Biotech Powder Filling Machine for Vials

Q: What is the filling accuracy and production capacity of the machine?

The machine delivers a filling accuracy of ±2% to ±3% (depending on powder characteristics and bulk density). APF 12S (Single Track) : Up to 100 vials per minute APF 12D (Double Track) : Up to 200 vials per minute It supports fill volumes from 50 mg to 10 grams per vial (single or multiple dosing) and handles vial sizes from 5 ml to 250 ml .

Q: How does the machine ensure sterility and minimize contamination?

Sterility is maintained through: Operation under optional inbuilt Laminar Air Flow (Class 100 / ISO 5) “No Vial – No Fill” system Immediate built-in rubber stoppering after filling SS316L contact parts that are easily removable for autoclaving/sterilization Vacuum-pressure dosing with minimal human intervention and optional sampling/rejection systems.

Description

Biotech Powder Filling Machine for Vials is a high-precision, automated system designed for filling fine powders into small-volume vials used in biotechnology and pharmaceutical applications. Engineered for sterile and aseptic environments, it handles sensitive biological powders such as lyophilized biologics, vaccines, APIs, and cell/gene therapy compounds. The machine ensures accurate dosing, minimal contamination, and compliance with stringent regulatory standards. It supports small-scale R&D, clinical trials, and high-speed commercial production, with output rates ranging from 30 to 400 vials per minute depending on configuration.

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Salient Features of Biotech Powder Filling Machine for Vials

Compact GMP Model.
Filling Accuracy of ± 2% depending upon powder characteristics and environmental conditions.
Powder wheel rotation and vial transportation through servo motors.
Vacuum driven specially designed Powder Wheels.
All contact parts made of SS316L materials with easy removal system for Autoclaving / Sterilization.
Tool Less adjustment of Doctor Blade and Wiper Blade saves valuable time and easy for setting.
Built in Turn Tables with Separate Drive for speed control of infeed and outfeed of vials, Built in Rubber Stoppering System.

Suitable to fill 50mg to 1500mg in single dosing.
Multiple dosing system with the help of change parts.
Various safety features including Clutch system for Vial Breakage.
IQ/OQ Validation documentation can be provided.
PLC system with Graphical User Interface can be offered.
Inbuilt Laminar Air Flow can be offered for sterile class 100 filling.
Sampling and Rejection system can be provided on demand.

Working Principle of Biotech Powder Filling Machine for Vials

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 twelve ports which rotates at 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 into 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.

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 container is passed between two pressing roller for tight fit fixing of rubber stoppers.

Technical Specification of Biotech Powder Filling Machine for Vials

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 Powder Filling Machines

Antibiotic Powder Filling Machine

Injectable Powder Filling Machine

Auger Powder Filling Machine

Bottle Dry Injectable Filling Machine

Automatic Dry Syrup Powder Filling Machine

Dry Syrup Powder Filler Capper

Dry Syrup Powder Filling Machine

Double Head Auger Powder Filling Machine

Applications of Powder Filling Machines

Advantages of Biotech Powder Filling Machine for Vials

High Filling Accuracy and Consistency

Enhanced Sterility and Contamination Control

Reduced Product Waste and Cost Savings

Increased Efficiency and High Throughput

Regulatory Compliance and Validation Ease

Key Features of Biotech Powder Filling Machine for Vials

High-Accuracy Dosing: Employs servo-driven auger fillers, gravimetric weigh cells, or vacuum-pressure dosing for precise filling. Ideal for high-potency or low-dose biotech powders.

Aseptic Processing: Integrates isolators, RABS, or laminar flow hoods with HEPA filtration for ISO Class 5 cleanroom compatibility. Supports Sterilization-in-Place (SIP) and Cleaning-in-Place (CIP) for contamination-free operation.

Vial Compatibility: Handles glass or plastic vials, with quick-change tooling for different sizes/formats, including pre-sterilized or ready-to-use (RTU) vials.

In-Process Control (IPC): Real-time weight verification with automatic rejection of non-compliant vials, ensuring 100% quality control and minimal product loss.

Flexible Integration: Operates standalone or in-line with vial washing, depyrogenation, stoppering, and capping systems. Modular design allows seamless scalability.

Advanced Controls: Touchscreen HMI with recipe storage for rapid changeovers. Includes dust extraction, vibration, or stirring mechanisms to manage cohesive or poorly flowing powders.

Regulatory Compliance: Fully compliant with cGMP, FDA, and EU standards, offering data logging and audit trails for traceability.

FAQ for Biotech Powder Filling Machine for Vials

What is a Biotech Powder Filling Machine for Vials?

The Biotech Powder Filling Machine for Vials is a high-precision, aseptic filling system designed for accurate dosing of sterile biological powders (such as lyophilized biologics, vaccines, antibiotics, and cell/gene therapy compounds) into glass or plastic vials. It uses a vacuum-pressure powder wheel system with servo controls, built-in rubber stoppering, and operates under Class 100 laminar airflow to ensure sterility and compliance with cGMP, USFDA, and WHO standards.

What is the filling accuracy and production capacity of the machine?

The machine delivers a filling accuracy of ±2% to ±3% (depending on powder characteristics and bulk density).

APF 12S (Single Track): Up to 100 vials per minute
APF 12D (Double Track): Up to 200 vials per minute It supports fill volumes from 50 mg to 10 grams per vial (single or multiple dosing) and handles vial sizes from 5 ml to 250 ml.

Which types of powders and vials can this machine handle?

It is ideal for free-flowing to slightly cohesive sterile injectable powders used in biotech and pharmaceutical applications. The agitated hopper and vacuum-pressure system maintain uniform density. The machine works with a wide range of round glass or plastic vials (5 ml to 250 ml) and offers quick changeover with minimal change parts.

How does the machine ensure sterility and minimize contamination?

Sterility is maintained through:

Operation under optional inbuilt Laminar Air Flow (Class 100 / ISO 5)
“No Vial – No Fill” system
Immediate built-in rubber stoppering after filling
SS316L contact parts that are easily removable for autoclaving/sterilization
Vacuum-pressure dosing with minimal human intervention and optional sampling/rejection systems.

What are the key advantages and optional features available?

Key advantages include high accuracy, reduced product waste, regulatory compliance (IQ/OQ documentation), easy changeover, and compact GMP design. Optional features include:

PLC with HMI and recipe management
Servo-driven systems
In-process check weighing
Dust extraction and nitrogen flushing
Integration with complete vial washing, depyrogenation, and capping lines.

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