Dry Injectable Filling Machine

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

The machine is available in two models: APF 12S (Single Head) : Up to 100 vials per minute APF 12D (Double Head) : Up to 200 vials per minute Fill volume ranges from 50 mg to 10 grams (up to 1500 mg in single dosing, higher with multiple dosing via change parts). Filling accuracy is ±2% to ±3% , depending on powder characteristics, bulk density uniformity, and environmental conditions (controlled humidity).

Description

Dry Injectable Filling Machine also known as an Injectable Dry Powder Filling Machine or Vial Powder Filler is a specialized piece of equipment primarily used in the pharmaceutical industry for the aseptic filling of sterile dry powder formulations into vials or ampoules. These machines are essential for producing injectable medications that are moisture-sensitive or require reconstitution with a solvent just before administration, such as antibiotics, vaccines, or other lyophilized powders. The design ensures high precision, sterility, and compliance with cGMP standards to prevent contamination and maintain product stability.

The process is automated and occurs in a monobloc setup to minimize handling and contamination risks:

Vial Feeding: Empty sterile vials are fed via a conveyor belt or turntable into the machine.

Powder Filling: A servo-driven or vacuum-assisted powder wheel rotates to meter and dispense the powder into each vial. This ensures volumetric accuracy using pistons or augers.

Stoppering/Sealing: Rubber stoppers are automatically pressed into place or capped, often under laminar airflow with HEPA filters.

Output: Filled and sealed vials exit for further processes like labeling or inspection. The entire operation is often enclosed in an isolator or RABS for sterility.

Advanced models include pre-cleaning with Water for Injection (WFI), dry heat sterilization tunnels, and integration with inspection systems for quality control.

If you need details on specific models and pricing, let me know!

Salient Features of Dry Injectable Filling Machine

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 Dry Injectable 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 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 Dry Injectable 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 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 Dry Injectable Filling Machine

Excellent Filling Accuracy & Consistency

High Production Capacity

Superior Sterility & Contamination Control

Effective Handling of Challenging Powders

Improved Product Stability & Regulatory Compliance

Key Features of Dry Injectable Filling Machine

Primary Function: Accurately dispenses precise doses of dry powder into glass vials under controlled sterile conditions, followed by rubber stoppering or sealing to ensure airtight closure.

Common Uses:
- Filling beta-lactam antibiotics, acyclovir, or spray-freeze-dried pellets that cannot be stored as ready-to-use liquids due to instability.
- Suitable for pharmaceuticals, cosmetics, biologics, and multi-dose formulations in crystalline or excipient-blended forms.

Why Dry Powder? : This format is cost-effective compared to direct lyophilization, requiring less energy and infrastructure while preserving drug efficacy.

FAQ for Dry Injectable Filling Machine

What is a Dry Injectable Filling Machine and how does it work?

A Dry Injectable Filling Machine is a monobloc aseptic system used in the pharmaceutical industry to fill sterile dry powders into vials. It uses a vacuum-driven powder wheel with pistons: sterilized powder is agitated in the hopper for uniform density, sucked into the wheel ports via vacuum, excess is doctored off, and then flushed into vials using compressed or nitrogen gas. Filled vials are immediately stoppered with rubber bungs to maintain sterility. The compact monobloc design minimizes contamination risks.

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

The machine is available in two models:

APF 12S (Single Head): Up to 100 vials per minute
APF 12D (Double Head): Up to 200 vials per minute

Fill volume ranges from 50 mg to 10 grams (up to 1500 mg in single dosing, higher with multiple dosing via change parts). Filling accuracy is ±2% to ±3%, depending on powder characteristics, bulk density uniformity, and environmental conditions (controlled humidity).

What types of vials and powders can it handle?

It is designed for sterile dry powder injectables such as antibiotics, vaccines, and moisture-sensitive formulations. Compatible vial sizes range from 5ml to 250ml. The vacuum-driven system excels with challenging powders that have poor flow properties. All product contact parts are SS316L for easy sterilization and strict aseptic compliance.

What are the key features of the Dry Injectable Filling Machine?

Compact GMP model with vacuum-driven powder wheel and servo motors
Built-in rubber stoppering system and turn tables with separate drives
Tool-less adjustment of doctor blade and wiper blade
Safety clutch system for vial breakage protection
“No Vial – No Fill” system, multiple dosing capability, and easy-removable SS316L contact parts
Options: PLC with HMI, Inbuilt Laminar Air Flow (Class 100), IQ/OQ documentation, and sampling/rejection system

These features ensure high precision, sterility, and efficiency.

Is the machine suitable for sterile production and what maintenance is required?

Yes, it is fully cGMP-compliant and ideal for sterile pharmaceutical environments. All contact parts are easily removable for autoclaving/sterilization and it supports cleanroom Class 100 operation with optional Laminar Air Flow. Maintenance is straightforward with tool-less adjustments. Regular procedures include cleaning the powder wheel, hopper, agitators, and stoppering components while maintaining controlled temperature and humidity for optimal powder flow.

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