Sterile Powder Filling and Rubber Stoppering Machine

A 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 Video

The process typically involves:

• Powder Filling: Sterile powder is dosed into vials using vacuum-pressure or servo-driven systems, with options for single or dual hoppers for accuracy.

• Rubber Stoppering: Pre-sterilized rubber stoppers are fed via vibratory bowls and inserted using pick-and-place or roller-based mechanisms, often with verification for proper placement.

• Sterility Features: All contact parts are made from stainless steel (SS 316), autoclavable, and easy to disassemble for cleaning. Machines may include nitrogen flushing to displace oxygen and prevent oxidation.

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.

Applications

• Primary Use: Filling sterile powders for injectables in pharmaceutical, biotech, and veterinary industries.

• Industries: Pharma production lines, especially for dry powder injectables where sterility is critical to prevent microbial contamination.

• Customization: Can handle micro-doses or high volumes; integrable with upstream (vial washing) and downstream (cap sealing, labeling) equipment for full aseptic lines.

Salient Features of Sterile Powder Filler 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 Vial Powder 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 Sterile 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.