Injectable Powder Filling and Stoppering Machine

An Injectable Powder Filling and Stoppering Machine is a specialized piece of pharmaceutical equipment designed for the aseptic filling of sterile dry powders into glass vials, followed by the immediate application of rubber stoppers to seal the vials. These machines are critical in the production of injectable drugs, ensuring precision, sterility, and compliance with cGMP standards. They are typically monobloc designs that integrate filling and stoppering on the same platform to minimize contamination risks, often operating under laminar airflow or isolator systems.

Injectable Powder Filling and Stoppering Machine are widely used in pharmaceutical manufacturing for vials ranging from 2 ml to 100 ml, with fill volumes from 50 mg to 6 g. They handle round vials and support multiple dosing without part changes.

Injectable Powder Filling and Stoppering Machine Video

Key Features and Components

Modern machines incorporate advanced features for efficiency, safety, and accuracy:

• Filling Mechanism: Vacuum-pressure or servo-driven powder wheels dose powder using compressed air or nitrogen flushes. Accuracy is typically ±1–2% depending on powder density and humidity.

• Stoppering System: Vibratory bowl feeders supply rubber stoppers, inserted via rollers or chutes for half or full bunging.

• Safety and Controls: “No Vial, No Fill” and “No Stopper, No Run” sensors prevent waste; AC frequency drives for speed control; PLC with HMI for automation.

• Materials: All contact parts are SS 316L for autoclaving; non-contact parts in SS 304.

• Additional Options: Pre/post-gassing (nitrogen), HEPA filtration, RABS/isolator compatibility, and integration with washing, sealing, or labeling lines.

Working Principle

1. Vial Infeed: Empty sterilized vials enter via turntable or slat conveyor.

2. Powder Filling: Vials are indexed under the powder wheel. Vacuum draws powder into ports, then air pressure ejects it into the vial. Separators ensure upright positioning.

3. Stoppering: Filled vials move to the stoppering station, where a vibrator feeds stoppers into a chute. Rollers press them securely.

4. Outfeed: Sealed vials exit for capping/sealing. The entire process is continuous, with output up to 400 vials per minute (VPM).

Environmental controls are essential to prevent powder clumping.

Salient Features of Injectable Powder 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 Injectable Powder Filling Filler

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 Injectable Powder Filling Machine

* 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.