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SED-4-2YTG-Y

Sur devis

SED-4-2YTG-Y

SED · SED-4-2YTG-Y · En vedette

SED-4-2YTG-Y — High-Speed Vial Liquid Filling and Stoppering Machine

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High-speed (80-100 vpm) vial liquid filling and stoppering machine for 1-5ml vials in Grade A environment. Ceramic-pump filling with one servo per pump and stepper-driven inlet/outlet, synchronous-belt tracking conveyanc

JB/T 20098-2007 antibiotic glass-vial liquid filling production lineGB/T 5226.1-2002 mechanical safety / electrical equipmentGB/T 4272-1992 thermal insulation2015 Chinese Pharmacopoeia2010 GMP and 2015 appendixEU sterilization standard reference

Délai de livraison

Sur devis

Cadence

80–100 vials/min

Fonctionnement

Vials emerge from a depyrogenation tunnel and enter via a divider plate that rejects fallen/abnormal bottles. A star-wheel transfers them to a synchronous-belt tracking conveyor that moves vials at constant velocity. Filling needles track the rising liquid level (anti-foam, anti-splash) while ceramic pumps — one servo motor per pump for accuracy plus stepper-driven inlet/outlet — dispense the precise volume. A star wheel transfers filled vials to the dual-head stoppering station where stoppers from a SUS316L vibratory bowl are placed by a vacuum-driven reciprocating action; head height is adjustable for full or half stoppering. Stoppered vials exit through a star wheel onto a conveyor or a 500mm receiving dial. The whole filling area is enclosed in a Grade A C-RABS isolator with online detection of pressure/wind/particles/humidity/microbiology; opening the door auto-stops the machine.

Processus de fonctionnement

1Vials emerge from a depyrogenation tunnel and enter via a divider plate that rejects fallen/abnormal bottles.

2A star-wheel transfers them to a synchronous-belt tracking conveyor that moves vials at constant velocity.

3Filling needles track the rising liquid level (anti-foam, anti-splash) while ceramic pumps — one servo motor per pump for accuracy plus stepper-driven inlet/outlet — dispense the precise volume.

4A star wheel transfers filled vials to the dual-head stoppering station where stoppers from a SUS316L vibratory bowl are placed by a vacuum-driven reciprocating action; head height is adjustable for full or half stoppering.

5Stoppered vials exit through a star wheel onto a conveyor or a 500mm receiving dial.

6The whole filling area is enclosed in a Grade A C-RABS isolator with online detection of pressure/wind/particles/humidity/microbiology; opening the door auto-stops the machine.

Caractéristiques techniques

Caractéristiques de la variante : SED-4-2YTG-Y

Caractéristiques

Modèle

SED-4-2YTG-Y

Cadence

80–100 vials/min

Tension

380V 50Hz

Détails de conformité

Full validation document set: DQ, IQ, OQ, PQ, FAT, SAT, DQDR; 1-year warranty + lifetime maintenance; 36-hour service response; 48-hour spare parts dispatch.

Puissance

3.5 kW

Dimensions

Longueur

3000 mm

Largeur

1160 mm

Hauteur

1900 mm

Poids

880 kg

Matériaux

Matériaux en contact

316/316L stainless steel (parts in contact with the liquid); SUS316L (stopper vibratory bowl, stopper rail); pharma-grade imported silicone tubing with non-toxic certificate

Matériaux du bâti

SS304 stainless steel base frame and table; SUS304 panels (Ra ≤ 0.4 μm at welded folds); FDA-validated high-density polyoxymethylene (POM) screws and bushings

Caractéristiques principales

Ceramic-pump filling, one servo motor per pump (accuracy ≤1%)

Stepper-controlled inlet/outlet for filling stability

Synchronous-belt tracking conveyance — needles follow liquid level

Dual-head vacuum reciprocating stoppering with full/half-stopper switchable

Grade A C-RABS isolator on filling area with online glove leak detection

Online environmental detection: pressure differential, wind speed, particles, humidity, microbiology

Automatic sampling mode (auto + manual on individual pumps)

Aseptic transfer of stoppers via SUS316L vibratory bowl with pickup sensor (avoids missing stopper)

Horizontal stoppering layout per new GMP

φ900 in-feed turntable with auto reject for fallen vials

Torque limiters on main shaft and star wheels (auto-stop on jam, breakage <0.05%)

316L SS contact parts; FDA-grade POM screws and bushings

Stainless-steel base frame; touchscreen counter; 3-level password

Variable-frequency drive everywhere — quick star-wheel changeover

Imported pharma-grade silicone tubing with non-toxic certificate

Distributor surface roughness Ra ≤ 0.4 μm

Stoppering qualified rate ≥99%

No-bottle-no-stopper rate 100%

No-bottle-no-fill rate 100%

Filling accuracy ≤1%

Bottle breakage <0.05%

Noise ≤70 dB

Vacuum pump suction 50 m³/h

Compliant with 2015 Chinese Pharmacopoeia, 2010 GMP, JB/T 20098-2007, GB/T 5226.1-2002, EU sterilization standards, WHO, USP, IEC, CE

Comprehensive validation package (DQ/IQ/OQ/PQ/FAT/SAT/DQDR)

36-hour service response; 48-hour spare parts dispatch; 1-year warranty + lifetime maintenance

Applications

1-5ml antibiotic / liquid injectable vial filling and stoppering

Aseptic Grade A vial dosing

Secteurs

Pharmaceutical injectables

Antibiotic / biopharmaceutical aseptic fill-finish

Marques des composants

PLC system (NX70 series)

Mitsubishi

Servo drives and motors

Mitsubishi / Delta

Inverter (22F-D2P5N103)

Mitsubishi

HMI (2711C-T10C)

Mitsubishi

Peristaltic pump (R520)

Spirax Sarco

Bearings (UCF/UCPH206/IR151916)

NSK

Coupling and torque limiter

Miki Pulley

Linear guide / linear bearing

Igus

Synchronous belt (672-8M-30)

BRECO-BELT

Proximity switch / mid-relay

Omron

Photoelectric switch / reflective fiber

Autonics

Switching power supply

Delta

Miniature circuit breaker / contactor / E-stop

Schneider

Vibratory feeder (450 stoppers/min)

Shanghai Jingmi

SED

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Conformité

JB/T 20098-2007 antibiotic glass-vial liquid filling production line

GB/T 5226.1-2002 mechanical safety / electrical equipment

GB/T 4272-1992 thermal insulation

2015 Chinese Pharmacopoeia

2010 GMP and 2015 appendix

EU sterilization standard reference

WHO guidance reference

USP environmental and safety

ISO / IEC compliance

CE compliance

Nettoyage et entretien

Filling area operates under Grade A C-RABS isolator; stopper vibratory bowl and rail made of SUS316L; all product-contact silicone tubing imported with non-toxic certificate; distributor surface Ra ≤ 0.4 μm for cleanability.