Sterile Powder Filling and Rubber Stoppering Machine is a specialized piece of pharmaceutical packaging equipment designed for the aseptic filling of sterile dry powders into glass vials, followed by immediate sealing with rubber stoppers. These machines ensure compliance with Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards by maintaining a sterile environment, often integrated with laminar airflow hoods (LAF), HEPA filters, and isolator systems. They are essential in the production of injectable powders, reducing contamination risks and enabling high-speed, precise operations.
Sterile Powder Filling and Rubber Stoppering Machine are monobloc (compact, single-unit designs) or part of integrated lines that include vial washing, sterilization, capping, and labeling.
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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.
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.
Designed as a monobloc unit for aseptic filling and stoppering in a single compact platform, ideal for cleanroom environments.
Achieves ±2% accuracy (depending on powder characteristics and uniform bulk density). Precise dosing is controlled by piston depth in the powder wheel ports.
Eliminates wastage of costly sterile powder by ensuring filling occurs only when a vial is present.
Integrated stoppering saves valuable space in the sterile area, reduces the length of laminar airflow hood, and minimizes vial exposure time for superior sterility.
Powder hopper equipped with mechanical agitators maintains consistent bulk density. Vacuum suction and compressed/nitrogen gas flushing ensure accurate and gentle powder transfer.
High-grade stainless steel (SS316L) contact parts with easy tool-less removal for autoclaving and sterilization. Framework in SS304.
Separate drives allow synchronized speed matching between filling and stoppering operations for smooth, high-speed performance.
Adjustable speed control for optimal production rates (up to 100–200 vials/min depending on model).
Safety clutch system to prevent vial breakage, overload protection on motors, and reliable mechanical systems.
Supports single or multiple dosing for a wide fill range (50 mg to 10 grams or more).
All contact parts are easily removable. Tool-less doctor blade and wiper blade adjustments. Designed for quick changeover and minimal downtime.
Built-in counter for accurate batch tracking and output monitoring.
PLC with HMI and Graphical User Interface
Inbuilt Laminar Air Flow (Class 100)
IQ/OQ documentation support
Check-weighing and rejection systems
The machine offers a high volumetric filling accuracy of ±2% to ±3% (depending on powder bulk density uniformity and environmental conditions).
It supports fill volumes from 50 mg to 10 grams (with multiple dosing options) and handles vial sizes from 5 ml to 250 ml.
Sterilized powder in the hopper is agitated for uniform bulk density. A vacuum-driven powder wheel with pistons draws precise powder volumes. Excess powder is removed by a doctor blade, and compressed air or nitrogen flushes the dose into the vial. Filled vials then move immediately to the built-in stoppering unit, where pre-sterilized rubber stoppers are picked from a vibratory bowl and firmly pressed using timing belts and rollers — all under controlled sterile conditions.
It is ideal for sterile injectable powders such as antibiotics, vaccines, high-potency APIs, and lyophilized products. The machine handles both free-flowing and cohesive powders effectively in controlled cleanroom environments (Class 100). It ensures compliance with USFDA, WHO, and cGMP standards, making it suitable for pharmaceutical and biotech manufacturers.
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Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.
Adinath International manufactures high-precision vial powder filling machines and complete packaging lines, providing reliable, hygienic, and efficient solutions for global pharmaceutical industries.
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