Ampoule Filling and Sealing Machine – The Ultimate Guide

If you’re packing liquid drugs, then most definitely, you need an ampoule filling machine.

It provides an effective way of filling and sealing ampoules.

More importantly, going for an automatic ampoule filling and sealing machine will increase productivity, efficiency, and accuracy.

But, how can you choose the most reliable, and the high-quality machine that meets all safety standards?

Well, let’s find out.

What is Pharmaceutical Ampoule Filling and Sealing Machine?

A pharmaceutical ampoule is a modern automatic machine which has been designed specifically to increase the rate of production in the pharmaceutical industry.

This ampoule filling and sealing machine is specifically for the filling drugs into the glass ampoules.

Ampoule filling and sealing machine

As you will see later in this guide, these machines are designed to fill liquids in small glass bottles called ampoules.

Ampoule

The drugs while in their containers have to be protected from various environmental contaminants such as dust and various microorganisms.

The forms in which the drugs are contained in a glass ampoule are:

1. Liquid form
2. Solid form

• Powder form

Below is an example of ampoule filling and sealing machine.

Section of ampoule filling machine

What is an Ampoule?

An ampoule is a small glass bottle which normally contains a liquid drug which is mainly used for injection in hospitals.

This essentially due to the fact that glass materials do not normally react with its contents.

It ensures content within the bottle is of high purity.

They are hermetically sealed by melting the thin top with an open flame and usually opened by snapping off the neck.

Examples of the ampoules are shown in the pictures given below;

Sections of an ampoule

Open and sealed ampoules

Advantages of an Ampoules Filling and Sealing Machine

Some of the main advantages of ampoule filling machine include:

1. Ampoules protect the drugs from environmental dust and microorganisms.
2. Makes it easy to handle and store the drugs at the right content and amount to be used in hospitals.

• Full accessibility of the machine allows for easy maintenance of the machine

1. It has a faster changeover of ampoules since the process of production is very fast
2. It has a higher output of up to about 15000 ampoules per hour
3. It has flow meters which ensures that the flames are regulated easily

Disadvantages of Ampoules

Even though ampoules play a significant role in the pharmaceutical industry, it has the following disadvantages:

1. May cause injury if not properly opened – you may cut your fingers.
2. Some glass ampoules may fall into the drug content during the breakage hence ending up contaminating it.

Benefits of Ampoule Filling and Sealing Machine

Now, let’s have a look at the benefits of the ampoule filling and sealing machine.

Why should you have an ampoule filling machine?

Ampoule line

1. Easy integration with modern manufacturing technologies

Current Good Manufacturing Practice (cGMP), FDA, CE and ISO standards require pharmaceutical machines to meet set hygienic and safety standards.

Besides, it features up to date technology in the pharmaceutical industry.

Furthermore, adopting these machines makes it upgrade and integrate with existing systems.

2. Increases production capacity

This machine guarantees high production capacity to meet the increasing needs of ampoules.

You can produce hundreds of ampoules within a very short period of time.

For instance, automatic eight head ampoule filling & sealing machine provides output up to 12000 ampoules per hour.

3. Ability to monitor how the ampoules are being produced

Ampoule filling and sealing machine is an automatic machine.

A number of ampoule filling and sealing machines feature PLC systems.

They are fully integrated with easy to use HMI, allowing users to:

• Monitor ampoule filling process
• Change parameters
• Monitor errors in real-time, etc.

4. Ensures accuracy of contents

Whether the drug is in solid, liquid or powder form, the ampoule filling and sealing machine once set is able to fill the ampoules with the exact amount of the drugs within the bottles.

This will ensure there is no over or underdose of the drugs.

Remember, in the pharmaceutical industry, accuracy is very important.

Also, there will be no instances of wastages.

5. Easy to operate

With fully automates and easy to use HMI, operating ampoule filling and sealing machine is simple and straightforward.

Simple load the ampoules, products you want to fill, set parameters and monitor as the operation runs seamlessly.

In case of an error, the machine will automatically detect.

6. Ample cooling system

No need to worry about the overheating of the machine.

It features an efficient cooling system to avoid possible overheating that would reduce the lifespan of the machine.

Of course, other benefits such as the capacity will depend on the brand and specific application of the ampoule filling and sealing machine.

Types of Ampoules Filling and Sealing Machine

The machine comes in various types depending on the number of filling heads.

They are quite a number, and you can choose the ampoules filling machine depending on your specific needs.

Ideally, the basic features, operation, and technical specification are the same.

First, we will look at the available options in the market, then go ahead and focus on the various features.

Some of the most common types of ampoules filling and sealing machines are:

• 8 head ampoule filling and sealing machine
• 4 head ampoule filling and sealing machine.
• 2 head ampoule filling and sealing machine.
• 6-16 head ampoule filling and sealing machine

Section of ampoule filling machine

Features of two head ampoule filling and sealing machine

The two head ampoule filling and sealing machine has unique features that make it stand.

Here are the features;

1. Monoblock equipment that is designed with filler and sealer on a single platform
2. Filling contacts are stainless steel 316L materials.

• One motor which synchronizes with all the drives of the unit

1. Has a provision for nitrogen injection prior and after the liquid filling
2. The capability of filling a single dose at a range of 0.5ml to 25ml
3. Can fill either type B or type C open mouth ampoules.

• Has provision for the collection of ampoules in an upright position in the dead tray
• Has where the waste tips of ampoules are collected

1. Power voltage is 230 Volts, Single Phase, 50 Hertz, 4 Wire System
2. Overall dimension is 915mm (L) x 760mm (W) x 965mm (H) approx.

The most standing out benefit of these two head ampoule filling and sealing machine is the availability of minimum changeover of the ampoules.

The two head ampoule filling and sealing machine can as well fill at the rate of 10 to 250 ampoules per minute.

Features of four head ampoule filling and sealing machine

Here are features of the four head ampoule filling and sealing machine;

1. Has production output of around 90 to 100 ampoules per minute
2. The contact parts are made from AISI 316.

• Has got ampoule neck centering and the filling functions.

1. Can fill 1ml to 10ml ampoules
2. Has the capability of nitrogen flushing prior to and after filling.
3. Has got the capability of filling a single dose at a range of 0.5ml to 25ml.

• Can fill either type B or type C open mouth ampoules.
• The overall dimension of 1200 mm L * 1070 mm W * 965mm H

Features of six head ampoule filling and sealing machine

1. Its contact parts are made of stainless steel AISI 316L.
2. Drives have got a single motor unit.

• Has the prior and after nitrogen flushing

1. Provision for collection of ampoule tips
2. Easy regulation of the oxygen as well as LPG and the nitrogen flow
3. No ampoule no filling feature to avoid wastage.

• Has provision for attachment of PLC system
• Production is around 90 to 150 ampoules per minute.

1. Overall dimension is 2380mm (L) X 1200mm (W) X 1000mm (H)
2. Power requirement is 1 H.P., 380 Volts, 3 Phase, 50 Hz (4 Wire Systems)

Features of sixteen head ampoule filling and sealing machine

1. Its contact parts are made of stainless steel AISI 316L.
2. Provision for collection of ampoule tips

• Ampoule capacity of 16,000 to 36,000 ampoules per hour

1. Works with ampoule size of 1ml to 10 ml ampoules
2. Works under the principle of no ampoule no filling function.
3. Provision for PLC system.

• The power supply of 380 Volts and 50Hz

Well, as I had mentioned above, the working principle is the same.

The only difference is the number of filling heads each machine has.

So, I will look in details the 8 head ampoules filling and sealing machine since it is user-friendly, reliable as well as safe and this is all that you need for good operation.

Below is a picture of two head ampoule filling and sealing machine.

Ampule filling head

Parts of an Ampoule Filling and Sealing Machine

Ampoule filling machine is an assembly of many parts and components.

Some of the main sections include:

Ampoule filling line

· Filling source

This is where the liquid is fed. It acts as the reservoir tank for the whole filling process and can be refilled when the liquid is depleted

· Conveyor belt

This conveys the ampoule bottles from the filling station to the receiving station.

· Rotary pumps

To ensure that the right pressure is within the ampoule bottle.

· Stainless steel belt

This is the part where loading of the ampoules takes place and receives the sealed ampoules.

· Volume adjustable wheel

It is used to adjust the volume of the liquid that is fed into the ampoule bottles.

· Sensor of volume

Responds to the changes in the volume as adjusted by the adjustable volume wheel.

· Pedal switch

Adjustable for auto mode operation of the machine depending on the user preference.

· Plunger

Used to squeeze or push the liquid into the ampoule bottle.

· Needle bevel

To allow passage of the liquid into the ampoule bottle.

· Exhaust fume excavator

To channel out the fumes produced during the ampoule sealing process.

How Ampoule Filling and Sealing Machine Works

Well, you need to note that these ampoule filling and sealing machine works under the same principle.

The only difference is the number of filling heads.

Therefore, here I will look at the 8 head ampoule filling machine.

Below is a picture of 8 head ampoule filling and sealing machine.

8 head ampoule filling machine

Key features

1. It has self-centering grippers for the transportation of all the ampoule diameters within the size rage without the need to change.
2. Has Ampoule neck centering during the ampoule flushing and filling.

• Has the possibility of glass flushing before, during and after filling.

1. Also has AISI 316 L dosing syringes without the gaskets.
2. Has drip free adjustment for media having different viscosity
3. Has a connection to the sterilizing tunnel

• Works under the principle of no ampoule no filling function.
• Maintenance easy due to full accessibility.

1. Faster change over
2. Individual micrometric adjustment of the syringes.

Working of Ampoule Filling Machine

The infeed conveyor receives the ampoules from the sterilizing tunnel.

Later the ampoules are loaded into the conveyor belt into a screw conveyor in the upright position.

What happens again is that the screw conveyor then transports the ampoules to the segment wheel to be carried to a conveyor cradle.

It is worth noting that the conveyor cradle carries 8, 6 or 4 ampoules in a group through various stations.

Pre-gassing, before filling, filling, post-gassing after filling, pre-heating, heating which is done in vertical positions.

The machine performs the following operations

1. Ampoule transportation by the infeed conveyor, in-feed scroll, and the ampoule transfer into the transportation rack.
2. Normally 8 ampoules are advanced per machine stroke

• Centering the neck of the ampoule during the gas flushing and liquid filling.

1. Rotations of the ampoules in the pre-heating and heating stations
2. Removal of burned-off ampoule tips by the Clippers and ejection into a different container.
3. Discharge of the filled ampoules into a tray.

Liquid filling- The Core

1. The filling manifold is the first process.
2. Eight AISI 316 L dosing syringes and another eight stainless steel discharge needles

• A selection of electro-mechanical tube also knows as the rotary piston.

1. Micro-fine dosing adjustment volume for the filling of the ampoules
2. Also, an ampoule neck centering normally done during filling
3. And the principle of no ampoule – no filling without machine stopping.

The ampoule sealing

1. In the pre-heating with the adjustable flames and flow-meter for oxygen and combustible gasses.
2. The sealing station is also having oxygen and other combustible gases.

• Ampoule rotation during pre-heating and the sealing cycles

1. Clippers which then remove the ampoule tips into the waste bin
2. Safety valves and pressure reducers which is on the oxygen and the combustible gas circuit.
3. The to a stainless hood whose main function is to channel fumes out during the heating process

• Then the automatic ampoule discharge into the twin tray.

Production process

Technical Specifications of Ampoule Filling and Sealing Machine

Before you buy an ampoule filling machine, consider the following specifications:

Single head ampoule filling and sealing machine

· Production rate

Well, once the machine is in operation, it is able to produce about 120 to 250 ampoules per minute.

· Intended ampoule diameter

Remember that this varies with the type of ampoule filling and sealing machine.

For instance, 8 head ampoule filling and sealing machine works with ampoules with a diameter of 9mm to 17mm.

· Ampoule height

Eight head ampoule filling and sealing works with ampoule having a height of 50mm to 95mm.

· Filling range

This varies with the type of an ampoule filling and sealing machine.

For instance, eight head ampoule filling and sealing machine ranges within 1ml to 10ml.

· Nitrogen pressure required

This varies at about 1 kg/Cm² 

· Oxygen pressure

This ampoule filling and sealing machine works with the oxygen pressure of 1kg/Cm2.

· LPG pressure (Liquid Petroleum Gas)

Ampoule filling and sealing machine works at 0.5 kg/Cm2

· Optional accessories

Well, this ampoule filling and the sealing machine have a provision of Programmable Logic Control (PLC) system.

This has the advantage of helping you monitor the production process.

· Material

The ampoule filling and sealing machine has an aluminum profile cabinet which covers the whole machine.

· Overall Dimension

The ampoule filling and sealing machine come in various dimensions depending on the type you intend to use.

For instance, eight head ampoule filling and sealing machine has an overall dimension of 2780mm x 1200mm x 1785mm

· Power supply

This machine consumes power at around 380V 50Hz

How to Troubleshoot Ampoule Filling and Sealing Machine

What we need to agree with is that any machine has got some errors.

Perhaps, it may not be 100% efficient.

Therefore all that you need to do is to accept any challenges which may come to the course of production.

An ampoule filling and sealing machine like any other machine do have such errors, and they are not very common.

Ampoule filling process

The most prominent error and their solutions are outlined below;

· Failure of ampoule bottles to be sealed

Well, this may not be the wish of any user of this machine.

But in the course of production, some ampoules may not be completely sealed.

Solution: These can be solved by adjusting the sealing system in an appropriate angle to ensure efficiency in the sealing system.

· Delay in the delivery by conveyor belt

No worry again, sometimes the conveyor may fail to pass the bottles at the right time for filling.

This often affects the sealing system.

Solution: This is automatically solved by adjusting the system. But again remember that any ampoule filling and sealing machine works under the principle of “no ampoule no filling function.”

· Unleveled fills

Well, sometimes the fills may not level. This might be quite frustrating.

Then what do you do?

Solution: You need to ensure that the ampoule filling and sealing machine is on a flat floor meant for production.

· Delayed change-over

Again, during the changeover from one ampoule to another, some ampoules may not be in a filling line.

Solution: Ensure that there are correct spacers along the production line.

Finally, the operators should ensure that they do a visual inspection and monitoring the ampoules as they are filled and sealed.

· Head dive may fail to work

This may fail to work for some reason but often due to mechanical problems.

What may happen is that the airlines that have the connection to the head dive may have a leak or sometimes may become disconnected.

Solution: Ensure that you check all airlines as well as the air compressor to ensure all connections are secure and that compressed air is supplied to the machine.

The machine operators are often advised to check the touch screen PLC (Programmable Logic Control) to ensure correct settings of the machine.

For instance, the head dives when it is set to the dive, or down, a position for the changeover.

The machine will not perform as expected.

In these cases, the machine operator simply needs to touch a button to reach the correct setting and start again with production.

That is it.

Applications of Ampoule Filling and Sealing Machine

The machine has a wide range of applications in various sectors, and this makes the machine very flexible in nature.

The following are some of the areas where the ampoule filling and sealing machine finds its uses;

Ampoules

1. Pharmaceutical Industry

Ampoule filling machine plays an integral role in the pharmaceutical industry.

Of course, this is due to the fact that most drugs are stored in ampoule bottles.

Due to the high demand, there is need to adopt, fast, efficient and reliable automatic ampoule filling and sealing machine.

So as shown with various types of the ampoule filling and sealing machines highlighted earlier, the pharmaceutical industry has benefited from this innovation.

2. Food Industry

Well, various food industries dealing with liquids for instance beverages have adopted the use of automatic filling of the bottles with given food content.

Like the pharmaceutical industry, the food industry has also benefited from the ampoule filling and sealing machine.

For example, many supplements are packed in ampoules.

3. Cosmetics industry

Ampoule filling and sealing machine is a useful machine in the cosmetic industry too.

Different products in the cosmetic industry such as natural oil or lotions are packaged in ampoules, making a useful accessory in the industry.

4. Chemical industry

Most of the laboratory chemicals are filled in their containers using the ampoule filling and sealing technique.

The chemicals must be filled accurately and without contaminants.

This too makes ampoule filling and sealing machine an important machine in the industry.

Conclusion

As you can see, ampoule filling and sealing machine is an important equipment in the pharmaceutical, food processing, cosmetic and chemical industries.

However, to choose a high quality and reliable machine, you need to understand every aspect mentioned in this guide.

That way, you will get the best machine for your specific needs.

So I believe that having gone through this whole guide, you can get the ampoule filling and sealing machine.

For free consultations on ampoule filling line, contact us today.