Most likely, you are looking for “intelligent” and a modern aseptic filling machine for your disposable syringe, vials, eye drop, infusion bottles and many others.
Well, it is your lucky day since this guide breaks down every detail of the aseptic filling process.
From the basic definition, history, working principle, components, features and future technology – you’ll get all insights on everything about the aseptic filling machine.
It will help you choose a machine that minimizes downtime and product loss while maintaining hygienic and sterile levels to set standards.
Let’s get started:
- Aseptic Filling Basics
- Main Parts of Aseptic Filling Equipment
- Working Principle of Aseptic Filling Machine
- New Technology in Aseptic Filling Systems
- Quality Standards Aseptic Filling Process
- Integrating Aseptic Filling Machine with Other Support Equipment
- URS for Aseptic Filling Machine
- SaintyCo Aseptic Filling Line
Aseptic Filling Basics
An aseptic packaging process is a common technique in the pharmaceutical and food industries.
So far, it is a popular technique due to its reliability, efficiency and safety.
Basically, this process involves:
ii.Sterilizing packaging container, box or material
iii.Maintaining the sterility of both product and packaging container throughout the process
Obviously, this requires equipment you can easily control most of the operational parameters to meet the set quality, hygienic and safety standards.
To go about the aseptic packaging process successfully, you need an efficient aseptic filling machine.
And, throughout this guide, you will learn how to choose the best aseptic filling equipment.
Let’s start with the basics.
Aseptic Filling Machine Definition
An aseptic filling machine is an electromechanical equipment, specifically designed to fill packaging containers while maintaining the sterility throughout the entire process.
Maybe that may seem difficult to understand at the moment.
Don’t worry; this guide will breakdown this in details shortly.
Depending on the situation, the packaging container may be special boxes, vials, bottles or disposable syringes.
A good example of an aseptic filling machine is the automatic production line for aseptic eye drops.
Basically, the machine looks like this:
Aseptic filling machine
Of course, these machines come in a range of shapes and design.
So, you will find aseptic filling equipment with many parts, whereas, others will have just a few.
Therefore, for the scope of this guide, the main focus will be on the main components.
But, even before you explore more about this machine, let’s appreciate the history and progress in the aseptic filling equipment.
Aseptic Filling Equipment History
The desire to have an efficient aseptic filling process begun in 1927.
It is during this time that the first machine was developed.
Well, here is quick progress on the various development stages of aseptic filling equipment:
- Heat-cool-fill (HCF), was the first machine developed in 1927 by Olin Ball
- George Grindrod developed in Avoset Process in the 1940s
- Dole Aseptic Process was developed by McKinley Martin in the late 1940s
- In the 1940s, Roy Graves started sterilizing milk
- Tetra Pak introduced tetrahedron in 1962
- FDA approved the use of hydrogen peroxide for sterilization in 1981
As you can see, it has been a long journey in developing an efficient aseptic filling process.
Interestingly, all these developments aimed at realizing the most cost-effective, reliable and efficient aseptic filling process.
Today we have some of the most efficient aseptic filling machines, featuring the best technologies in the industry.
Erik displaying the first Tetra Pak – Photo courtesy: Wikimedia
With that in mind, it will be unfair to talk about the machine without discussing the packaging container.
Of course, the aseptic process is not complete without the packaging container.
Take a look:
Packaging Container for Aseptic Filling Process
First, the nature of the product will depend on what you want to fill in the container.
It could be a liquid food product, semi-liquid food product, medicine or vaccine.
Whichever the case, you should ensure the product does not react with the container.
It is the first step to prevent unnecessary contamination of the product after the sterilization process.
Now, let’s come back to the packaging container for the aseptic filling process.
Most of the aseptic filling equipment are designed to handle a range of containers.
In fact, the working principle of most machines remains almost the same.
However, the container handling mechanism may be adjusted to conform to the specific requirements.
Here are some of the most common aseptic filling containers:
Aseptic filling containers – Photo courtesy: EPM Magazine
Of course, others may be as large as these:
Large aseptic filling bottle
Depending on the task at hand, before you choose an aseptic filling container, you should consider the following:
i. Type of aseptic filling system – Which type of aseptic filling machine will you use?
Can it accommodate the type of bottle you intend to use?
Well, you will learn more about aseptic filling systems later in this guide, keep reading.
ii. Properties of both the container and product – Here, the main focus will be on physical and chemical properties.
iii. Possible interaction between the product and filling container
iv. Shipping and handling procedures
v. Compliance with the set safety standards and regulations
vi. End user or consumers who will use the product
Once you have all these in mind, you can go ahead to shop for an aseptic filling system.
Now, that you know the basics, let’s advance this discussion further.
From the earlier definition, an aseptic filling is an assembly of parts and components.
Now, let’s break down this machine to its specific parts.
Main Parts of Aseptic Filling Equipment
From the definition, an aseptic filling line is an assembly of various parts and components, working together to achieve basic functions – sterilize, fill, and seal.
Whether you’re looking for:
- Aseptic vial filling line
- Aseptic ampule filling line
- Aseptic eye drops filling line, or
- Any other aseptic liquid filling solutions
The aseptic filling line has hundreds of parts.
However, for the scope of this guide, the main focus will be on the main parts of aseptic filling equipment.
However, if you want to know all the parts and components, get the product manual.
You will get a detailed technical drawing, alongside the part name and number.
For the scope of this guide, let’s have a quick overview of the following parts:
i. Cleaning system
Cleaning is an important aspect of the aseptic filling.
Sterilizing vials – Photo courtesy: Pharmaceutical Machinery
Depending on the design of the aseptic filling machine, the machine features special nozzles.
The nozzles clean and sterilize both the inner and outer surface of the container.
In fact, there are machines with varying washing cycles for effective and reliable cleaning.
ii. Heating and cooling chambers
They form part of the sterilization process.
Here, the aseptic filling system supplies enough heat to kill and remove all contaminants.
The heating temperature will depend on the container and sterilization requirements.
iii. Filling station
It is where the machine fills containers, be it vials, ampoules, bottles, or boxes with the right materials.
Aseptic filling station
Aseptic filling machine is such that it fills containers in batches.
Alternatively, high capacity aseptic filling machines can have two different filling stations in a single machine.
iv. Closing station
It features different sealing mechanisms depending on the aseptic containers.
Remember, these containers have varying closing mechanisms.
Still, it should close the containers with virtually no instances of contamination.
Closing station for aseptic filling machine
v. Barrier protection
A barrier is part of the aseptic filling equipment design to minimize possible contamination of the machine, product or container.
Quite a number of aseptic filling systems feature transparent polycarbonate panel.
vi. Fully automatic system with touchscreen HMI
PLC system makes the machine more robust and reliable.
HMI touch screen panel
Aseptic filling system automatically controls all operations, with virtually no human intervention after setting the necessary parameters.
Implying, from the touchscreen HMI, you can monitor processes, change and enter parameters according to your unique process needs.
In fact, a number of machines feature advanced analytical technologies to enhance productivity.
vii. Conveyor belt systems
It helps in transporting containers to the filling station.
Other machines are fitted with grippers that hold the container during the aseptic filling process.
Bottles move along the conveyor system – Photo courtesy: Packaging Strategies
Basically, this forms part of the transport system.
viii. Loading station
It is where you will put all the containers you want to fill.
Depending on the container type, you may call it bottle loading, ampoule loading, vial loading, etc.
Section of the loading station
ix. Aseptic container forming station
Steps in blow molding 1 to 8: Photo courtesy: Wikimedia
Implying, your aseptic filling system will make containers and fill them at the same time.
As earlier stated, these are not the only parts of the aseptic filling system.
If you want to learn more about the type of aseptic filling machine you’re using, kindly request for a product manual.
For now, let’s see how an aseptic filling machine works.
Working Principle of Aseptic Filling Machine
Remember, there are many types of aseptic filling process today.
Implying, the working principle of aseptic filling machine will depend on the type of packaging container.
And even with all variations, there is one thing you must always remember, the entire process must remain – sterile.
And since we cannot explore a detailed working principle for all aseptic filling machines available in the market, will quickly look a brief summary for each equipment.
But, before you acquire any aseptic filling machine, after installation, let the manufacturer train your team on how to operate the equipment.
To help understand how the aseptic filling equipment works, here is a video of vial filling line.
Remember, vial filling process, is a practical example of the aseptic filling process.
You can watch this video before proceeding to the next section – it illustrates the entire process, from sterilization, filling, capping to quality inspection:
Whether you want to use plastic laminate, can, flexible pouches, vials, or ordinary bottles, you can choose an aseptic filling machine that integrates well with your process.
Type of Aseptic Filling Line
The most basic working principle of aseptic packaging machine may include the following:
- Positioning container in the right orientation, filling, then sealing.
- The entire process takes place in a sterilized environment.
- Of course, this is for preformed containers.
- Aseptic filling machine may form the container and sterilize.
- While maintaining the same environmental conditions, it will fill and seal the container.
Electronic sensors and lights for accurate filling
Obviously, the design of the two machines will be different.
Because one uses the ready-made filling container.
On the other hand, the aseptic filling machine must make filling containers it uses.
And this leads us to the question?
How does the aseptic filling system make its containers?
Most of the packages made during the aseptic filling process are plastic.
Therefore, the machines adopt either:
Using Preformed or Ready Made Containers
Here, you will only feed the container into to aseptic filling machine.
This is because the containers come as empty vessels, which only requires filling and sealing.
Still, you will have to sterilize the containers to the required safety standards.
- Blow molding – here, a hollow container is formed, sterilized, filled to the required level then sealed.
- Thermoforming – plastic container heated to the right temperature, then formed into a suitable shape.
- It is then sterilized, filled and sealed.
In short, the complexity of the machine will depend on the aseptic filling process.
With that knowledge, let’s sum us the aseptic filling machine working principle as follows:
a) Sterilizing Stage
Here, the machine should sterilize:
- Packaging container
The sterilization technique or method you will at this stage will depend on the nature of product, packaging container and aseptic filling machine.
Sterilized vials ready for filling
For instance, you can use any of the following:
Heat sterilization technique
Depending on the design of your machine, you can use “dry” heat or “moist” heat.
Moist heat can be in the form of pressurized saturated steam or hot water.
In most cases, the temperature may range from 121°C to 129°C.
On the other hand, “dry” heat is basically hot air or superheated steam.
Here, the temperature range may be 176°C to 232°C.
You should pay attention to the holding time and high temperature for an effective sterilization process.
Sterilization using Chemicals
Here, your aseptic packaging system will use hydrogen peroxide.
It is one of the most popular sterilization methods in the most aseptic filling machine.
Alternatively, you can use certain acids such as ethanol, ethylene oxide, etc.
Sterilization using radiations
Even the e-beam technology that is common in most aseptic filling machines is part of the radiation sterilization technique.
With gamma radiations, you can treat packages in bulk.
You will learn more about it shortly.
After sterilization, your machine will begin the filling process.
Let’s see what happens here:
b) Filling Stage
Filling the container is a critical stage.
Depending on the technique an aseptic filling machine uses, it should maintain both the product and container in their sterilized state.
That is, whether the material is flowing in the holding tubes, moving through various tubes, or holding tank, the state must not change.
The same applies to the filling container.
Again, aseptic machine should have deaerator to remove air during the aseptic filling process.
This will prevent possible oxidation reaction of the products after filling.
c) Sealing Stage
Aseptic packages are hermetically sealed thereby, preventing possible contamination after packaging.
It helps to maintain the integrity of the product.
Vial capping stage
d) Quality Inspection Stage
It is the last stage in aseptic filling and sealing process.
Here, you need to check whether the products have been sealed to the right level, sealed properly and batch number printed.
Quality inspection after filling and sealing vials
In a nutshell, there is nothing unique here.
The process is simple and straight forward.
More importantly, modern aseptic filling systems have a fully automatic system.
You will only press buttons, key in commands and everything will be set.
Interestingly, you will monitor all operations via the touchscreen HMI.
Again, for a successful aseptic filling process, you must choose a modern machine which features the best technology.
Through this, you will save cost, ensure the accuracy and consistency of the aseptic filling process.
Having said that, let’s look at the recent developments in the aseptic filling systems.
New Technology in Aseptic Filling Systems
As earlier mentioned aseptic filling process has come a long way.
Of course, you could see this from the working principle, parts, components and designs available in the market.
Implying, more innovations, and improvements are yet to come.
Therefore, as a rule of thumb, you should buy an aseptic filling system that features an efficient and reliable technology.
That is, go for the best filling, packing, sealing and sterilization technologies.
Let’s look at some of the recent innovations in this industry.
· Electron Beam Sterilization Technology for Aseptic Filling Machine
Quite a number of aseptic filling equipment use electron beam technology.
This is due to its efficiency and reliability.
Take a look at this video to learn more how Electron beam (eBeam or E beam) technology works.
So, what is electron beam sterilization technology?
It is a process where the aseptic filling machine uses beta radiation with high dosage rates and low penetration to sterilize products.
The ionization energy is produced in pulses or continuous beams to destroy microorganisms which may cause contamination.
Currently, it is one of the best sterilization technique in the industry.
Implementing electron bean sterilization technology is not as complex as you may think.
Only two electron beam lamps, you can sterilize both the outer and inner surface of the packaging container.
Electron beam technology
In case you want to learn more about e-Beam, here is an Electron Beam White Paper.
· Better Sealing Technology
Sealing is an important stage in the aseptic filling process, why?
It is at this stage the contamination may occur.
That is, if you’re not using the best aseptic filling system.
Of course, the type of sealing technology will depend on the type of product container you’re using.
Take for example, the sealing technology for vials, is different from that of ordinary bottles, Tetra Pack, etc.
Whichever option you go for, it must guarantee:
i. Zero contamination during the aseptic filling and sealing process
ii. Machine must not have direct contact with the product in the container
iii. Best sealing quality
In short, at any given time, your aseptic filling machine must guarantee a safe and reliable sealing mechanism.
· Touchscreen Human Machine Interface (HMI)
You need an aseptic filling machine with intuitive icons, fully integrated with robust and reliable PLC system.
Remember, to achieve the best sterilization process you should be able to monitor every stage of the process.
By minimizing human intervention, you can improve accuracy, reliability, and consistency of the aseptic process.
In fact, through the touchscreen HMI, you can monitor and change the parameters of the machine.
This is good news since it improves the reliability of the entire process.
It is an essential feature when it comes to achieving a seamless aseptic filling process.
However, it should be implemented in a manner that does not compromise the sterilization process.
Remember, a good machine should maintain the required sterilization standards from beginning to end.
It is a sure way to meet the set of international hygiene and safety standards.
· Maintain a high level of accuracy and consistency
An efficient machine should maintain accurate and consistent sterilization, alongside the filling process.
This way, you will save cost.
To achieve this, many aseptic filling systems feature a range of sensors to detect level, quality of the seal, and weight, among other critical aspects.
It should collect data and monitor the process for an optimal aseptic filling process.
· Servo motor for accurate capping
In modern control systems, servo motors play an instrumental role when it comes of both linear and angular position.
Unlike other motors, servo motors feature a control unit, dc motor gear reduction unit and position sensing equipment.
With servo motors, you should expect an accurate and consistent aseptic filling process.
· Advanced servo ball screw system
It is a unique transmission mechanism in most vial aseptic filling machines.
This system ensures accurate filling.
Furthermore, the aseptic filling machines also feature a high-precision splitter.
For intermittent feeding of containers, splitter guarantees the stability and accuracy of the aseptic filling process.
· Energy saving features
Reducing the cost of the aseptic filling process is the first step to remaining competitive in the global market.
A number of aseptic filling systems have features that reduce energy consumption.
Take, for instance, the servo control systems ensure precision and accurate filling process.
More importantly, the frequency converters ensure accurate speed control, thus saving on energy consumption.
Also, starting current for the aseptic filling machine is low.
Therefore, you don’t have to invest in heavy conductors.
The best part, even the power factor of the system is high.
Therefore, there is no need for modifications to improve the power factor.
· High-performance polyformaldehyde
It is a self-lubricating, heat and wears resistant.
A number of aseptic filling machine manufacturers use it in sections that are in direct contact with the packing material.
Even when the aseptic filler is in constant motion, it reduces possible wear.
In the long run, this feature reduces the cost of operating the machine and aseptic filler replacement parts.
· Advanced safety mechanism
Safety is an important aspect of any machine design.
It is for this reason that modern aseptic filling equipment features advanced safety features.
Fully enclosed system to prevent contamination
Some of the main modifications that improve safety include:
i. Implementing a servo motor system for accurate filling, minimize wastage, eliminate faults and guarantees reliable operation.
ii. Automatic overload protection – in case of possible overload, aseptic filling equipment will automatically stop the machine.
Also, the machine operator will see the faults on the touchscreen HMI screen.
iii. Simple and easy to use switching procedures give the operator full control of the machine in case of abnormal operation.
Operators can easily access the ON/OFF switch. Besides, in case of faults, the machine will not start.
As you can see, for optimal performance, you must buy an aseptic filling machine that features modern technology.
It is the only way you will be sure of:
- Accurate aseptic filling
- Precise container position
- Globally acceptable sterilization process
- Cost saving in the entire production process
Apart from these, you should review the technical specifications of aseptic filling machine.
It includes all production specifications, from aseptic filling machine size, accurate production capacity, power consumption, number of filler, etc.
Take a look at this:
This is a technical specification for automatic production line for aseptic eye drops.
As you can see, it states the very small details of aseptic filling machine.
Remember, this will form part of the technical manual of the machine.
But, technology is not the only thing you should review when buying aseptic filling equipment.
Quality compliance is an important aspect of the pharmaceutical equipment manufacturing process.
Quality Standards Aseptic Filling Process
Before you choose any aseptic filling machine or technique, it must conform to the necessary quality standards.
Implying, buying an aseptic filling that does not conform to the required quality standards is a waste of time and money.
At any given point, the aseptic filling systems must conform to:
· USP 1116
It stipulates a suitable environment when filling aseptic.
That is, the main focus is on Microbiological Control and Monitoring of Aseptic Processing Environments.
An aseptic filling equipment that conforms to these standards will obviously guarantee quality results.
Remember, unlike other industrial processes, with aseptic filling, having full control of the surrounding environment is fundamental.
CE marking, which standards for ConformitéEuropéene/European Conformity, is an important quality marking for pharmaceutical machines.
In fact, you cannot import or sell an aseptic filling machine that does not conform to the CE standards.
Although it applies mainly to the European Economic Area, it has been adopted globally as an important quality and compliance requirement.
Here is more information about CE Requirements.
· FDA Compliant
The Food & Drug Administration (FDA) plays a key role in ensuring safety and compliance in the pharmaceutical machines.
Apart from the machine design, FDA has approved various sterilization techniques such as the use of hydrogen peroxide and electron beam.
Of course, they have set the safety standards, and give clearance to aseptic filling machine manufacturers.
Clearly, that is an important step in ensuring safety and compliance in the industry.
The Current Good Manufacturing Practice (cGMP) outlines a set of rules and regulations that aseptic filling machine must conform to.
That is, from the choice of material, design to the working principle, they must adhere to some safety standards.
In fact, you should not buy aseptic filling equipment that is not cGMP compliant.
It refers to the Restriction of Hazardous Substances (Directive 2002/95/EC).
RoHS compliant aseptic filling machines do not have, produce or emit certain restricted hazardous material.
Implying, they are safe.
· EMA Compliant
The European Medical Agency (EMA) also works to ensure compliance of the pharmaceutical machines.
EMA helps in harmonizing standards of drugs, quality, and safety.
Of course, they have to ensure that manufacturers use the right machines and equipment.
Don’t get it wrong, please.
The fact that an aseptic filling machine manufacturer indicates that the equipment is cGMP, CE or RoHS compliant is not enough.
You should request for quality or test results.
In fact, you can work with a third party to ensure the machine conforms to the stipulated safety standards.
Apart from this, what else do you need to ensure your production line runs successfully?
Integrating Aseptic Filling Machine with Other Support Equipment
A good aseptic filling machine should allow for seamless integration with other machines.
As a matter of fact, after filling vials or ampoules, you may wish to package them.
Therefore, you should be able to integrate it with other secondary packing solutions.
A good example is the blister packing of vials.
Look at this:
Blister packaging of vials
To achieve this, you will obviously need a blister packaging machine.
Already, I have a good solution for you, just in case you need one.
Here is how to go about it: Blister Packaging Machine – An Ultimate Guide for Importers and Learners.
And of course, if your aseptic filling system is for an exporting or large production business, the process will not end at the packaging.
Also, you may need cartons.
That’s why you may need a cartooning machine.
Again, there is a helpful guide for that here: Cartoning Machine – The Ultimate Buying Guide.
With the two equipment, you will successfully operate your aseptic filling business.
Now, assuming you want to buy an aseptic filling machine today.
How should you go about it?
Well, you need a User Requirement Specification (URS). Let’s talk about that.
URS for Aseptic Filling Machine
User Requirement Specification for Aseptic Filling Machine is a document that details your business needs.
As earlier mentioned, there different designs of aseptic filling machines.
Therefore, you must specify what you intend to do with the aseptic filling equipment.
So, who writes the URS for aseptic filling machine?
It is teamwork which includes:
i. End user, which in this case is you (assuming you want to buy an aseptic filling machine)
ii. Aseptic filling machine manufacturer – they know every detail of their machine, and whether they can modify it for your specific needs.
iii. Quality assurance team – their input plays a critical role in aseptic filling machine URS
Since URS for aseptic filling machine is a detailed document, here you will only learn about the key components.
Aseptic pouch filling machine
A good User Requirement Specification for Aseptic Filling Machine must include the following:
i. Purpose, general description, and scope of the aseptic filling machine
ii. Aseptic filling machine specification
iii. Plans and documents of aseptic filling machine
iv. Aseptic filling machine sample tests
v. Factory acceptance tests for aseptic filling machine
vi. Site acceptance tests for aseptic filling machine
vii. Commissioning of aseptic filling machine
viii. Validation of aseptic filling machine
ix. Training personnel for the purpose of operating aseptic filling machine
x. Quality standard documents for aseptic filling machine
xi. Aseptic filling machine export packaging, insurance, and protection
Honestly, making URS of aseptic filling equipment can be a demanding process.
But you must be keen and cooperate with the manufacturer to get the best equipment.
SaintyCo Aseptic Filling Line
SaintyCo is a global leader in designing and manufacturing aseptic filling machines.
With years of experience in manufacturing pharmaceutical machines, SaintyCo adheres to strict quality control and standards.
SaintyCo aseptic filling machines are all-in-one equipment that sterilizes, fills, seals and inspects finished products.
SaintyCo aseptic filling lines feature modern sterilization techniques, safety and energy efficiency.
The machines are highly adaptable and flexible for a range of aseptic filling process solutions.
In short, you can count on SaintyCo when it comes to aseptic filling solutions.
As you can see from this guide, choosing the right aseptic filling machine, container/packaging solution, focusing on technology and knowing your production needs will guarantee success in this industry.
Clearly, this guide covers every aspect in a detailed and simple way for you to understand.
It doesn’t matter the type of aseptic filling machine you’re looking for, with this guide, you will get what you need.
Still, our team is always ready to help you get the best accessory.
You can contact us today, for free consultations or ask questions about the aseptic filling machine.
- Aseptic Processing and Packaging for the Food Industry – Source: FDA
- New vs. Traditional Aseptic Processing – Source: PDA
- Blow Fill Seal in Aseptic Filling – Source: Pharmtech
- Aseptic Processing – Source: Wikipedia
- Aseptic Filling Process – Source: Pharmaceutical Guidelines
- Keys to Aseptic Processing – Source: Pharmaceutical Online
- Aseptic Processing and Fill – Source: Science Direct