Reliability, sterility, and efficacy are essential for the pharmaceutical industry; therefore, knowing your way around filling vials is important. Vial filling machines are essential to the manufacturing process for injectable drug products, vaccines, and biologicals. Understanding how a vial filling machine works and how it can be used in the manufacturing process is essential to complying with regulations and having a successful operation as a manufacturer.

This article will serve as a comprehensive overview of vial filling machines, including their definition, operations, applications, benefits, and considerations for use in your production facility.

What Is a Vial Filling Machine?

A vial filling machine is a piece of pharmaceutical equipment engineered specifically for filling sterile liquid or lyophilized (freeze-dried) drugs into glass or plastic vials accurately. As part of an aseptic production line, the vial filling machine, along with a capping machine, will fill, stop, and seal every vial to prevent contamination of the product by the operator or use of non-sterile containers.

A vial-filling machine will reduce the chance of human error when filling vials and act to automate the process of filling vials, which would otherwise be manually completed. Many vial filling machines include volumetric (bulking) and servo-controlled piston-based fill stations and other sterile filling systems; handling the sterile fill in a sterile environment and ultimately with speed, for large-scale pharmaceutical production.

Why Vials Are Essential in Pharmaceuticals

Before taking a closer look at the machine, it is necessary to understand why vials are still the most common container for many pharmaceutical products:

1.Flexibility: vials can be used for liquids or lyophilized drugs.
2.Chemical Resistant: vials made from glass (Type I borosilicate glass) are resistant to reactive ingredients.
3.Sterility: vials can be terminally sterilized or aseptically filled.
4.Agreed use: for the delivery of vaccines, antibiotics, hormones and injectables.

Given the critical role vials play, manufacturers need equipment that guarantees both quality and compliance.

Types of Vial Filling Machines

Vial filling machines vary in type, with each type selected for certain applications and production volumes. In general, vial filling machines can fall into 3 categories:

1. Manual Vial Filling Machines

These are very low-speed machines that only operate when the operator puts vials into the machine, and can put the required vials into the filling point and stopper point of the filling machine. As such, they do not lend themselves to large production and are typically seen in small labs, small-scale manufacturers, and R&D labs.

2. Semi-Automatic Vial Filling Machines

These machines can be combined to speed up production with operator input. The semi-automatic vial filling machine will be used in a scale that is cost-effective, where production speed is not the primary concern, and flexibility is more important.

3. Fully Automatic Vial Filling Machines

These types of vial filling machines are designed specifically for pharmaceutical production at a high level of production. They offer a seamless operation where all functions of filling are. stoppering, sealing, and in some cases labelling, all occur in the same line. Fully automatic filling machines require limited hands-on contact and give the satisfaction of providing full cGMP, EU GMP, and FDA compliance.

For example, IVEN Pharmatech sells fully automatic vial liquid filling machines that are operated and controlled to the highest international regulatory standards. Many manufacturers trust IVEN Pharmatech to assist with their filling and inspection machines all around the world.

Working Principle of a Vial Filling Machine

Although machines differ in their design details, the basic working steps are:

1.Vial Feeding: The filling machine is fed with pre-cleaned and sterilized vials. The vials will be fed into the filling machine using a conveyor.
2.Filling: A dosing system such as a peristaltic pump, piston pump, or time-pressure filling process to produce the correct amount of drug solution into the vials.
3.Stoppering: Rubber stoppers are added immediately after the filling process to maintain the integrity of the fill material.
4.Sealing: Aluminum caps are crimped onto vials to seal them from the outside and hold the stopper in place.
5.Inspection (optional): More advanced lines will include an inspection system to assess whether the fill volume is correct, as well as the particulate count and seal quality of vials.

Throughout this process, the vials will be processed in a controlled aseptic environment, usually under a laminar air flow system to allow for a clean grade of products.

Applications of Vial Filling Machines

Vial filling machines are critical in the pharmaceutical industry. Some of the common applications include:

1.Vaccines: Precise filling is important for both traditional vaccines and new mRNA vaccines.
2.Antibiotics and hormones: Both liquid and lyophilized drugs are vial packaged.
3.Biopharmaceuticals: Sensitive biologics require a fill process that can also be free of contamination.
4.Oncology drugs: High-value drugs require precise dosing.
5.(R&D) and clinical trials: The production will typically utilize small production runs for studies.

Benefits of Vial Filling Machines

If pharmaceutical manufacturers invest in a good-quality vial filling machine, they can take advantage of a variety of benefits:

● Accuracy and consistency: Automated doses will remove variability and allow for a more consistent procedure, and eliminate filling waste.
● Assurance of compliance: Automated machines are designed to meet compliance with GMP regulations, WHO regulations, and FDA regulations.
● A sterile process: The use of automated machines will decrease human contact with drug production and help ensure that human operators do not contaminate production.
● High-output production: Fully automatic systems can produce thousands of vials of sterile, injectable product each hour.
● Cost savings: The use of automated vial filling machines will reduce labour costs and product loss due to operator filling errors.

For example, the IVEN Pharmatech vial filling machines utilize some of the latest technologies in filling equipment combined with an inspection and testing system, together, all of which ensure full production capacity without compromising on quality.

How to Choose the Right Vial Filling Machine

The best possible choice of equipment will depend on your production requirements and company goals. When considering a vial filling machine, these will be the main aspects you should consider:

1. Production Size

Generally, a fully automatic filling system will be necessary if you produce sterile injectables on a large scale with commercial manufacturing output. A partially automatic or semi-automatic system would suffice for smaller-scale operations and most R&D labs, at least until commercial medicine production begins.

2. Type Of Product

Completing fill operations with machines will include a wide variety of applications, from sterile solutions, viscous solutions, or very sensitive biologics. Likewise, semi-lyophilized products will also require special dosing systems.

3. Compliance Requirements

Like all other pharmaceutical processing equipment, the vial filling machine will need to be compliant with the international regulatory bodies for Good Manufacturing Practice (GMP) regulations, as well as provide validation support with Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ).

4. Integration with Existing Lines

Determine that the machine can easily connect to existing upstream (washing, sterilization) and downstream (inspection, packaging) lines.

5. Supplier Experience

Aligning with an experienced supplier such as IVEN Pharmatech not only ensures high-caliber machines, but full project support from facility design to commissioning and operator training.

IVEN Pharmatech: Your Trusted Vial Filling Machine Solution

Are you looking for a dependable partner for installing or upgrading your pharmaceutical production line? IVEN Pharmatech is a world leader in high-quality equipment and turnkey projects and has tremendous experience in this area, drawing on almost 20 years in the business.

Many suppliers will simply sell you machines; however, IVEN Pharmatech is able to offer complete turnkey solutions. Every aspect of the project, including project planning, cleanroom/facility design, supplying the equipment, installing the equipment, validating the equipment, and providing service over the useful life of the equipment, is undertaken by IVEN Pharmatech personnel.

The IVEN Pharmatech team and highly trained professionals work with pharmaceutical companies to save time and reduce risk, while ensuring that the manufacturer meets all of the applicable international regulations.

With projects in over 50 countries, you can be assured of IVEN Pharmatech's extensive experience in experience with vial filling machines, IV solution lines, ampoule filling machines, syringe systems, and other pharmaceutical equipment related to pharmaceutical production. Each solution is built in compliance with GMP, FDA, and EU regulatory standards, so there is no doubt that the clients are confident in the quality and safety of their products.

If you are looking for a partner that you can trust to develop and successfully complete the project from concept to completion, IVEN Pharmatech is the best partner you can choose.

Conclusion

A vial filling machine is not just a machine; it is the centerpiece for sterile injectable drug production. By providing precision, sterility, and compliance, the vial filling machine has provided pharmaceutical manufacturers with the capability to deliver safe and effective medicines.

It doesn't matter if you're a new startup getting into production mode or an established manufacturer adding capacity; when the time comes to select a vial filling machine for your production, that choice can impact your production efficacy, compliance, and ultimately the scope of market opportunity.

If you're a company looking for a dependable partner, IVEN Pharmatech has demonstrated a strong history of quality supply in advanced vial filling machines and the availability of turnkey systems that reduce time to market while maintaining good quality.