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SED-1-400BRG-Q
Sur devis
SED-1-400BRG-Q
SED · SED-1-400BRG-Q · En vedette

SED-1-400BRG-Q — Semi-Automatic IV Soft-Bag Filling and Sealing 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

The SED-1-400BRG-Q is a semi-automatic IV soft-bag (single/dual-chamber) filling and sealing machine. Single-operator, one bag per cycle. Compatible with single-chamber bags (100-1000 ml single-tube, 100-1000 ml dual-tub

GMP compliantCE certifiedFDA 21 CFR Part 11 compliant software (audit trail, multi-level access control)
Délai de livraison
Sur devis
Cadence
200–400 bags/hour

Fonctionnement

Single-cycle sequence: manual bag loading → pneumatic gripper bag transfer → vacuum → precise volumetric filling via Endress+Hauser Coriolis mass flow meters and pneumatic diaphragm valves → nitrogen flush → stopper insertion → output. CIP is controlled by timed valve open/close sequences. SIP is achieved by measuring effective sterilisation temperature and time. All product-contact piping is sterilisable in-place at 121°C.

Processus de fonctionnement
1Single-cycle sequence: manual bag loading → pneumatic gripper bag transfer → vacuum → precise volumetric filling via Endress+Hauser Coriolis mass flow meters and pneumatic diaphragm valves → nitrogen flush → stopper insertion → output.
2CIP is controlled by timed valve open/close sequences.
3SIP is achieved by measuring effective sterilisation temperature and time.
4All product-contact piping is sterilisable in-place at 121°C.

Caractéristiques techniques

Caractéristiques de la variante : SED-1-400BRG-Q

Caractéristiques

Modèle
SED-1-400BRG-Q
Cadence
200–400 bags/hour
Tension
220V ±10%, 50Hz
Fluides et énergie
Power: 220V ±10%, 50Hz, 8 kW (including laminar flow); Compressed air: 800 L/min @ 0.65-0.8 MPa, dry oil-free; Pharmaceutical N2: per process requirements; Liquid feed pressure: 0.3-0.6 MPa (foam-free filling at 0.4 MPa). Background cleanroom: Grade C or B. Temperature: 0-45°C; RH <65%. Noise: <75 dB at 1 m.
Détails de conformité
GMP compliant; CE certified; software complies with FDA 21 CFR Part 11. Meets infusion-bag production legal requirements. Price includes VAT, packaging, and domestic freight (excludes warehousing, port handling, and unloading). Payment: 50% pre-payment, 50% on shipment. Lead time: 6 months from contract signing + deposit receipt. Free remote support within 1 year. Operating language: Chinese and English.
Puissance
8 kW
Pression d’air
Compressed air 0.65-0.8 MPa (800 L/min, dry, oil-free); filling pressure 0.4 MPa for foam-free product; product liquid 0.3-0.6 MPa

Dimensions

Longueur
3000 mm
Largeur
1600 mm
Hauteur
2400 mm
Poids
1000 kg
Emprise au sol
L 3000 x W 1600 x H 1800 mm (without laminar flow); H 2400 mm with laminar flow. Final footprint per contract drawings (varies with bag specification).

Matériaux

Matériaux en contact
SS316 (product pipework, filling heads, all product-contact parts); medical silicone rubber; steam-sterilisable at 121°C
Matériaux du bâti
SS304 frame and guarding; high-transparency acrylic (PMMA) viewing panels

Caractéristiques principales

Single-operator semi-automatic cycle: load → vacuum → fill → N2 flush → stopper → output
Two independent filling systems for dual-chamber bags (two different liquids simultaneously)
Pre-filling vacuum + post-filling nitrogen flush
Includes Class 100 Orabs laminar flow + glovebox integrated protection
Built-in CIP/SIP: all product-contact piping sterilisable at 121°C in-place
Compatible with single and dual-chamber soft bags; bag width up to 300 mm, length ≤350 mm
Filling accuracy: 100-250 ml ±3 g; >250 ml ±1% (E+H Coriolis mass flow meters)
Output: 200-400 bags/hour (at filling pressure 0.4 MPa, foam-free product)
GMP and CE compliant; meets infusion-bag production regulatory requirements
Complete Orabs + laminar flow + glovebox solution included
High-precision E+H Coriolis mass flow meters — 100-250 ml ±3 g; >250 ml ±1%
Full CIP/SIP capability — reduces contamination risk, simplifies batch changeover
Compact semi-automatic footprint for IV bag production
Key brands: Siemens PLC; SMC cylinders/valves; E+H flow meters

Applications

Single-chamber IV soft-bag filling (100-1000 ml, single or dual tube)
Single-chamber IV soft-bag filling 2000/3000 ml (non-PVC, dual tube)
Dual-chamber bag filling (two different liquids, total ≤3000 ml)
Sterile IV bag production with laminar flow + glovebox protection

Secteurs

Pharmaceutical manufacturing (parenteral / IV solutions)
Infusion bag production

Marques des composants

PLC: Siemens
Cylinders and valves: SMC
Sensors: SMC, Keyence
Circuit breakers: Schneider
Diaphragm valves: SED / Gemu
Mass flow meters: Endress+Hauser (E+H) Coriolis mass flow meters
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Conformité

GMP compliant
CE certified
FDA 21 CFR Part 11 compliant software (audit trail, multi-level access control)

Nettoyage et entretien

Built-in CIP/SIP. CIP controlled by valve open/close timing sequences. SIP via measured effective sterilisation temperature and time. All product-contact piping sterilisable at 121°C in-place. Product-contact materials are corrosion-resistant and ageing-resistant.

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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