Aseptic Powder Filling Machine (injectable powder filler) including Sterile powder filling machine is cGMP machine designed to fill powder injection vials. Sterile Powder Filler is the monobloc machine which can do filling and stoppering/bunging operations on same platform. All contact parts are made from Stainless Steel 316L or FDA approved materials for cGMP compliance.
Injectable Powder Filling Machine available in Single Powder Wheel and Double Powder Wheel models variants which provide production output ranging from 60 VPM to 200 VPM. Vacuum driven powder wheel with special design to achieve higher filling accuracy. We also offer Vial Cap Sealing Machine and Vial Labeling Machine which makes complete automatic Vial Powder Filling Line.
Salient Features of Aseptic Filling Machine
- Compact GMP Model.
- Suitable to fill 50mg to 1500mg in single dosing.
- Powder wheel rotation and vial transportation through servo motors.
- Vacuum driven specially designed Powder Wheels.
- All contact parts made of SS316L materials with easy removal system for Autoclaving / Sterilization.
- Filling Accuracy of ± 2% depending upon powdwer characteristics and environmental conditions.
- Built in Rubber Stoppering System.
- Multiple dosing system with the help of change parts.
- Built in Turn Tables with Separate Drive for speed control of infeed and outfeed of vials.
- Various safety features including Clutch system for Vial Breakage.
- Tool Less adjustment of Doctor Blade and Wiper Blade saves valuable time and easy for setting.
- IQ/OQ documentation can be provided.
- PLC system with Graphical User Interface can be offered.
- Inbuilt Laminar Air Flow can be offered for sterile class 100 filling.
- Sampling and Rejection system can be provided on demand.
Working Principle of Aseptic Filling Machine
The sterilized powder is stored in powder hopper is agitated by pair of mechanical agitators for maintaining consistency and uniform bulk density. The powder wheel having twelve ports which rotates at pre-determined speed below the powder hopper with practically no clearance. Powder wheel consist of Piston in each port and behind the powder wheel vacuum plate is provided. There is no clearance between powder wheel and vacuum plate due to back spring pressure. Precise volume of powder is sucked into the port of powder wheel during vacuum; according to the piston length different fill size can be achieved. The excess powder is doctored off by a doctor blade. Doctor blades can be adjusted from outside also without removing powder hopper. When powder wheel indexes further and remain in the port due to the vacuum till it reaches just vertically above the container. The time dose of Compressed air (Nitrogen Gas), sterilized low pressure air sequentially flushes out powder from the port of powder wheel in to the container one by one.
The filled containers are immediately separated on the conveyor by vial separator and moves further for stoppering operation.
The sterilized, siliconised, rubber stoppers stored in the vibrator bowl moves to vibratory bowl and stacked vertically in the rubber stopper chute. The container is hold firmly between pair or timing belt to pickup rubber stopper from exit end of the chute. Further container is passed between two pressing roller for tight fit fixing of rubber stoppers.
Technical Specification of Aseptic Filling Machine
|Models||APF 12S||APF 12D|
|Production Output||Up to 100 vials/minute||Up to 200 vials/minute|
|Fill Volume||50 mg. to 1200 mg in single dosing||50 mg. to 1200 mg in single dosing|
|Vial Size||5ml to 100ml||5ml to 100ml|
|Filling Accuracy||± 2 – 3% in single dosing depending upon consistency and uniformity of bulk density of Injectable Powder||± 2 – 3% in single dosing depending upon consistency and uniformity of bulk density of Injectable Powder|
|Power Load||3.5 H. P.||4.5 H. P.|
|Overall Dimension||2600mm (L) X 1100mm (W) X 1800mm (H) approx.||3000mm (L) X 1100mm (W) X 1800mm (H) approx.|
|Net Weight||500 kgs. approx.||700 kgs. approx.|
|Gross Weight||750 kgs. approx.||950 kgs. approx.|
* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.