Showroom à Ontario, Californie · Assistance à confirmer pour votre destination
Accueil / Équipements / Remplisseuse de poudre et boucheuse de flacons / Vial Filling, Rubber-Stopper Insertion and Crimping Integrated Machine (Online Weighing)
SED-1FGX-3
Sur devis
SED-1FGX-3
SED · SED-1FGX-3 · En vedette

SED-1FGX-3 — Vial Filling, Rubber-Stopper Insertion and Crimping Integrated Machine

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

SED-1FGX-3 is an integrated vial filling + stopper-insertion + crimping machine with online weight checking for the sterile-powder vial line. New-generation high-speed online-weighing electromagnetic vibratory filler. Li

GMPIEC-61131 (PLC programming)21 CFR Part 11 (computer system, optional)GAMP 5 (automated control system, optional)Class-100 local laminar flow within Class-100,000 cleanroom
Choisir une variante (2)
Délai de livraison
Sur devis
Cadence
15 flacons/min

Fonctionnement

Vial infeed platform (with light inspection + tempered-glass surface) → vibratory bottle unscrambler seats plastic/glass vials into synchronous-belt carrier modules (2 or more vials per module) → synchronous belt carries vials to the filling station → microprocessor auto-calculates and controls electromagnetic vibration frequency to dispense powder via transition funnel into vials → balance weighs filled vials (undersized fill sent to dedicated reclaim hopper) → synchronous belt carries vials to stopper-insertion station → gripper picks up rubber stopper and inserts into bottle mouth (missing-stopper auto-rejection) → carry to crimping station → crimped vials conveyed to next process. Full operation under Class-100 H14 laminar-flow filter.

Processus de fonctionnement
1Vial infeed platform (with light inspection + tempered-glass surface) → vibratory bottle unscrambler seats plastic/glass vials into synchronous-belt carrier modules (2 or more vials per module) → synchronous belt carries vials to the filling station → microprocessor auto-calculates and controls electromagnetic vibration frequency to dispense powder via transition funnel into vials → balance weighs filled vials (undersized fill sent to dedicated reclaim hopper) → synchronous belt carries vials to stopper-insertion station → gripper picks up rubber stopper and inserts into bottle mouth (missing-stopper auto-rejection) → carry to crimping station → crimped vials conveyed to next process.
2Full operation under Class-100 H14 laminar-flow filter.

Caractéristiques techniques

Caractéristiques de la variante : SED-1FGX-3 integrated filling + stopper-insertion + crimping machine

Caractéristiques

Modèle
SED-1FGX-3
Cadence
15 flacons/min
Tension
380V
Fluides et énergie
Power: 380 V; total machine power ~18 kW. Clean compressed air: 0.4–0.6 MPa, ~1–2 m³/h (cylinder drive). Vacuum source: -6×10⁻² MPa, 20–50 L/min (customer supply). HEPA exhaust, vial washer, oven — customer supply.
Détails de conformité
Complies with GMP; PLC programming compliant with IEC-61131; computer/electronic systems compliant with 21 CFR Part 11; automated control compliant with GAMP 5; Class-100 laminar flow (H14 HEPA, ≥0.45 m/s). Customer to provide: vial washer, oven interlayer exhaust fan (HEPA exhaust box if required), vacuum source, compressed air and other utilities.
Puissance
18 kW
Pression d’air
0.4-0.6 MPa (clean compressed air, ~1-2 m³/h for cylinders)

Dimensions

Poids
2500 kg

Caractéristiques principales

Fill + stopper-insertion + crimping all-in-one integrated machine
Electromagnetic vibratory dosing + online weighing
Compatible bottle sizes: 10–100 ml vials
Compatible stoppers: standard rubber stoppers, full-compression rubber stoppers
Design throughput: 10 ml vial / 1.0–2.0 g fill ≥15 vials/min
Stable throughput: ≥10 vials/min
Fill range: 0.5–2.5 g
Fill variation: ±1% at 1.0–2.0 mg fill
Bottle breakage rate: ≤0.05%
Stopper-insertion failure rate detection: ≥99.5%
Missing-stopper auto-rejection (sensor): ≥99.5%
Integrated Class-100 laminar flow: H14 HEPA filter, air velocity ≥0.45 m/s
In-line vacuum sampling/rejection: -6×10⁻² MPa, 20–50 L/min
Noise at 1 m: ≤70 dBA
Automatic production counting display
PLC programming compliant with IEC-61131
Optional: 21 CFR Part 11 + GAMP 5 compliant (with central computer storage/recording)
Fill + stopper + crimp three-in-one — saves floor space and process steps
Electromagnetic vibratory dosing + online weighing dual redundancy: fill accuracy ±1%
Integrated Class-100 laminar flow for aseptic filling
Ultra-low bottle breakage rate (≤0.05%)
Compliant with IEC-61131 / 21 CFR Part 11 / GAMP 5 (pharma regulatory)
Includes 10 ml tooling as standard
Media-fill option (peristaltic pump, optional)

Applications

10–100 ml vial sterile powder filling
Antibiotic sterile powder-for-injection dispensing
Sterile lyophilised vial filling + stoppered + crimping
Media-fill validation (optional peristaltic pump)

Secteurs

Pharmaceutique
Sterile preparations
Biopharmaceutical
SED
Échangez avec SED Sales Team
Spécialistes des équipements · contact sur WhatsApp
Consultez les horaires et la disponibilité de l’équipe

Conformité

GMP
IEC-61131 (PLC programming)
21 CFR Part 11 (computer system, optional)
GAMP 5 (automated control system, optional)
Class-100 local laminar flow within Class-100,000 cleanroom

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)
Demander au service commercial
Fiche comparative (Standard et Économique)
Comparaison des configurations · Document d’origine (anglais)
Demander au service commercial
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)
Demander au service commercial
Certificats d’étalonnage
Niveau sonore, résistance de terre, rigidité diélectrique et rugosité · Document d’origine (anglais)
Demander au service commercial
DQ (qualification de la conception)
Protocole complet de qualification de la conception · Document d’origine (anglais)
Demander au service commercial
Certificats matières
Composition de l’acier inoxydable 316L · Document d’origine (anglais)
Demander au service commercial
SED
WhatsApp · Ventes SED
Contact commercial · WhatsApp
→