Automatic Production Line for Aseptic Eye Drops

Aseptic Filling Machine: The Ultimate FAQ Guide

Before you invest in a new aseptic filling machine, read this guide.

It covers every information you’re looking for about aseptic filling equipment such as parts, working principle, and quality standards, amongst other things.

Keep reading to learn more.

What is Aseptic Filling Machine?

An aseptic filling machine is a piece of electromechanical equipment.

You will use an aseptic filling machine to fill various packaging containers.

It is especially suited as it maintains sterility of the entire filling process.

Aseptic filling machine

Why should you Invest in an Aseptic Filling Machine?

Aseptic filling equipment will benefit your business in a lot of ways.

• You will fill many bottles quickly and efficiently.
• You will produce sterile products as the machine prevents possible contamination.
• The fully automatic aseptic filling machine will do all aseptic filling by itself.
• Using an automatic aseptic filling machine means you will save a lot in the long run.
• An aseptic filling machine has a high production capacity meaning you will meet all your clients’ needs.
• You will make more sales and high profits.
• By using an aseptic filling machine, you will meet all the quality standards of aseptic filling.

How does Aseptic Filling Process Work?

In today’s industry, you will find a variety of aseptic filling machines.

The packaging container will determine the working principle of an aseptic filling machine.

What will remain constant in the entire process is the sterilization stage.

When you purchase an aseptic filling machine, make sure the manufacturer fully trains your team.

This training will enable your team to operate the machine appropriately once installed.

You will use weight or volume to fill the containers.

A volumetric filling will use a magnetic flow meter, which ensures the accuracy of the flow of liquid.

These flow meters will control the membrane valves to begin and end the filling cycle.

You will fill the bottles without touching the bottle since the product is in liquid form.

If you have products that foam, you will control the flow rate during the filing process to avoid spillage.

You will fill by weight if the packaging container used to hold the liquid is in grams.

This process can be difficult when using high-speed operations.

It is because collisions and vibrations with the system may alter the measurements.

In short, the aseptic filling process involves:

i. Feeding the containers

ii. Feeding the liquid or product

iii. Switching on the machine

iv. With the help of conveyor belt the machine moves the containers

v. It fills the containers

vi. Seals the containers

vii. Inspects for quality control

viii. Prints necessary information

ix. Discharges fully filled containers

Remember, most modern machines have fully automated system.

Which Packaging Container do Aseptic Filling Machines use?

An aseptic filling machine is capable of filling a variety of containers.

The packaging containers used depends on the kind of industry using the aseptic filling machine.

The various packaging containers that an aseptic filling machine can fill include:

 Aseptic filling containers

• Bottles
• Vials
• Special boxes
• Disposable syringe
• Eye drops
• Infusion bottles

Which Types of Aseptic Filling Pharmaceutical Machines are there?

There are various types of aseptic filling pharmaceutical machines in the market.

These types are specialized to do a specific purpose.

Some of the aseptic filling pharmaceutical machine available include:

1) Aseptic Vial Filling Machine

A vial is a small container that is cylindrical and is used to hold liquid medicines.

This machine can fill nested pre-sterilized ISO vials.

It also has a pump that will offer you 10x improvement in variety compared to conventional peristaltic pumps.

This machine works via a volumetric system that has dividing nozzles.

The machine also places rubber stoppers over the vials.

2) Aseptic Bottle Filling Machine

With this machine, you can fill a variety of bottles.

The machine has a device that will automatically detect bottles on the conveyor.

It also has a photocell that will make the machine stop if no bottle is detected.

The machine also comes with a turret automatic height adjustment.

This feature will enable you to adjust the height to accommodate bottles that are of various sizes.

3) Aseptic Ampoule Filling Machine

An ampoule is a small bottle that contains liquid drugs used in hospitals for injection.

This machine effectively fills drugs into ampoules made of glass.

The machine hermetically seals the bottle by melting the top with a flame and then snapping off the neck.

4) Aseptic Eye Drop Filling Machine

This machine fills eye drops in containers.

It is easy to operate as it applies a computer-controlled peristaltic pump filling.

You can use an aseptic eye drop filling machine to:

1. Automatically fill liquids
2. Automatically add caps
3. Automatically add inside stoppers.
4. Automatically screw caps

5) Aseptic Syringe Filling Machine

By using a pre-filled syringe will make it easier for doctors to administer drugs.

This machine is precise and accurate at filling and stoppering syringes.

The aseptic syringe filling machine can also have PFS installed into auto-injectors.

It offers you an accurate stopper placement together with bubble-free filling.

You will achieve this through a servo-driven mechanical placement.

This servo-driven mechanical placement has a vacuum control and inert gas backfill.

What are the Components of the Aseptic Filling Machine?

An aseptic filling machine has different parts that all work together to accomplish the aseptic filling process.

Here are some of the main parts of an aseptic filling machine:

Heating and Cooling System

This part helps you with the sterilization process.

You will apply enough heat in this system to eliminate all contaminants.

The sterilization required and the container used will determine the temperature of the heat applied.

Closing Station

This part does the work of sealing the aseptic containers.

It is important to note that separate containers have different closing mechanisms.

This part makes sure that no contamination occurs during this process.

Barrier Protection

This part has the main function of minimizing any contamination of the containers, the product, or the machine.

Transparent polycarbonate panels are the main barriers used in most aseptic filling machines.

Filling Station

Filling station

In this station, the aseptic filling machine will fill the containers that hold the fluids.

These containers can be ampoules, bottles, or vials.

You will do the filling in batches.

The high capacity aseptic filling machines will contain two separate filling stations all in a single device.

Programable Logic Controller [PLC] and HMI

An aseptic filling machine automatically does all functions with no human involvement.

It is to ensure the sterility of the products and the machine.

The Human-Machine Interface [HMI] is a touchscreen panel that enables you to control and monitor the filing process from a central station.

Technological advancements in the manufacture of aseptic filling machines ensure it is productive.

Cleaning System

An aseptic filling machine has specialized nozzles.

You will use these nozzles to sterilize the outer as well as the inner surface of the aseptic filling machine.

Some aseptic filling machine can apply various washing cycles to make the cleaning process reliable and effective.

Loading Station

This unit is the part where you will place the containers that you will fill.

It can be called in various names depending on the type of container used.

It can be called a bottle loading, ampoule loading, or vial loading station.

Conveyor Belts

This part of the aseptic filling machine will assist in transporting the containers from one point to the next.

Some machines have grippers installed that hold the containers in place during the filing process.

Aseptic Container Forming Station

An aseptic filling machine will use either a thermoforming or blow molding technique which forms the current aseptic container.

This station will mean that your aseptic filling machine will make and fill the containers at the same time.

Which Sterilization Technique do Aseptic Filling Machines use?

Applying different sterilization techniques will enable you to destroy all forms of microorganisms from a substance.

Some of the sterilization techniques that a Sterilization Technique use include:

Chemical Sterilization

Here you will sterilize by using gases.

The gas quickly penetrates the product meaning the sterilization is effective.

The gases that you will use for sterilization are will kill all germs and bacteria.

Ethylene dioxide and carbo-dioxide are the gases that you will apply in this process.

You will add carbon-dioxide to minimize the chances of an explosion.

Heat Methods

This method is a commonly used type of sterilization.

Using heat will kill the microbes contained in the substance.

In this technique, if you expose the substance for long to heat, the better it is sterilized.

If you use a high temperature means you will expose the substance to heat for a shorter time.

You can use two types of heat sterilization technique:

1. Dry heat method
2. Moist heat method

Filtration Methods

In this sterilization process, you will pass fluids through bacterial filters to remove the microbes in them.

You will use this method to sterilize heat-sensitive liquids.

This method has the disadvantage of clogging and that you have to apply it for a long.

You can use three types of filters in the filtration sterilization process.

1. Seitz filters
2. Membrane filters
3. Candle filters

What is the Latest Technology in the Aseptic Filling Machine Industry?

You should choose an aseptic filling machine with the latest technology as it is more reliable and effective.

Keep in mind that new technologies and advancements are always on the way.

Some of the latest technology in the aseptic filling machine include:

Sealing Technology

Better aseptic filling machines have the best sealing technology in place to avoid contamination.

The technology allows you to seal the container without direct contact with the product in the container.

Electron Beam Sterilization Technology

This technology will use beta radiation with high voltage rates in line with low penetration for sterilization.

An electron beam sterilization is efficient and reliable.

The production of ion energy in continuous beans or pulses will destroy all microbes.

An Auto Changeover

An auto changeover is an essential feature as it helps you achieve the perfect aseptic filling process.

You will use the machine in a way that will not affect the sterilization process.

Servo Motor

This motor plays a major role in terms of angular and linear position.

This part has a DC motor gear reduction unit, control unit, and position sensing unit.

Energy Saving

Reducing energy consumption has the benefit of increasing profit margins.

New aseptic filling machines are better at reducing energy consumption.

Safety Mechanism

With a safety mechanism installed, you will minimize risks and damages while operating the machine.

A safety mechanism in the aseptic filling machine includes:

1. A servo motor will ensure accurate and reliable filling.
2. Automatic overload protection that will stop the machine if it notices a possible overload.
3. An easy to use switch for the operator.

High-Performance Polyformaldehyde

This part will reduce the cost of maintaining the machine.

The reason is that it is heat resistant and self-lubricating.

Servo Ball Screw

This unit enables you to achieve accurate filling.

With a high precision splitter, you achieve accuracy and stability.

Human Machine Interface [HMI]

To acquire the best sterilization, you need to monitor all stages of the aseptic filling machine.

By minimizing human interaction, you improve the reliability, consistency, and accuracy of the aseptic filling machine.

This panel will enable you to monitor and control the aseptic filling machine from a central station.

How do Aseptic Filling Machine Manufacturers Conduct Factory Acceptance Tests (FAT)?

A factory acceptance test determines the functionality of the machine with its technical specifications.

A complete FAT test will involve:

Planning

This process makes you plan for the complete FAT test.

You will lay all the steps you will undertake during this process.

Risk Assessment

This step enables you to identify safety and technical risks.

You will test all critical parts in this step, and you should communicate with all technicians involved in the FAT test.

Clearly define areas to be tested and which parties will conduct the testing.

Test Procedures

The manufacturers will test the hardware and software extensively.

Extensive testing ensures that the machine works properly under extreme conditions.

Rectification

Once testing is complete, you will use all the information gathered to rectify the errors.

The manufacturer also uses this information for future manufacture of aseptic filling machines.

What Determines Aseptic Filling Machine Price?

Its capabilities determine the price of an aseptic filling machine.

High-end aseptic filling machines with lots of technology will cost more.

The filing capacity will determine the price of an aseptic filling machine.

Besides, the material used to manufacture an aseptic filling machine will determine the price.

High-quality stainless steel makes the machine costly.

Aseptic filling machines that have to conform to all quality standards are considered expensive.

The bigger the aseptic filling machine, the pricier it is considered.

What are the Quality Standards for Aseptic Filling Machine?

The best aseptic filling machines have to comply with some quality standards set by international bodies.

Quality standards ensure that the machine has met the required specifications and is safe for the filling process.

Since maintaining sterility is a high priority, these standards are mandatory in the manufacture of aseptic filling machine.

Buying an aseptic filling machine that does not conform to these standards will lead to wastage of money and time.

That said, here are the quality standards that an aseptic filling machine must adhere to:

Food and Drug [FDA] Quality Standard

FDA plays a major role that ensures the safety and compliance of an aseptic filling machine.

The FDA requires that an aseptic filling machine uses:

1. The best designs
2. and approved sterilization techniques such as electron beam and hydrogen peroxide

Current Good Manufacturing Practice [cGMP] Quality Standard

You are advised not to purchase an aseptic filling machine that does not conform to this standard.

This quality standard considers the material used, the design as well as the working principle of an aseptic filling machine.

Restriction of Hazardous Substances [RoHS] Quality Standard

This quality standard makes sure your aseptic filling machine will not have, produce, or emit certain hazardous materials.

RoHS ensures the safety of plants, animals, and the environment at large.

European Medical Agency [EMA] Quality Standard

This quality standard makes sure all products are the same concerning quality and safety.

They ensure that the manufacturers are using the current equipment to make an aseptic filling machine.

CE Quality Standard

CE is an important standard as you will not be able to import or sell an aseptic filling machine without this mark.

This standard has been embraced globally as an important quality standard.

CE quality standard majorly applies to European Economic Areas.

USP 116 Quality Standard

USP 116 ensures that the environment is suitable when you are filling aseptic.

With this means, the machine will deliver quality results.

The main focus of this quality standard is on Microbiological Control and Monitoring of Aseptic Processing Environments.

Which Pharmaceutical Equipment can you Integrate with Aseptic Filling Machine?

The pharmaceutical equipment you can integrate with an aseptic filling machine means you will fulfill your production needs seamlessly.

Some of the pharmaceutical equipment you can integrate with an aseptic filling machine include:

Blister Packaging Machine

You will use this machine to pack tablets, syringes, ampoules, and capsules.

Cartoning Machine or Cartoner

This machine will enable you to pack and ship your products to the market safely and securely.

It can fold cartons of various shapes and sizes.

How do you Maintain an Aseptic Filling Machine?

Maintaining an aseptic filling machine will enable it to work efficiently for a long time.

All broken and worn out parts should be replaced or repaired with genuine ones immediately.

Also, all moving parts have to lubricated to minimize tear and wear.

You should conduct a continuous inspection of the aseptic filling machine to ensure all parts are functioning properly.

Which Industries use Aseptic Filling Machine?

You will use an aseptic filling machine in various industries.

Some of the industries include:

• Dairy industries
• Beverage industries
• Medical industries
• Pharmaceutical industries
• Food industries
• Chemical industries

Aseptic filling machine

Are there Limitations of the Aseptic Filling Machine?

Even the best aseptic filling machines have some downsides.

Some of the limitations of an aseptic filling machine include:

Cost of the Machine

The machine is costly, meaning you have to spend a lot to purchase and install it.

Pump System

You will transport the product by using pumps in the aseptic filling machine.

With this in mind, the product has to be a homogeneous fluid for easy pumping.

On the contrary, If the liquid Is not homogeneous, it may block the pipes and pumps of the aseptic filling machines.

Range of Use

You can only use aseptic filling machines to fill a limited range of products.

With this limitation, you can only fill specified liquids, and you need to have other machines for other fluids.

Training of Personnel

The main benefit of using an aseptic filling machine is that it maintains the sterility of the product.

Many parts of the machine will achieve this.

You will need to have trained personnel to be able to operate the aseptic filling machines properly.

How does Aseptic Liquid Filling Machine compare to Aseptic Powder Filling Equipment?

You will fill aseptic liquids in containers using an aseptic filling machine.

On the other hand, an aseptic powder filling machine will fill powder in containers.

 Powder filling machine

How do you Troubleshoot Aseptic Filling Machine?

Troubleshooting an aseptic filling machine enables you to identify issues and solve them quickly.

The steps involved in troubleshooting involves:

Identifying the Issue

In this step, you will gather information, verify the issue, try quick fixes, or escalate the issue.

Actual Repair

In this step, you will have identified the problem.

You will then repair or replace the issues and verify by testing to make sure it is working properly.

How is Aseptic Filling Machine different from other Liquid Filling Machines?

To ensure you completely sterilize the aseptic filing process, you will use aseptic filling machines.

Aseptic filling machines are generally pricey compared to liquid filling machines.

Liquid filling machine

You will use aseptic filling machines in the pharmaceutical and food industries.

You can operate other liquid filling machines manually, whereas aseptic filling machines are fully automatic with less human involvement.

Depending on your specific needs, SaintyCo offers a range of aseptic filling machine.

Contact us today for custom and affordable aseptic filling machines.