Softgel encapsulation machine plays an integral role in ensuring the soft gelatin capsules improve the bioavailability of nutrients or specific elements of a drug.
The three pharmaceutical machines play an integral role in transforming materials into appropriate dosage forms.
In this buying guide, you are going to learn about all the critical aspects of soft gelatin capsule filling machines. It will cover the following key areas:
- What is a Softgel encapsulation machine?
- Why should you adopt Softgel encapsulation process?
- Parts & components of soft gelatin capsule filling machine
- Working principle of Softgel encapsulation equipment
- Technical specifications of Softgel equipment
- Quality testing standard of good Softgel Equipment
- Where to buy Softgel encapsulation machines
With this information, you should be able to make an informed decision whenever you’re shopping for this vital accessory.
Let’s dive right into these 7 aspects in details:
1. What is a Softgel Encapsulation Machine?
A Softegel encapsulation machine is an electromechanical accessory that fills hermetically sealed gelatin shells (that exist in one piece) with semisolid, liquid or suspension.
The content of the soft gelatin capsules could be active ingredients with different excipients depending on the specific dosage requirements.
For instance, you can use the Softgel encapsulation equipment for oral or suppository dosage form. At times, you can use them for special package.
Basically, Softgel encapsulation equipment in an assembly of parts and components that coordinate to fill and seal the soft gelatin capsules. Below is a complete assembly of soft gelatin capsule filling machine:
As you will see later in this guide, you will realize that the working principle of these soft gelatin capsule filling machines is quite unique and different. The capsule filling process may take the form of a plate or a rotary die process.
But, why should you adopt or buy a soft gelatin encapsulation machine?
This will now take us to the cornerstone of this guide:
2. Why Should You Adopt Softgel Encapsulation Process?
I know this is the first question that will cross your mind.
At times, you may have no choice but to opt for soft gelatin capsule encapsulation process, especially when you wish to achieve the following:
- Produce easy to swallow capsules more so, in situations where the recipient cannot use ordinary capsules or tablets.
- Ensure active ingredients are stable, thereby increasing their shelf life.
- Enhance the bioavailability of certain nutrients or active ingredients in capsules
- Guarantee greater accuracy in dosing
- Fill capsules with liquid or suspension
- Produce capsules with flexible shapes
- Make capsules that are resistant to temperature and heat fluctuations
- Better customization; you can produce virtually any shape depending on the design and shape of the die cavity
- Hermetically sealed; makes soft gelatin capsules tamperproof and air tight
In such situations, your options may be limited to Softgel encapsulation process.
So far, Softgel encapsulation process is one of the most flexible and adaptable in both food processing, chemical manufacturing and pharmaceutical industries.
As you will realize later in this guide, the modern Softgel encapsulating equipment fully integrates all the essential components into one machine.
That is, from gelatin preparation, fill material preparation, encapsulation, drying, cleaning and inspection processes.
Of course, this will depend on the model of the Softgel encapsulation machine too.
The bottom line is that, whenever you wish to fulfill the above criteria in your oral dosage, then Softgel encapsulation process will be the most appropriate.
To achieve this, you must choose high quality and reliable encapsulation machine. This is exactly what you’re going to learn in this guide.
Now, let’s start off by exploring the various parts and components of soft gelatin encapsulation equipment.
3. Parts & Components of Soft Gelatin Capsule Filling Machine
First of all, it is important to note that soft gelatin encapsulation machines come in a wide range of shapes and sizes. Therefore, it is common to find a machine with more parts than others.
For the scope of this section, our main focus will be on critical parts and components that are common in most machines available in the market. Therefore, this will only act as a guideline to give you a quick overview of what you should expect.
As a rule of thumb, before you buy any encapsulation machine, it is vital to review the user manual or product catalogue. This way, you will know any part that may be unique to a specific Softgel encapsulating machine model or brand.
Below is a diagram of SaintyCo Aprila SG200 Medium Scale Soft Gelatin Capsule Filling Machine. It shows some of the most critical components and parts of this encapsulation machine:
Now, let’s go straight to these parts and components:
Product Material Tank/Medicine Hopper
This is a stainless steel container that holds material you would wish to encapsulate in the soft gelatin. In most cases, this part is found in the upper section of the machine.
In the diagram above, this part is labeled as part (1).
The design of a product tank or medicine hopper should be such that it allows material to flow seamlessly into the pump. As a result, the design can be conical or any other shape with slanting sides towards the pump.
Furthermore, to prevent any possible contamination, the medicine hopper should have a lid, with a handle. Besides, there must be no leakages at the point it joints other section of the machine.
Material Feeding Pump
As you can see from the image below, the material feeder pump is just above the frame but below the hopper. Hence, it makes it easier for the feeding pump to suck material from the hopper and directs it to the next stage through the feed tubes.
The material then flows to the injection wedge, while the excess flows back through the return pipe/tube (see image above) to the hopper. At any given point, the machine automatically monitors the material feeding pump pressure to prevent its tubes from busting or causing unnecessary leakages.
Remember, the Softgel encapsulating machine frame is made from stainless steel and it supports all the components.
From the first image in this section, you can see the exact location of the injection wedge (2). It is just above the Softgel encapsulation machine tooling system.
As you can see from the image below, this is name is basically due to its geometrical shape.
Below are critical aspects you need to know about this component:
First, it is this injection wedge that heats the web to a suitable temperature, while injecting fill material on the web as they move to the die cavity of the two rollers. Of course, material flows through the injection wedge due to the pressure from the pump system.
Furthermore, the wedge may have an electric or water heating system.
Second, the complexity of the injection wedge will depend on the design of Softgel encapsulation machine. For instance, the wedge module may:
- Have sensors to coordinate its motion
- Come with shut off valve systems
- Move up & down
Remember, it is the injection wedge that determines the accuracy of the Softgel encapsulation process.
Gelatin Melting and Mixing Tank
This is where the preparation of gelatin material takes place.
Most noteworthy, this is a stainless steel tank that comes in different capacities depending on the production needs of the machine.
It has steel valves, clamps and triple wall jacket with a breather. Below is the gelatin melting and mixing tank for the SaintyCo Softgel encapsulation machine.
Whenever you are choosing a gelatin melting and mixing machine, you should consider the following key specifications:
- Type of materials where stainless steel is a perfect choice
- Volume or capacity of the tank
- Power rating
- Working temperature
- Size; both weight and dimensions
Gelatin Spreader Box
Once the molten gelatin leaves the melting and mixing tank, it is the spreader box that holds and spreads it into a thin film.
Normally, the design of Softgel encapsulation machine is such that it has two spreader boxes on both sides of the machine. That is, there is the right and left spreader box.
Its location is just above the machine’s cooling drum.
Under normal circumstances, the casting drum rotates parallel to a controlled gap, that is, between the cooling drum and spreader box.
It is this action that forms ribbon shells. In most cases, their thickness can be about 800µm thick with a 150 mm width.
Remember, this size may vary depending on the specific applications, i.e. type of soft gelatin capsules.
Cooling Drum of Softgel Encapsulation Machine
Like the spreader box, most Softgel encapsulation machines have the right and left cooling systems.
It is this drum that cools and solidifies the gelatin web. The two drums are always in constant rotary motion in the direction where the gelatin web should move towards.
You can see the location of the cooling drum in the image above (the section that explains gelatin spreader box).
Normally, the cooling drum of a soft gelatin encapsulation system may adopt different cooling mechanisms. These may include:
- A cooling fan; this fan helps to cure the gelatin web, making it ready for encapsulation.
- It may use clean water that circulates to cool the gelatin web ready for encapsulation process
In addition to these, the machine may have a chilling or a refrigeration system. This helps to keep the temperature of the gelatin skin wheel at a specific temperature.
Whenever you are shopping for a Softgel encapsulation machine’s chilling system, you should consider the following:
- Dimensions and weight
- Power consumption
- Refrigeration capacity
All these parameters will depend on the design and specific shapes of the machine.
From the cooling drum, the gelatin web should move towards the tooling system of the machine. This now takes us to another important part of the soft gelatin encapsulation machine:
Lubrication Rollers or Oil Rolls
The modern Softgel encapsulation equipment have at least 3 rollers. This ensures the gelatin web or ribbon reaches the Softgel tooling system when it is tight.
Again, you can see the exact location of the oil rolls (section explaining gelatin spreader box).
Besides, the lubrication rollers apply lubrication solution on both sides of the web. This protects the gelatin skin from any possible damage during the process.
The lubrication solution should be safe and must not react with either the gelatin material or the capsules.
Otherwise, this can be detrimental.
Next, we have the:
Tooling System of Softgel Encapsulation Machine
The design of Softgel encapsulation equipment is such that there are two die rollers. As the die rolls rotate, they form the individual soft gelatin capsules, while sealing them after filling.
This soft gelatin encapsulation process is such that, the material from the two opposite sides move into the space between the two die rolls.
As you can see from the tooling system above, the die rolls have die pockets.
During this process, the gelatin ribbons and paste or liquid fill is continuously fed between the two rotating die systems.
Here, a number of processes take place:
- Continuous feeding of gelatin ribbon or web and subsequent filling
- Shaping of the capsules
- Hermetically sealing the filled capsules
- Cutting capsules from the soft gelatin ribbon
Furthermore, during this process, the systems exerts mechanical pressure on the dies rolls as the wedge heats the gelatin ribbon to a temperature of about 37 to 40°C.
Another critical component of the Softgel encapsulation machine tooling system is stripper roller.
You can see the exact location of the stripper roller in the diagram above (refer to gelatin spreader box image). A stripper roller removes any capsules that may be on the soft gelatin web.
In addition to these, these encapsulation machines have the die roll brush.
During the soft gelatin encapsulation process, its work is to remove any capsules that may stick on the die rolls. A machine may have one or two die roll brush, which are in constant motion.
In most cases, the rotation of the die rolls brush tend to rotate in the opposite direction to that of the individual die rolls.
Again, you can see the location of the discharge chute in the image above (refer to gelatin spreader box image). All hermetically sealed capsules leave the chute through this system to the conveyor belt.
The conveyor belt safely transfers the delicate Softgel capsules for further processing. This includes drying, inspection and sorting.
In addition to these parts, the Softgel encapsulation equipment feature mangle rollers that pull the Softgel web from the main die rolls.
By doing so, it adjusts the tension of the Softgel web besides discarding it for further recycling.
From the capsule encapsulation process, the conveyor system directs the final product to the drying system. Here, we have two options:
- Tumble dryers
Their design is to provide an easy and simple drying mechanism for the soft gelatin capsules.
Some of the key issues to consider include:
- Number of tumble dryers
- Dimension of tumble dryers including weight, dimension and size
- Power supply
Normally, the Softgel capsule will remain in the tumble dryers for some time before transferring them to the drying trays.
- Drying tray
From the tumble dryers, Softgel capsules are taken to drying tunnels using these trays. The drying trays come in different dimensions (width and length).
Quite a number of soft gelatin encapsulation machines have Siemens PLC systems. This makes it easy to control and monitor various operations of the soft gelatin encapsulation process.
Through the control panel, operators can monitor and control all processes in this machine. The control panel is part (8) of the first diagram in this section.
In short, these are the main parts and components of the Softgel encapsulation equipment.
Of course, there are other components within the main body or other accessories. You can learn more about them in the product manual or catalogue.
With all these in mind, let’s quickly go over another critical aspect you must know before buying any Softgel encapsulation equipment.
4. Working Principle of Softgel Encapsulation Equipment
From Section 3 of this Softegel encapsulation machine buying guide, you had an overview of how various parts of this equipment function.
Basically, by discussing every part in details, it clearly gives the basic foundation of the working principle of soft gelatin encapsulation equipment.
For the scope of this section 4, we’ll quickly go through a step-by-step process on how these capsule encapsulation machines work.
Broadly, we can summarize the working principle of capsule filling machine as:
- Preparing gelatin
- Fill material preparation
- Encapsulation process
- Further processing of soft gelatin capsules
Let’s now focus on each of these points in details:
Step1: Preparing Gelatin
You must choose the correct formulation for gelatin. In most cases, they are made of:
- Gelatin which is basically a protein substance that you can obtain from boiling bones, skins, tendons, etc.
- Plasticizer; they may the shell pliable and elastic.
- Water; this plays an integral role in Softgel capsule preparation and encapsulation processes
Remember, it is this gelatin that will be the outside barrier of the capsules. This is the reason why you must choose a suitable formulation.
With the correct formulation, you can prepare gelatin in the melting tank (see section 3 to learn more about this section).
During this stage, you will blend and heat all the ingredients as you stir to ensure they form thick syrup.
The syrup will then flow to the spreader box, cooling drum and then to die roller system. Remember, at every stage, the machine controls motion and parameters for an optimal production.
In short, this forms the first phase of any Softgel capsule manufacturing process.
The next critical stage in the working principle of Softgel capsule filling machine is the preparation of a fill material.
Step 2: Fill Material Preparation Process
Can you remember the exact location of the hopper?
Well, you can review section 3. It will remind of the critical parts and mechanism through which the fill material flows from the hopper through the tube into the injection wedge system.
It is a simple process in Softgel capsule production process.
Depending on the specific content of your soft gelatin capsules, you can process it to form oil-based or paste like product.
Once you make an appropriate fill material it will flow from the hopper to the injection wedge system as I had mentioned earlier.
Step 3: Softgel Encapsulation Process
This is yet another critical stage in the working principle of Softgel capsule filling machine.
At this stage, the Softgel encapsulation machine brings both the fill material and gelatin together.
Below is a video showing how SaintyCo Softgel encapsulation machine works:
The two ribbons move into die rolls system (they are always in a rotary motion) and this creates a unique shape of the capsules. At the same time, the machine administers the fill material between the gelatin ribbons within the die rolls.
The gelatin wraps the fill material forming a custom made capsule. Its shape will depend on the cavities of the die rolls.
The capsules will then leave the machine via a discharge chute as the brush removes any capsules that may stick on the die rolls.
Besides, the stripper rollers will also remove and capsules on the gelatin web.
Normally, this is a continuous and fast process.
Step 5: Further Processing of Soft Gelatin Capsules
This is the last stage of Softgel capsule production process. Once the Softgel capsules leave the discharge chute, they will go to other processes such as drying, cleaning and sorting.
In most cases, the conveyor belt will take all the Softgel capsules to the tumble dryer. They will remain in the dryer for some time before being transferred to the drying tunnels in trays.
Again, section 3 has all details on how tumble dryers and dry trays look like. You can review that section.
Remember, the drying system or sorting machines are auxiliary components of the Softgel encapsulation machine.
As you can see, the working principle of Softgel capsule filling equipment is simple and straightforward.
Importantly, you should read sections 4 as you refer to section 3 since it has vital information about how key components work. Of course, all these form an integral part of the working principle of a soft gelatin encapsulation machine.
With all these in mind, let’s now classify the available soft gelatin encapsulation machines.
5. Classification and Types of Softgel Encapsulation Equipment
Unlike the hard shell capsules where you can use the manual capsule filling machines, here the systems are fully automated. That is, as the soft gelatin material enters the die system, the machine injects the fill material.
Therefore filling and sealing of soft gelatin capsules take place simultaneously.
Now, when it comes to the classification of different kinds of Softgel encapsulation machine, I will use simple criteria. That is, classification by:
- Production capacity
- Type of soft gelatin capsule
Let’s have a quick overview of these types of encapsulation machines:
Types of Softgel Encapsulation Machines Based on Production Capacity
Generally, we can classify all the available soft gelatin encapsulation machines into the following three main categories:
- Small scale capsule filling machines
They are generally small in size (i.e. portable). In most cases, you will find these machines in laboratories or R&D institutions.
By design, they can only produce a small number of soft gelatin capsules. A good example of small scale capsule filling machine is the SaintyCo Aprila SG50 R&D Soft gel Encapsulation Machine.
- Medium scale Softgel Encapsulation machines
The production capacity and size is neither high nor low. This makes them a perfect choice for institutions that produce medium scale soft gelatin capsules.
SaintyCo Aprila SG200 Medium Scale Soft Gelatin Capsule Filling Machine is one such example of medium scale capsule filling machine.
- Large Scale soft galetin encapsulation machine
As the name suggests, these types of capsule filling machines are suitable for large scale production. You will find them in food processing or pharmaceutical industries.
A good example is the SaintyCo Aprila SG250 Large Scale Soft Gelatin Encapsulation Machine.
Classification Depending on the Shape and Size of Soft Gelatin Capsule
The shape, size or design of soft gelatin capsule will depend on the die roll. You can either go for the standard designs or opt for custom made options.
Even if you go for the custom made capsule filling machine, it takes only 2-weeks to get a custom made Softgel tooling. Moreover, depending on the design of Softgel encapsulation machine, you can easily change the tooling system.
Some of the most common capsule sizes and shapes include:
- Oblong Soft Gelatin Capsules
- Round Soft Gelatin Capsules
- Oval Soft Gelatin Capsules
- Tubs Soft Gelatin Capsules
Apart from these, others tend to classify different kinds of Softgel encapsulation machines depending on the model, structure, material etc.
Another critical aspect whenever you are buying a soft gelatin encapsulation machine is the technical specifications.
That is exactly what you will learn in section 6 of this guide.
6. Technical Specifications of Softgel Equipment
It is from the technical specifications that you will know the performance characteristics of a capsule filling machine.
It is from these specifications that you can tell whether the machine is suitable for your unique capsule filling needs or not.
Before you buy a Softgel encapsulation machine, it is important to consider the following key technical specifications:
- Production capacity or estimate; this is the number of capsules a machine can produce within a specific timeframe.
- Shape and size capsules
- Number of tumble dryers
- Dimensions (length, width and height)
- Average weight
- Noise level
- Power consumption/requirements
- Type of material
- Model of the machine
From this information, you can tell whether the machine is suitable for any capsule filling process. Below is an example of a technical data from SaintyCo Aprila SG250 Large Scale Soft Gelatin Encapsulation Machine.
Apart from the technical data of the Softgel encapsulation machine, you must know the technical information of any auxiliary system you intend to use alongside the capsule filling machine.
Take for instance, for a gelatin melting system, below are some of the key factors you must consider:
By doing this, you will obviously plan for your capsule filling with a view of profiting from the entire process.
In addition to these, you should also consider other features that improve performance. These may include, automation, safety, power saving, accuracy, lubrication, cost effectiveness, etc.
Even as you go about all these processes of knowing soft gelatin machines, there is a critical factor one must never forget. That is, whether the machine meets the set quality standards or not.
Here are a few facts you need to know about the quality standards of Softgel capsule filling machines.
7. Quality Testing/Standards of Good Softgel Encapsulation Machine
Every soft gelatin capsule filling machine must meet certain quality standards. This is to ensure the machine remains safe and guarantee optimal performance.
Therefore, before you buy any Softgel encapsulation machine, it is important to confirm whether it conforms to the stipulated quality standards or not.
Below are a few factors you should consider:
Capsule Filling Machine that is CGMP Compliant
The U.S. Food and Drug Administration has strict rules and regulations, which stipulate that every pharmaceutical machine must conform to the CGMP standards.
It is for this reason that you will find manual, semi-automatic and fully-automatic capsule filling machine made from stainless steel. This is mainly for parts that are in direct contact with the product.
Furthermore, the CGMP regulations ensure that the Softgel encapsulation machines are:
- Easy to clean and maintain; when it comes to maintaining the hygiene of the capsule filling machine.
- Better dust handling capability, thereby reducing any possibility of environmental pollution.
- Materials for the structure, joints and parts should be FDA approved materials.
- Feature advanced cleaning and safety procedures
To learn more about this, you can read my previous article on: The Importance of CGMP and GMP Requirements in the Pharmaceutical Industry.
Environmental Compliance Regulations
This is another aspect that you must consider whenever you are buying any Softgel encapsulation machine.
The machine must meet all the necessary environmental regulations. Therefore, it should be a machine that:
- Produce low noise during the encapsulation process
- Use little lubricant for its gelatin ribbon sheet
- Stable and cost effective cooling system
- Low amount of waste material, just to mention a few.
In addition to these, the soft gelatin capsule filling machine should be CE compliant and ISO certified. Besides, the machine should also fill the standard sizes of soft gelatin capsules alongside the custom options.
Basically, by observing quality, there is a high chance that you will optimize all capsule filling operations in your industry.
That being said, let’s quickly review where you can buy these soft gelatin capsule filling machine.
I believe at this juncture, you can now evaluate the most critical parts, working principle and obviously, know the exact reasons why you need Softgel encapsulation machines.
8. Where to Buy Softgel Encapsulation Machines
I will not lie to you:
Buying soft gelatin capsule filling machines from Chinese manufacturers is a noble idea. This is because of the Chinese companies offer cost competitive rates for their capsule filling machines.
Besides, the Softgel encapsulation machines feature both the European and American technologies, alongside their own patented technologies. Therefore, this results in a robust and effective encapsulation machines that meet most capsule manufacturing needs.
The companies offer better technical support alongside the easy to use documentation that every machine comes with. Even the European and American sellers have OEM partnerships with the Chinese capsule filling machine manufacturers.
Here at SaintyCo, we design and manufacture a wide range of soft gelatin capsule filling machines from R&D to mass production. This is also alongside the Softgel support equipment.
Both the machines and support equipment come in both standard and custom options. It takes no more than 2 weeks to make a custom Softgel tooling system.
From this Softgel encapsulation machine buying guide, it is quite clear that you must know the reasons why you need the machine, basic parts, working principle, types of machine and quality regulatory standards.
Besides, identifying the best capsule filling manufacturer is also very important. With all these information, you can easily choose a high quality and reliable machine that will guarantee a high return on investment.
For any queries or free consultations on the different types of capsule filling machines, feel free to contact our technical team today.
- Softgel – Source: Wikipedia
- Progress & Challenges in Softgel Capsules Formulations – By H.I. Benza & L.L. Munyendo
- Types & Sizes of Capsules for Automatic Capsule Filling Machine – Source: SaintyCo
- Components of Softgel Encapsulating Machine – Source: Pharm Approach