integrity test point; automatic plexiglass cover lifting; ultrasonic 600–1,000 W adjustable
Sterilization tunnel SED-80RXG-J: water-cooled cooling zone; real-time printable temperature curve; PAO/DOP test point; dehumidification and night-shift modes; 280–350°C adjustable
Servo filling-stoppering SED-6XGS-J: 6 servo-controlled peristaltic pumps, ±1% accuracy; no-bottle-no-fill; oRABS with FFU; toughened glass guard; glove ports; door-open shutdown
Capping machine SED-ZG-J: bottle arranging table; inverted-bottle auto-rejection; no-bottle-no-cap; oRABS with FFU; aluminum scrap collector; door-open shutdown
Stoppering success rate ≥99.99%; capping qualified rate ≥99.9%; vial breakage rate <0.01–0.05%
Full validation documentation (DQ/DS/CCA/IQ/OQ/PQ/OM/MM/FAT/SAT) included
20-day on-site installation and commissioning service included
Turn-key vial line for 100 mL format with one mold set included
Built to new GMP and export standards with full Schneider/Siemens-class controls
oRABS isolators on filling and capping for sterile assurance
Premium component brands: Schneider, NSK, THK, IGUS, Camfil, ABB, Panasonic
Validation documentation (DQ through SAT) included in the offer

Applications

Sterile vial filling for liquid injectables
Pharmaceutical small-volume parenterals (100 mL format)
Vaccines, biologics and other aseptic liquid products

Secteurs

Pharmaceutical (sterile injectables)
Biopharmaceutical
Vaccine manufacturing

Marques des composants

HMI / PLC / VFD / contactors / relays
Schneider
Optical fibers and amplifiers
Panasonic
Bearings
NSK
CAM bearings
THK
Slide / flange bearings
IGUS
Main motors
ABB
Reducer (washer / tunnel)
Jinggeng
Deceleration motors
Taiqi
Centrifugal pump
CNP
Air cylinders / solenoid valves / FRL
Airtac
Proximity switches
Contrinex
Pneumatic diaphragm valves
FOUCS
Heat-resistant HEPA filters (tunnel)
Camfil
HEPA filters (FFU)
SUJING
Servo drive and motor (filling)
Schneider
Planetary reducer (filling servo)
Hanxing
Synchronous belts
Megadyne
Ball screws
HIWIN
Peristaltic pump
Signal
Ultrasonic generator
Dewei
Stainless steel mesh belt (washer/tunnel)
Shenwang
FFU fan (isolators)
Duoyili
FFU HEPA filter (isolators)
Huatai
Gloves (isolators)
Snow Lotus
Capping machine main motor
Deli
Capping reducer
TQG
Paper recorder (tunnel)
Meacon
Solid state relay (tunnel)
SHIMADEN
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)
Demander au service commercial
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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