Parenterals Powder Filling Machine

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

APF 12S (Single Head) : Up to 100 vials/minute APF 12D (Double Head) : Up to 200 vials/minute Fill volume ranges from 50 mg to 10 grams per dose (customizable). Filling accuracy is typically ±2–3% , depending on the consistency and uniform bulk density of the injectable powder.

Q: What are the key features of the Parenterals Powder Filling Machine?

Compact cGMP model with SS316L contact parts (easily removable for autoclaving/sterilization). “No Vial, No Fill” system to eliminate wastage. Built-in rubber stoppering unit, safety clutch to prevent vial breakage, variable AC frequency drive, and multiple dosing system. Options include PLC with HMI, inbuilt Laminar Air Flow, IQ/OQ documentation, and individual drives for filling & sealing.

Description

Parenterals Powder Filling Machine is specialized pharmaceutical equipment designed for the aseptic filling of sterile dry powders into vials, ampoules, or other containers used for injectable drugs. Parenterals refer to sterile dosage forms administered directly into the body, bypassing the digestive system. These machines ensure precise dosing, minimize dust generation from fine powders, and maintain sterility to prevent contamination, often operating in cleanroom class B environments with features like isolators and hydrogen peroxide decontamination. Parenterals Powder Filling Machine are critical in the production of dry powder injections, where the powder is filled into containers and later reconstituted with a solvent before use. They handle challenges like irregular powder flow, high-potency active ingredients, and the need for 100% in-process control (IPC) to avoid product loss.

Preparation: Sterilized powder is loaded into a hopper with agitators to maintain uniform density.

Filling: Powder is metered into pre-sterilized containers on a rotating wheel.

Control and Adjustment: Speed adjusts during filling/weighing; IPC checks dosage in real-time.

Closing: Automatic stoppering and sealing follow immediately.

Inspection: Non-destructive checks for fill weight, defects, and sterility.

The process adheres to cGMP standards, with terminal sterilization or aseptic processing.

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

Salient Features of Parenterals Powder Filling Machine

Compact GMP Model.
“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.
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.
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.
Multiple Dosing System.

Working Principle of Parenterals 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 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 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

Benefits of Parenterals Powder Filling Machine

Superior Sterility and Product Safety

Versatility and Flexibility

Hygienic Design, Low Waste, and Easy Maintenance

Cost-Effectiveness: Reduces labor, waste, and downtime while improving overall production quality and output.

Key Features of Parenterals Powder Filling Machine

Precision Dosing: Uses gravimetric, volumetric, or vacuum-assisted methods for accuracy, especially for ultra-low doses (sub-1 mg).

Sterility Assurance: Integrated laminar airflow, barrier systems, and automated sanitization.

Containment: Protects operators from toxic/potent powders and prevents cross-contamination via isolators and filtration.

Filling and Closing: Often monobloc for filling, stoppering/bunging, and capping in one workflow.

Output Rates: Vary from 60–200 vials per minute (VPM) for smaller models to 450 VPM for high-speed lines.

Additional Capabilities: In-line weighing, inspection, rejection systems, and compatibility with vials.

FAQ for Parenterals Powder Filling Machine

What is a Parenterals Powder Filling Machine and how does it work?

A Parenterals Powder Filling Machine (also known as Injectable Powder Filling Machine) is specialized aseptic equipment designed for filling sterile dry powders into vials for injectable drugs. It uses a vacuum-assisted powder wheel with pistons: sterilized powder is agitated in the hopper for uniform density, precisely metered into wheel ports via vacuum, excess is removed by a doctor blade, and then flushed into pre-sterilized vials using compressed or nitrogen gas. Filled vials proceed immediately to rubber stoppering to maintain sterility.

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

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

Fill volume ranges from 50 mg to 10 grams per dose (customizable). Filling accuracy is typically ±2–3%, depending on the consistency and uniform bulk density of the injectable powder.

What types of products and containers can it handle?

It is ideal for sterile injectable powders such as antibiotics and other dry powder injectables in the Pharmaceutical and Biotech industries. The machine handles vial sizes from 5 ml to 250 ml and is designed for high-sterility applications in controlled cleanroom environments (often with Class 100 laminar airflow).

What are the key features of the Parenterals Powder Filling Machine?

Compact cGMP model with SS316L contact parts (easily removable for autoclaving/sterilization).
“No Vial, No Fill” system to eliminate wastage.
Built-in rubber stoppering unit, safety clutch to prevent vial breakage, variable AC frequency drive, and multiple dosing system.
Options include PLC with HMI, inbuilt Laminar Air Flow, IQ/OQ documentation, and individual drives for filling & sealing.

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

Superior sterility assurance and product safety for injectable powders.
High precision dosing with minimal wastage and consistent results.
Hygienic, easy-to-clean design with fast changeover and low maintenance.
High-speed automated operation suitable for large-scale production and full regulatory compliance (cGMP).
Space-saving monobloc design with integrated stoppering.

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