Pharmaceutical Dry Injection Filling Machine

Pharmaceutical Dry Injection Filling Machine

A Pharmaceutical Dry Injection Filling Machine is specialized equipment used for the aseptic filling of sterile dry powders, such as antibiotics, vaccines, or other active pharmaceutical ingredients (APIs), into vials, ampoules, or syringes for injectable use. Dry Injection Filling Machine are designed to ensure precise dosing, maintain sterility, and comply with current Good Manufacturing Practices (cGMP) for parenteral drug production. They are critical in pharmaceutical manufacturing for producing dry powder injections that are later reconstituted with a solvent before administration.

Pharmaceutical Dry Injection Filling Machine Video

Key Features

  • Aseptic Processing: Operates in cleanroom environments with laminar airflow or Restricted Access Barrier Systems to prevent contamination.

  • Precision Dosing: Utilizes volumetric, gravimetric, or vacuum-pressure systems to achieve accurate fill weights, often with 100% in-process control.

  • Containment: Incorporates isolators or barrier systems to protect operators from potent/toxic powders and prevent cross-contamination.

  • High Throughput: Capable of filling 60–450 vials per minute (VPM), depending on the machine’s configuration.

  • Integrated Functions: Combines filling, stoppering, and capping in a single monobloc system for efficiency.

  • Sterilization: Features in-line sterilization and compatibility with pre-sterilized containers.

  • Automation: Includes real-time weight checks, rejection systems for defective vials, and data logging for regulatory compliance.

Working Principle

  1. Powder Loading: Sterile powder is loaded into a hopper with agitators to ensure uniform flow and prevent clumping.

  2. Container Handling: Pre-sterilized vials or ampoules are fed via a conveyor or rotary wheel into the filling station.

  3. Dosing: Powder is dispensed using:

    • Volumetric Systems: Adjustable cavities or augers for consistent volume.

    • Gravimetric Systems: Weight-based dosing with real-time feedback.

    • Vacuum-Pressure Systems: For precise filling of fine or sticky powders.

  4. Stoppering/Capping: Rubber stoppers are placed, and vials are sealed under sterile conditions.

  5. Inspection: Automated checks for fill accuracy, container integrity, and sterility; defective units are rejected.

  6. Output: Filled and sealed vials are collected for labeling, packaging, or further processing.

Applications

  • Filling sterile powders for antibiotics, oncology drugs, or vaccines.

  • Suitable for small to large-scale production in pharmaceutical plants.

  • Used for high-potency APIs requiring containment and low-dose precision.

Salient Features of Dry Injection Filling Machine

  • Compact cGMP model.

  • “No Vial, No Filling” system eliminates wastage of costly powder.

  • Multiple Dosing System.

  • High Volumetric Filling Accuracy of ±2% of uniform density Injectable powder can be ensured by setting the depth of piston in the port of powder wheel.

  • Built-in Rubber Stoppering Unit saves lot of space in the Sterile Area & reduces the length of Laminar Flow.

  • Individual drive for the filling & sealing to match the speed of filling & sealing.

  • All motors are provided with appropriate contractors and relays for the protection against any overload or jamming.

  • Safety clutch system to avoid Vial breakage.

  • Variable AC Frequency Drive for speed adjustment.

  • All contact parts are easily removable for mandatory Autoclaving/ Sterilization.

  • Digital counter for counting production output.

Working Principle of Dry Injection 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 eight ports rotates at the 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 in to 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. (Different grooves separator can be used which depends on the container diameter or multiple dosing systems). 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 the container is passed between two pressing roller for tight fit fixing of rubber stopper.

Technical Specification of Dry Injection Filler Machine

Models APF 12S APF 12D
Production Output Up to 100 vials/minute Up to 200 vials/minute
Fill Volume 50 mg. to 10grams 50 mg. to 10 grams
Vial Size 5ml to 250ml 5ml to 250ml
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.


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