GLX Model Vial Injection Washing-Drying-Filling-Stoppering-Capping Production Line

Xin Weisheng

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GLX Model Vial Injection Washing-Drying-Filling-Stoppering-Capping Production Line
GLX Model Vial Injection Washing-Drying-Filling-Stoppering-Capping Production Line
OVERVIEW
The GLX model vial injection washing-drying-filling-stoppering-capping production line is composed of the QCL series vertical ultrasonic washing machine, ASMR series depyrogenation tunnel, KGF series vial injection filling and stoppering machine, and KGL series capping machine whilst the individual machine can also be used independently. Suitable for production of vial injection of 2-30ml, it can complete more than 20 work procedures such as ultrasonic bathing, three-time WFI and recycled water washing, three-time compressed air flushing, exterior wall water washing and compressed air flushing, preheating, drying, sterilizing, depyrogenation, cooling, pre-fill gas purging, filling, post-fill gas purging, stoppering and capping.

The whole processing line adopts PLC control, frequency converter and HMI control technology to make the production process stable and reliable. The touch screen can display running dynamics of each single machine, with water pressure, air pressure and temperature to be shown at each control point. The display of each on-off status and faults, fault self-diagnosis, fault analysis and eliminating ways will realize the automatic control for the whole production process. The production line is provided with the automatic three-machine balancing control device to ensure the even and reliable production.
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FEATURES

The vial washing machine adopts the mechanical arms to clamp the vials in various specifications;

The water-gas spray nozzles adopt the reciprocating tracking insertion mode for vial washing, featured by excellent washing effect and energy saving. It is also provided with a device that prevents the nozzle holder from shaking to enhance the accuracy of the spray nozzle's insertion into the vials and reduce the occurrence of nozzle breakage;

The water and gas pipes are totally separable from the spray nozzles, so that cross contamination is avoided and cGMP requirements are met;

The buffer block is installed before the vial out-feed scroll of the vial washing machine to protect the scroll and reduce vial breakage;

Vial out-feed is realized by the integral imported synchronous belt that is connected to the vial pushing block to convey ampoules, a structure that ensures stable and reliable transmission;

The depyrogenation tunnel adopts the hot air circulation heating method with even temperature and energy saving;

The depyrogenation tunnel is provided with the function of protecting against sudden power-off to ensure safe running;

The depyrogenation tunnel can be equipped with the water cooling device that does not consume air volume in the room, whilst reducing the risk of unbalanced differential pressure in the room and achieve good cooling effect;

The depyrogenation tunnel can be equipped with the differential pressure automatic balancing and regulating system to eliminate the issues of deviation at the high temperature section caused by unbalanced differential pressure in the room and tunnel, and the temperature rise in the filling room and washing-drying room;

The depyrogenation tunnel is provided with the PAO inspection ports (including inspection ports for air pressure, air speed and dust particles);

The cooling section in the tunnel is provided with the sterilization function (specially chosen by FDA);

The depyrogenation tunnel mesh belt can be equipped with the ultrasonic and CIP cleaning systems;

The depyrogenation tunnel chamber can be subject to all-round, multi-angle high pressure water washing;

The filling machine adopts the horizontal synchronous belt for vial transmission with high speed, accurate vial separation and convenient change-over of the format parts;

The conveying plane where the vial is positioned has a certain distance to the work bench to make the class 100 air flow easy to go pass smoothly, and to avoid the drug to be polluted by the turbulent air flow;

The stoppering part of the filling machine adopts the horizontal stopper feeding and plate suction systems, featured by convenient observation, easy material feeding and high stopper feeding speed;

The filling machine can be equipped with the ceramic pump, piston pump or peristaltic pump;

The filling machine is provided with the functions of no bottle no filling and no bottle no stoppering;

The filling machine can be equipped with the servo filling system.

OPTIONAL ADD-ONS
According to customer requirements, it can also be equipped with the following:

Control system of brands such as Siemens, Schneider, Allen Bradley, Mitsubishi and Delta;

Online particle counting, alarm system, recording and printing systems;

ORABS, CRABS, or aseptic isolator system.

TECHNICAL PARAMETERS
Product Model QCL60+ASMR620/35+KGF4 QCL60+ASMR620/43+KGF6 QCL60+ASMR620/43+KGF8 QCL80+ASMR620/48+KGF10 QCL120+ASMR800/55+KGF12 QCL120+ASMR1250/60+KGF20 QCL80*2+ASMR1250/60+KGF12*2
Applicable Specifications (ml)
(GB standard vial)
2-25
Number of Filling Heads 4 6 8 10 12 20 24
Production Capacity (pcs/min) 120 (2ml) 180 (2ml) 200 (2ml) 300 (2ml) 400 (2ml) 500 (2ml) 650 (2ml)
Qualified Rate of Bottle Washing (%) ≥99
Breakage Rate of Washing (%) ≤0.1
Sterilization Temperature (°C) 300-500
Exhaust Air (m2/h) 3,000 4,100 7,500 8,000-10,000
Flling Accuracy (%) ≤±2.5 (Mechanical control of fling pump)
≤±0.5-1.0 (Servo contro of fling pump)
Qualifed Rate of Stoppering (%) ≥99
Cleanliness of Laminar Air (Class) 100
Speed of Vacuum Pumping (m3/h) 10 30 50 60 60 100 120
Capacitance (kw) 66.6 75.6 106.6 212.6 232.6
Power supply 385V/50Hz
Total weight (kg) 6,300 6,300 7,900 9,400 10,900 14,600
Dimension (LxWxH) (mm) 8,550 × 2,540 × 2,330 9,620 × 2,540 × 2,330 10,280 × 3,230 × 2,360 12,730 × 2,600 × 2,620 11,790 × 5,700 × 2,620
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