Parenterals Vial Powder Filling Machine

Description

Parenterals Vial Powder Filling Machine are specialized pharmaceutical equipment designed for the aseptic filling of sterile dry powders into glass or plastic vials used for injectable drugs. These machines ensure precise dosing, minimize contamination risks, and comply with cGMP standards, including operations in cleanroom environments. They typically integrate filling, stoppering (bunging), and sometimes capping in a monoblock setup to maintain sterility and efficiency. Vial Powder Filling Machine are essential for small-volume parenterals (SVPs), handling vials from 2 ml to 50 ml, and are used in high-value biopharma production where accuracy is critical to avoid product loss.

Infeed: Sterilized vials are fed via turntables or star wheels into the machine at controlled speeds.

Powder Dosing: Powder from a hopper is drawn into dosing wheels (vacuum-assisted) and dispensed into vials. Servo motors adjust for precision.

Weighing/IPC: Each vial is weighed in real-time; non-conforming units are rejected.

Stoppering: Rubber stoppers are partially inserted (bunged) under sterile conditions.

Outfeed: Vials exit for capping, labeling, or further processing (e.g., lyophilization).

Cleaning: Contact parts (SS316) are autoclavable; the system supports CIP/SIP cycles.

This process operates at speeds from 60–450 vials per minute (VPM), with higher outputs for medium-to-large batches.

If you need details on specific models, pricing, or comparisons with multi-head machines, let me know!

Salient Features of Parenterals Vial Powder Filling Machine

Filling range typically from 50 mg. to 10grams (or more) ± 2 – 3% in single dosing depending upon consistency.
Fully automatic operation with Programmable Logic Controller (PLC) and user-friendly color HMI.
Output ranging Up to 100 vials to 200+/minute (depending on model and number of filling heads).
Built-in stoppering unit with vacuum or mechanical pick-and-place for reliable stopper placement.

Effective dust extraction and containment system to prevent cross-contamination and protect operators.
“No Vial – No Fill” and “No Vial – Machine Stop” systems to avoid powder wastage.
Safety clutch to prevent vial breakage and overload protection.
Suitable for a wide range of vial sizes with minimal change parts.

Working Principle of Parenterals 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 Parenterals 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 Parenterals Vial Powder Filling Machine

High Filling Accuracy and Consistency

Enhanced Production Speed and Throughput

Superior Sterility and Reduced Contamination Risk

Minimal Product Waste and Cost Savings

Gentle and Reliable Powder Handling

Improved Quality Control and Regulatory Compliance

Key Features of Parenterals Vial Powder Filling Machine

Common features across models include:

Filling Mechanism: Vacuum or servo-driven powder wheels for volumetric dosing, achieving accuracy of ±2%. Agitators in the powder hopper maintain uniform bulk density.

Stoppering System: Built-in rubber stopper insertion under laminar airflow for sterility.

In-Process Control (IPC): 100% weighing and rejection of under/over-filled vials to prevent waste.

Safety and Flexibility: Clutch systems for vial breakage protection, tool-less adjustments, multiple dosing via change parts, and optional PLC interfaces with GUI for automation.

Containment: Modular designs for RABS or isolators, with inbuilt laminar airflow for Class 100 filling zones.

FAQ for Parenterals Vial Powder Filling Machine

What is a Parenterals Vial Powder Filling Machine?

A Parenterals Vial Powder Filling Machine is a fully automatic aseptic filling system designed for precise dosing of sterile dry powders into glass vials, followed by rubber stoppering and aluminum sealing. It is specially built for pharmaceutical production of injectable powder formulations such as antibiotics (penicillin, cephalosporins), vaccines, oncology drugs, and other lyophilized parenterals. The machine ensures high accuracy, sterility, and compliance with cGMP and FDA standards.

What are the main advantages of a Parenterals Vial Powder Filling Machine?

Key advantages include:

Excellent fill weight accuracy (±1% to ±2%) with minimal powder wastage
High production speed (60 to 400+ vials per minute)
Superior sterility assurance through dust containment and reduced human intervention
Gentle handling of sensitive sterile powders to preserve potency and stability
Quick changeover for different vial sizes and fill weights
Full regulatory compliance with cGMP, FDA, and EU Annex 1

It is ideal for high-value and potent injectable powders.

How does a Parenterals Vial Powder Filling Machine ensure accurate dosing and sterility?

The machine uses advanced dosing technologies such as vacuum-pressure powder wheels, servo-controlled augers, or dosing discs for consistent fill weights. It operates in an ISO Class 5 / Grade A environment with RABS or isolator compatibility. Features like effective dust extraction systems, SS316L product contact parts, “No Vial – No Fill” interlock, and automatic rejection help maintain sterility and prevent cross-contamination throughout the filling, stoppering, and sealing process.

What is the typical production capacity and accuracy of a Parenterals Vial Powder Filling Machine?

Production capacity typically ranges from 60 to 120 vials per minute in standard models and can reach 200–400+ vials per minute in high-speed multi-head configurations. Fill weight accuracy is generally ±1% to ±2%, depending on powder flow properties and fill volume (usually 50 mg to 30 g or more). The exact output depends on vial size (2 ml to 100 ml), powder characteristics, and machine configuration.

Why choose a Parenterals Vial Powder Filling Machine for sterile powder injectables?

Sterile powder injectables (especially antibiotics and lyophilized products) require special handling to avoid moisture exposure and maintain long-term stability. A Parenterals Vial Powder Filling Machine is designed specifically for dry powder dosing with dust control and gentle filling mechanisms, unlike liquid vial fillers. It provides better product integrity, lower contamination risk, and higher efficiency for moisture-sensitive or heat-labile powders that cannot be filled in liquid form.

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