GMP Vial Powder Filling Machine

Q: What are the power requirements and key features of the GMP Vial Powder Filling Machine?

Power requirements are model-specific: Single Track : 3.5 HP Double Track : 4.5 HP (Voltage is customizable as per your country’s requirements, typically 440 Volts, 3 Phase, 50 Hz.) Key features include: Compact cGMP model with built-in stoppering Variable AC frequency drive for speed control Digital production counter Agitated powder hopper for uniform bulk density Safety clutch to prevent vial breakage Easy integration with vial washing, depyrogenation, capping, and labeling machines for a complete production line.

Description

GMP Vial Powder Filling Machine is a specialized piece of equipment designed for the precise, sterile filling of powder-based pharmaceuticals (such as injectables, antibiotics, or lyophilized drugs) into glass or plastic vials. It ensures compliance with Good Manufacturing Practice (GMP) standards, which are regulatory guidelines enforced by bodies like the FDA and EMA to guarantee product quality, safety, and sterility in pharmaceutical production. These machines are essential in aseptic environments to minimize contamination risks, maintain dosage accuracy, and support high-volume output for industries like biotech, cosmetics, and sterile injectables. Primary Use: Ideal for sterile powder injectables like vaccines, insulin, or antibiotics in pharmaceutical and biopharma settings. Can be standalone or part of automated lines including washing, depyrogenation, capping, and labeling.

Infeed and Preparation: Vials are fed via turntables with independent drives for controlled speed. Pre-sterilized powder is loaded into the hopper and agitated for consistency.

Filling: The powder wheel rotates under vacuum, metering exact doses into vials. Accuracy is typically ±1-2%, depending on powder properties like flowability or humidity.

Stoppering: Built-in system partially or fully inserts rubber stoppers immediately after filling to maintain sterility.

Outfeed and Integration: Filled and stoppered vials exit to downstream equipment like capping, labeling, or sealing machines, forming a complete vial filling line.

Salient Features of GMP Vial Powder Filling Machine

Built-in Rubber Stoppering Unit saves lot of space in the Sterile Area & reduces the length of Laminar Flow.
“No Vial, No Filling” system eliminates wastage of costly powder.
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.
All motors are provided with appropriate contractors and relays for the protection against any overload or jamming.
All contact parts are easily removable for mandatory Autoclaving/ Sterilization.

Multiple Dosing System.
Compact cGMP model.
Individual drive for the filling & sealing to match the speed of filling & sealing.
Safety clutch system to avoid Vial breakage.
Variable AC Frequency Drive for speed adjustment.
Digital counter for counting production output.

Working Principle of GMP Vial Powder 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 GMP Vial Powder Filling 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.

Types of Vial Filling Machine

Automatic Vial Filling Machine

High Speed Vial Filling Machine

Vial Liquid Filling Machine

Vial Powder Filling Machine

Automatic Vial Filling and Rubber Stoppering Machine

Lab Scale Vial Filling Stoppering & Cap Sealing Machine

Injectable Vial Powder Filling & Stoppering Machine

Peristaltic Pump based Vial Filling Machine

Applications of Vial Filling Machine

Advantages of GMP Vial Powder Filling Machine

Reduces human error and contamination risks compared to manual filling

Boosts efficiency (e.g., 30–100 VPM with minimal waste)

Supports batch decontamination via VPHP

It’s versatile for R&D-scale (low output) or commercial production (high speed)

Easy scalability for different formulations

Key Components of GMP Vial Powder Filling Machine

Construction and Compliance: Built with stainless steel (SS316) contact parts for corrosion resistance and easy sterilization via autoclaving. Designed as a monobloc (compact) unit that integrates filling and rubber stoppering/bunging on a single platform, fully meeting GMP, ISO, and EU Annex 1 requirements for cleanroom operations.

Filling Mechanism: Utilizes a vacuum-driven powder wheel or auger system for accurate dosing. Powder is stored in an agitated hopper to ensure uniform bulk density, preventing settling or clumping. Servo-driven controls allow for tool-less adjustments, such as doctor and wiper blades, enabling quick changeovers between products or vial sizes.

Automation and Controls: Often equipped with PLC systems featuring graphical user interfaces for recipe management, speed control, and real-time monitoring. Optional features include laminar airflow integration, sampling/rejection systems, and IQ/OQ validation documentation for regulatory audits.

Safety Features: Includes clutch mechanisms to handle vial breakage without halting production, overload protection, and emergency stops. Supports integration with isolators or RABS for enhanced operator and product protection, especially with toxic formulations.

FAQ for GMP Vial Powder Filling Machine

What is a GMP Vial Powder Filling Machine and what does it do?

The GMP Vial Powder Filling Machine is a fully automatic, cGMP-compliant monoblock system designed to accurately fill sterile dry powders into glass vials and immediately apply rubber stoppers. It is specially built for injectable antibiotics, vaccines, and lyophilized products. The machine uses a vacuum-pressure powder wheel system with an agitated hopper for precise dosing, ensuring high sterility, minimal contamination, and full compliance with cGMP, USFDA, and WHO guidelines.

What is the production capacity of the GMP Vial Powder Filling Machine?

Our GMP Vial Powder Filling Machine is available in two models:

Single Track: Up to 100 vials per minute
Double Track: Up to 200 vials per minute

The actual output depends on vial size, powder characteristics, fill weight (50 mg to 10 grams), and bulk density. It delivers reliable high-speed performance for medium to large-scale sterile powder production.

Which vial sizes and fill weights can the GMP Vial Powder Filling Machine handle?

The machine supports a wide range of vial sizes from 5ml to 250ml. It can accurately fill powder doses from 50 mg to 10 grams per vial (single or multiple dosing). Changeover between different vial sizes is quick with minimum change parts, making it highly flexible for pharmaceutical manufacturers producing various powder injectable products.

How does the GMP Vial Powder Filling Machine ensure sterility and compliance?

The machine is designed with strict GMP standards in mind:

All product contact parts are made of SS 316L and are easily removable for autoclaving/sterilization.
“No Vial – No Filling” system prevents powder wastage and contamination.
Built-in rubber stoppering unit reduces exposure time and laminar airflow area.
Operates under Class 100 Laminar Air Flow with optional isolator/RABS compatibility.
Safety clutch, agitated hopper, and easy-clean design support easy validation (IQ/OQ).

This ensures maximum sterility and full regulatory compliance for sterile powder filling.

What are the power requirements and key features of the GMP Vial Powder Filling Machine?

Power requirements are model-specific:

Single Track: 3.5 HP
Double Track: 4.5 HP

(Voltage is customizable as per your country’s requirements, typically 440 Volts, 3 Phase, 50 Hz.)

Key features include:

Compact cGMP model with built-in stoppering
Variable AC frequency drive for speed control
Digital production counter
Agitated powder hopper for uniform bulk density
Safety clutch to prevent vial breakage
Easy integration with vial washing, depyrogenation, capping, and labeling machines for a complete production line.

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