cGMP Vial Filling Machine

Description

Injectable glass vials can be filled with automatic vial fillers, such as cGMP Vial Filling Machine. In accordance with cGMP regulations, our cutting-edge automatic vial filling apparatus is designed to be utilised in sterile spaces or clean rooms. The pharmaceutical sector has a wide range of application areas, including vaccines, biologics, cell and gene therapies, and single-dose or multi-dose medicines. One of Adinath International’s unique technological advantages is the modular design of these aseptic solutions, which enables each vial filling machine to be customised to meet the needs of each client while providing extremely affordable prices and delivery timeframes.

The turntable, stainless steel Stat conveyor belt, special eccentric pre-gassing, filling, and post-gassing make up the basic equipment. Easy-to-reach compact panels, non-toxic synthetic rubber tubing, and extremely effective and precisely constructed stainless steel 316L syringes. The risk of contamination is decreased by the close proximity of filling and stoppering equipment. The devices are made to be used under laminar flow protection and in a sterile environment. Dead ends and hard-to-clean areas have been removed from the un-scrambler itself. It is a completely automated system that combines online rubber stoppering, volumetric filling, and powder dosing on one platform. This design ensures optimal contamination control while minimising human intervention, shortening the laminar airflow, and saving important space in the sterile production area.

Salient Features of cGMP Vial Filling Machine

Suitable for the filling Volume of 2ml to 250ml.
Piston pump/Peristaltic pump aseptic filling.
Filling accuracy of ±0.5% to ±1%.
No cross contamination.
Easy to validate filling system for small/large batch production.
All Contact Parts Made from Stainless Steel 316L & framework by Stainless Steel 304.
Variable A.C. frequency drive for speed adjustment.

Digital Vial Counter for counting production output.
In-feed Turn Table/ Unscrambler for automatic feeding of objects.
On-line Mechanism.
“No Vial – No Filling” System.
“No Vial – Machine Stop” System.
IQ/OQ documentation can be provided.
PLC system with Graphical User Interface. (Optional)

Working Principle of cGMP Vial Filling Machine

The incoming dry vials (sterilized and siliconized) are fed through the unscrambler and suitably guided on the moving Delrin slat conveyor belt at the required speed of the correct placement below filling unit.

The filling unit consists of Filling Head, Syringes & Nozzles; Syringes & Nozzles are made of AISI SS 316L materials. A Star Wheel is provided which holds the vial during filling operation. A sensor is provided for ”No Vial-No Filling” operation. Syringes are mounted on eccentric block and driving through bottom main gear box. Volume can be increase & decrease by increasing or decreasing stroke length of piston as per filling size. Syringes is having non return valve for sucking and delivering situation to avoid volume variation. Liquid reaches to filling nozzles through silicon transparent pipe. Nozzles having up & down movement with help of cam mechanism, and it come down when vial hold by starwheel for filling operation and starts filling when it starts to move up and after completion of filling operation, starwheel delivers two vials together on conveyor for rubber stoppering operation.

Stoppering unit consist of Star wheel, Vibrator unit and Bowl. The sterilized and siliconized rubber stoppers stored in the vibrator bowl moves vertically to the rubber stopper chute. The vial is hold firmly by starwheel, which will be in continuous rotary motion and vial which is coming from filling unit get in to starwheel and move in rotary direction along with starwheel, during movement it picks up the rubber stopper from the exit end of the chute and rubber stopper pressed by fix single pressing roller, which is spring loaded. Then vial further move on conveyor and collected on out feed starwheel for next sealing operation.

Technical Specification of cGMP Vial Filling Machine

Model	ALVF-40	ALVF-80	ALVF-120	ALVF – 250
Filling Heads	Two	Four	Eight	Twelve
Production Rate	Up to 40 Vials/Minute	Up to 80 Vials/Minute	Up to 150 Vials/Minute	Up to 250 Vials/Minute
Input Specification
Vial Diameter	15mm to 70mm	15mm to 70mm	15mm to 70mm	15mm to 70mm
Vial Height	25mm to 140mm	25mm to 140mm	25mm to 140mm	25mm to 140mm

Filling Precision	±1%	±1%	±1%	±1%
Power Required	1 H.P.	1.5 H.P.	2 H.P.	2 H.P.
Electrical Characteristics	440 Volts, 3 Phase, 50 Hertz	440 Volts, 3 Phase, 50 Hertz	440 Volts, 3 Phase, 50 Hertz	440 Volts, 3 Phase, 50 Hertz
Overall Dimension	2050mm (L) x 850mm (W) x 1700mm (H)	2200mm (L) x 850mm (W) x 1700mm (H)	3000mm (L) x 945mm (W) x 1700mm (H)	3500mm (L) x 945mm (W) x 1700mm (H)

* 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 Automatic Vial Filler

Advantages of cGMP Vial Filling Machine

Full Regulatory Compliance & Easier Market Approval

Superior Sterility Assurance & Reduced Contamination Risk

High Filling Accuracy & Consistent Product Quality

Increased Efficiency, Productivity & Cost Savings

Ease of Operation, Cleaning & Maintenance

Enhanced Safety & Operator Protection

Key Features and Functionality of cGMP Vial Filling Machine

cGMP vial fillers are typically integrated into cleanroom environments and often housed in isolators or Restricted Access Barrier Systems (RABS) for enhanced sterility. Here’s a breakdown of their core aspects:

Filling Process: Automatically dispenses precise volumes of pharmaceutical liquids or powders into glass or plastic vials without human contact, using peristaltic pumps, time-pressure, or robotic systems for accuracy and consistency. Vials are then sealed with rubber stoppers, aluminum caps, or crimps.

Sterility Assurance: Operates in controlled environments with vaporized hydrogen peroxide (VHP) or PHP decontamination between batches. Features like “first air” exposure minimization and container closure integrity testing prevent microbial ingress.

Flexibility: Supports multiple vial sizes (e.g., 2–50 mL), formats (bulk or ready-to-use trays), and products (e.g., oncology drugs, vaccines). Quick changeovers (tool-free) and modular designs allow for versatile applications.

Compliance & Safety: Built with stainless steel frames, integrated environmental monitoring, and validation via media fills. Meets EU GMP Annex 1, FDA 21 CFR Part 211, and ISO standards for traceability and error prevention.

Automation & Integration: Often includes washing/depyrogenation tunnels, lyophilizers, labeling, and inspection stations. Robotic isolators enable small-batch filling with disposable components to reduce cross-contamination.

FAQ for cGMP Vial Filling Machine

What is a cGMP Vial Filling Machine?

A cGMP Vial Filling Machine is a fully automatic, modular vial filler designed for aseptic filling of injectable liquids or sterile powders into glass vials in sterile cleanroom environments. It combines volumetric filling (using piston or peristaltic pumps) with online rubber stoppering on a single compact platform. Built in strict accordance with Current Good Manufacturing Practice (cGMP) guidelines, it minimizes human intervention, reduces contamination risk, and ensures high sterility assurance for vaccines, biologics, antibiotics, and other parenteral products.

What is the production capacity and filling accuracy of the cGMP Vial Filling Machine?

The machine is available in multiple models with the following output:

ALVF-40: Up to 40 vials/min
ALVF-80: Up to 80 vials/min
ALVF-120: Up to 150 vials/min
ALVF-250: Up to 250 vials/min

It handles vial sizes from 2 ml to 250 ml (diameter 15–70 mm, height 25–140 mm) with a fill range of 2 ml to 250 ml. Filling accuracy is excellent at ±0.5% to ±1%, depending on product characteristics. Features like the “No Vial – No Filling” system and “No Vial – Machine Stop” system ensure precision and minimize product wastage.

Does the cGMP Vial Filling Machine support both liquid and powder filling?

Yes. This versatile cGMP Vial Filling Machine is suitable for both aseptic liquid filling (using piston/peristaltic pumps) and sterile powder dosing. It is widely used for vaccines, biologics, cell & gene therapies, oncology drugs, and antibiotic powders. The modular design allows easy customization for different products while maintaining full cGMP compliance and no cross-contamination.

How does the machine ensure cGMP compliance and sterility?

The machine is designed as a compact cGMP model with all product contact parts made from SS 316L (FDA-approved) and framework in SS 304. It features minimal dead legs, easy-to-clean surfaces, and supports integration with Class 100 / ISO 5 laminar airflow. Additional compliance features include:

IQ/OQ documentation
Optional PLC with 21 CFR Part 11 compliant GUI
“No Vial – No Filling” and “No Vial – Machine Stop” systems
Reduced human intervention and close proximity of filling & stoppering to lower contamination risk

It meets FDA, EU-GMP Annex 1, and WHO standards for aseptic processing.

What are the key features and optional accessories of the cGMP Vial Filling Machine?

Key Features:

Variable AC frequency drive for speed control
Digital vial counter
In-feed turntable / unscrambler for automatic vial feeding
Online rubber stoppering mechanism
No cross-contamination design
Easy validation for small to large batch production
Overload protection and safety systems

Optional Accessories:

PLC system with Graphical User Interface (HMI)
Inbuilt laminar airflow unit
CIP/SIP capability
Customized change parts for different vial sizes

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