Understanding The Softgel Drying Process & How To Make Yours Better
Considering the need for many people to be able to take their pills at a go, it is almost impossible to overstate the importance of softgel capsules. These capsules provide a better alternative to their hard counterparts, making it much easier for people to take drugs and medicines.
However, for these pills to be made, one of the most important steps comes when heat is applied to them. We’ll take you through what this entails and how it is done in this piece.
Softgel: How Is The Material Made?
We all know those soft and squeezable pills that we take. These oral dosage variants are popular because of how easy it is to ingest them – especially compared to the harder variants.
A softgel capsule comes primarily with a gelatin-based shell that covers a fill material.
Now, what material is softgel? Generally, you find them containing different components – from water to gelatin and any other additives that the manufacturers might believe will help optimize the efficiency. See that soft and flexible outer body? That’s the gelatin you’re feeling!
The Softgel Encapsulation Process
At this point, understanding softgel basics shouldn’t be much of a problem. However, it is important for you to understand just how these materials are developed generally:
Before a softgel pill can go to market, manufacturers need to get the proper combination of ingredients and additives that will be placed within the pill to make it useful to anyone who takes it.
Once you have the shell done, you can cool the solution and form it into a gelatin sheet or ribbon.
Fill Material Preparation:
Next, you go ahead to prepare the fill material by mixing all of the active ingredients together – as well as possible additives and excipients that might be present in it.
This entails taking the derived ribbon and feeding it into a rotary die encapsulation machine. Most of these machines come with two rotating dies, which come together to form a perfect seal.
As the dies rotate, cavities are created. The fill material that’s been developed will then be pumped into the encapsulation machine, where it will be distributed evenly into the cavities that are created.
All in all, the primary objective is for you to squeeze out any excess moisture from the pill.
Quality Control & Inspection:
Prominent quality control checks include visual inspection to examine possible defects and testing to determine content uniformity and fill weight.
Printing & Packaging:
Once done, the capsules are packaged into the right containers and are sent out for sale and distribution.
Why Bother With Drying In The Process?
Make no mistake – considering the importance of these products, every single step that goes into making them is important. However, drying is unarguably one of those processes that just need to go right. Here’s why:
Moisture Content Control:
Most importantly, it is worth looking at why you’d want to take a capsule and dry it in the first palace; to remove excess moisture.
The presence of excess moisture will affect the quality, stability, and overall shelf life of the capsule. So, by taking it out, you reduce the risk of microbial growth, material degradation, and possible changes in the shell material or active ingredients found in the capsules.
Appearance and Quality:
A key reason why many people find it easy to take capsules is because the capsules themselves look appealing. And, this process also helps with that.
With excess moisture, you run the risk of your capsules appearing cloudy and developing moisture droplets on its surface. If the moisture gets too excessive, the casuals could even become sticky over time.
Drying helps to ensure that you never have to deal with these issues, resulting in capsules that have a smooth and uniform look. This contributes to the overall aesthetic appeal and appearance of the product.
For most manufacturers, the goal is always to strike a perfect balance between functionality and aesthetic appeal. We already spoke on how drying affects the latter, but we should also consider its effects on the former.
When moisture soaks into a capsule’s material, it becomes even softer and more susceptible to brittleness. Fortunately, proper drying ensures that the capsule holds its properties and can go from the factory to the consumer without degrading.
As capsules move from manufacturer to consumer, there is a lot of logistics involved. And, during this step, a lot of things happen that could affect the pill’s overall properties. By drying softgel capsules, you can create a more supporting environment for the pills to be properly handled.
You don’t want the capsules to stick, form clumps, or even get deformed as these issues will make packaging and handling especially challenging. Drying helps ensure this.
Now, we should point out that you want to be careful with this process in general. Focus on maintaining optimal drying levels and to avoid overdrying – which can also make your product more brittle and reduce its volatile ingredients.
At Sainty Tec, we can help provide insights on the best softgel drying process for you as well as how to go about it.
The Softgel Drying Process
We already covered the importance and purpose of softgel drying. Now, it’s time to examine how the process works and the ways you can achieve it:
The Drying Stage In Softgel Manufacturing
Next, let’s find a proper breakdown of the softgel drying process for a better understanding.
Softgel Formation and Filling:
We already touched on the softgel manufacturing process for the capsule. The fill material, whether in the semi-solid or liquid formulation, is injected into gelatin-based shells with an encapsulation machine.
Transfer to Drying System:
Now, you get a glimpse of what the actual drying looks like. The capsules need to be properly arranged on racks or trays, and it is important to ensure adequate spacing for sufficient circulation of air.
Initial Drying Stage:
You begin the drying process of softgel manufacturing process by focusing more on the outer part. In this stage, you raise the temperatures considerably, reducing humidity levels in order to facilitate the evaporation of moisture that’s present on the capsule’s surface.
Just as well, the optimal circulation of air will help ensure an even distribution of heat and take out any excess moisture.
Gradual Reduction of Temperature and Humidity:
With the progression of the drying process, you can begin to drop temperature and humidity levels gradually.
The importance of this process is simple – beyond just the surface, you also want to make sure that the moisture removal gets to the core of your pills. And, you still want to make sure that the capsules aren’t affected in any way.
Monitoring and Control:
It is also important for you to keep a constant eye on the humidity and temperature levels as the process continues to progress. To do this, the first box you want to check is getting an automated system or operator. This ensures that all conditions necessary for optimal drying are present – and present in the required ranges.
With this, achieving the proper rate of moisture removal will be easier. And, you also get the benefit of not necessarily contributing to any reduction in the capsules’ material properties.
Drying Completion and Cooling:
As soon as you’re able to achieve the perfect moisture content levels, you know you’re getting to the finish line. But, things aren’t done yet.
The next step will be to take the softgel capsules and cool them down. With room temperature the capsules don’t run the risk of being condensed, and you will also find it much easier to package and handle them for external movement.
Inspection and Quality Control:
Now that you’re done with cooling and packaging, you can give the capsules a final look. Remember the importance of quality control – from visual inspections to additional testing for content uniformity and fill weight.
Each of these steps will ensure that the capsules meet the required standards.
As always, you want to keep in mind that some details of each step in the overall drying systems for softgels can vary based on a number of factors – from the equipment being used to the production scale and more.
Still, always keep in mind that you can reach out to us if you need more information that can guide your overall process.
Drying Methods Used In Softgel Manufacturing
Now that you have a clear understanding of the overall workflow that goes into softgel drying, the next step will be to look into some of the different techniques that can be implemented to ensure that this step goes off like clockwork. So, how do you dry soft gel?
As for which drying method is used in soft gelatin capsules, the selection of a drying process will depend on several factors – such as the formulation characteristics, the required moisture removal rate, ingredient sensitivity, and even the available equipment at the manufacturing facility.
That said, here are drying techniques you want to keep in mind:
- Convection Drying: In the convection drying process, we use hot air to take out moisture from the softgel capsules. The capsules are essentially put in a drying chamber or oven, and heat is applied.
Hot air is circulated around the capsules, with the heat causing the moisture to evaporate entirely. With air circulation, moisture is taken out gradually. With optimal effectiveness and ease of implementation, convection drying has become an especially popular drying method for capsules.
- Vacuum Drying: Vacuum drying is quite similar to the method above. However, here, moisture is taken out thanks to reduced pressure or vacuum conditions. With pressure being lowered, you get to reduce the boiling point of water, causing quicker evaporation – even at low temperatures.
The softgel capsules are placed in a vacuum chamber, and the pressure of the surroundings is cut significantly. In some cases, heat is also applied to optimize the drying process. In cases where you have moisture-sensitive materials, vacuum drying is the preferred choice.
- Freeze Drying (Lyophilization): This is a specialized drying method that is used for heat-sensitive materials. For this process, you begin by freezing the softgel capsules and dropping their temperature significantly. From there, a vacuum is applied, with the moisture undergoing sublimation and moving from ice to water vapor.
The lyophilization process is prominent because it is more gentle – while still preserving the softgel capsule’s properties and overall content. It is also used for temperature-sensitive capsule formations, and it is preferred for its speed and efficiency.
- Infrared Drying: With infrared frying, you make use of infrared radiation to directly transfer heat to the softgel capsules. In this method, infrared lamps emit the required radiation, which the capsules sock in and use to eliminate excessive moisture.
Infrared drying can also be quite quick and efficient since the heat is absorbed by the softgel capsules. This means that heat oss to the environment can be minimized significantly.
Parameters and Considerations In Softgel Drying
As far as this critical process is concerned, there is no overstating the importance of several parameters:
Moisture Content Specifications:
First, you want to know how much content needs to be in your capsule formation. Establish this metric based on the specific product requirement and formulation details, and be aware of it as you go forward.
In most cases, the moisture content specifications will vary based on factors such as the gelatin shell’s integrity, the stability of available active ingredients, and how much you intend for the product to last.
Drying Time and Temperature:
Next, you want to set out the temperature and drying time parameters. Both will play an important role in achieving optimal moisture removal, while also limiting any negative effects on the capsules themselves.
Prolonged drying times or excessive heat can lead to product degradation and even a loss of critical components. Just as well, insufficient drying will defeat the entire purpose of the process in the first place and compromise the quality and stability of the capsules.
Maintaining a watchful eye on the humidity levels during the drying process is very important. If humidity is too high, the evaporation of moisture can be slower, leading to longer drying times. Conversely, low humidity levels can cause the capsules to over-dry, leading to material brittleness and increasing the risk of deformations.
Optimal humidity should be the objective here as it will promote reliable and controlled moisture removal.
This metric is critical – especially within your setup – as it helps ensure that the benefits of your operation are uniform across all capsules. This is why you need properly designed equipment from Sainty Tec to ensure that heated air can be properly distributed, ensuring that all capsules receive the right amount of drying.
Drying Equipment and Validation:
Your choice and validation of the necessary drying equipment should also not be taken lightly. In general, your drying equipment should be able to provide enough and controlled drying conditions necessary to achieve the right moisture content.
Remember that manufacturers will need to validate the drying process and equipment to ensure reliability and compliance with existing regulations.
At all costs, you want to prevent the over-drying phenomenon. This ensures that product brittleness can be avoided and sees to it that no volatile components are lost.
All through the drying process, watch and control the parameters to ensure that you don’t over-dry the capsules. And, as part of your quality control checking, be especially aware of this.
By considering these important factors, you can ensure that your capsules are in the best shape, and that moisture can effectively be removed from their surfaces and inner areas.
Overall Softgel Drying Equipment & Technology
For efficiency to be ensured across the board, you’d really only be as good as the equipment at your disposal.
Critical Drying Equipment & Technologies
Below are some of the most important ones:
Drying Chambers or Ovens:
You can choose either of these as you embark on the drying process. Whatever you choose, its objective is to provide a controlled environment where you can conduct your drying once and for all. The capsules are placed on racks, with the chambers having heating equipment and ventilation systems where temperature and humidity can be controlled.
Depending on the drying technique you use, it’s important to have the right systems:
- Convection Drying Systems: This system usually consists of a drying chamber or conveyor belt, as well as blowers or fans that circulate the heated air throughout the chamber.
- Vacuum Drying Systems: In this system, you usually have a vacuum chamber where the capsules are placed. Once pressure inside the chamber is reduced, moisture evaporation can be done easily.
- Freeze Dryers (Lyophilizers): In freeze drying, you need lyophilizers that help to freeze the capsules at low temperatures and subject them to the vacuum to induce sublimation.
- Infrared (IR) Drying Systems: This system uses infrared emitters or lamps to emit the desired radiation, which the capsules then absorb, causing moisture evaporation.
Automated Drying Systems:
An automated drying system will incorporate advanced monitoring and control features to ensure that drying is optimized. From feedback loops to sensors and programmable logic controllers, the goal here is to regulate all drying parameters to ensure that the process is as optimal as possible.
Moisture Monitoring Equipment:
Lastly, you can get analyzers, moisture meters, and other monitoring equipment to measure the moisture content of the capsules during and after the overall drying process.
These devices offer reliable and precise measurements, ensuring that you can achieve the desired moisture content specifications.
You should note that in some cases, different combinations of these equipment and technologies can be employed based on your specific needs and product requirements. Choose what you feel will help you to optimize the process as much as possible, and don’t forget to ensure safety as well.
Considerations for Selecting appropriate Drying Equipment
There is no doubt that you want to select the ideal drying equipment for your softgel capsule products. However, while this is true, it is also important to keep some of the following factors in mind as you work:
- Drying Capacity: Be mindful of the desired production capacity and throughput. Always choose equipment that can handle your expected volume efficiently without compromising on the process.
- Drying Method Compatibility: When you decide to get the proper equipment for your drying process, you don’t just go into the chamber and begin. Instead, look into the methods that each component is ideal for, as well as whether your chosen methodology falls into the scope of each equipment.
- Drying Control and Monitoring: If there is one thing you should get from this guide, it is that you need to keep an eye out for every single step in this overall process. Parameters change at all times, and your ability to keep an eye on them will help ensure that you end up with an adequate result
To that end, always make sure that the tools you select allow you to monitor and control the key drying parameters – temperature, humidity, etc.
- Uniform Drying and Air Circulation: See to it that your drying equipment offers consistency and uniformity in drying across every capsule in the tray. This means having the right air circulation mechanisms – such as blowers or fans – as you begin tray softgel drying.
- Energy Efficiency: As always, look out for the equipment’s energy consumption levels. Features like insulation, heat recovery, and energy-saving modes will help cut your energy consumption – and, by extension, the overall operating costs.
- Equipment Cleaning and Maintenance: To make for a more reliable process, ensure that your equipment can easily be cleaned or dried. These tools help to cut down on downtime and are also more hygienic – an important consideration for drug manufacturing.
- Equipment Validation and Compliance: Any equipment you use should clear industry standards and regulatory requirements. Most importantly, look out for products that are compliant with Good Manufacturing Practices (GMP) and other important quality standards.
- Cost and Return on Investment (ROI): Like every other process that is implemented when pharmaceutical companies try to make pills, this one also requires a considerable financial input. However, examine the cost of each equipment as well as its comparison in relation to features, performance, and benefits
- Supplier Reputation and Support: Per usual, it is important to ensure that the equipment supplier is reputable. With Sainty Tec, you have the perfect provider of softgel drying equipment.
What To Consider As You Embark On Softgel Drying
As you begin the softgel drying process, you want to make sure that everything is as optimized as possible. That includes keeping an eye on some factors that could impact the efficiency of moisture removal and the overall success of your endeavor:
- Formulation Composition: You want to keep an eye on the composition of the fill material inside the softgel capsules.different formulations will come with different viscosities, heat sensitivities, and more, all of which will affect the rate of moisture evaporation and the drying time.
- Capsule Size and Shape: The physical form of the capsule – which includes its shape and size at the point when it goes through this process – can also influence the overall success of your endeavor. Larger capsules will most likely require more time to dry, while their shape will affect the air circulation within the drying chamber and influence uniformity.
- Moisture Content: Considering that the entire point of this process is to cut down on material content in itself, being aware of how much moisture was in the capsule to begin with will be important. If a capsule has a higher moisture content, then you’d need more time and energy for it to dry.
- Drying Parameters: Each of the drying parameters – from airflow to humidity and temperature – will also have an impact on the drying efficiency. Incorrect settings will result in a suboptimal process, so it is important to have the right parameters based on the formulation characteristics.
- Equipment Design and Performance: The design and performance of each drying equipment will also play a prominent role in determining the efficiency of the drying process. With properly designed equipment, you will be able to achieve uniform airflow, a consistent distribution of heat, and effective moisture expulsion.
- Environmental Conditions: The conditions surroundings the drying area can also affect the process. Ambient temperature, humidity, and more will need to be controlled to maintain process consistency.
- Batch Size and Loading Density: You want to make sure that you’re not overloading your drying equipment. This can impede moisture evaporation and prolong the drying process.
- Validation and Monitoring: Frequent monitoring and validation will be important to ensure quality and consistency in the overall drying process. Keep an eye on the process and ensure compliance with standards from start to finish, so you can address any issues as they come up.
By managing and considering these factors properly, you will be able to optimize your softgel mining process and ensure efficiency in moisture removal.
Implementing Proper Quality Control and Testing
We’ve spoken at length about quality control when it comes to softgel drying. And, it’s easy to see why – the process is important and can vary on a lot of factors. So, to ensure that things go off without a hitch, you want to make sure that you have the right quality control processes in place.
While the general steps can vary based on what you’re trying to achieve, some of the quality control procedures you want to keep in mind include the following:
- Visual Inspection: At frequent intervals, perform visual inspections of your dried softgel capsules to ensure that there are no defects or abnormalities present. If you do find any, address them.
- Moisture Content Analysis: If you’re interested, then you can check out some prominent testing kits for moisture content. Incorporating these will help you to find whether the dried softgel capsules are still in compliance with industry standards even after they have gone through the arduous process laid out above.
- Fill Weight Testing: With fill weight testing, you will be able to ensure that the dried softgel capsules contain the adequate amount of the fill material.
- Content Uniformity Testing: You will need to test the capsules to ensure that the active components and ingredients within the fill material are properly distributed throughout each capsule in a batch. This is especially important if your formulation comes with different active ingredients or if you need precise dosage consistency.
- Dissolution Testing: Another critical check, this one helps ensure that you can keep tabs on whether your capsules are losing some of their most critical active ingredients. It ensures that the dried capsules are able to properly release active ingredients, thus ensuring maximum bioavailability.
- Stability Testing: Get a sample of the dried softgel capsules and perform stability testing to assess their shelf life. Essentially, you will be subjecting these samples to different environmental conditions over a period of time to monitor changes in efficacy and properties.
- Documentation and Record-Keeping: All through your tests, you want to maintain accurate and exhaustive documents and records of the drying process. This ensures traceability and can facilitate top-notch quality assurance.
Potential Hiccups & Maintaining Best Practices
As you can imagine, anything as integral as this will not be as straight-cut as you think. A lot of parameters need to be in place to ensure efficiency, and you generally don’t want to end up with a substandard product at the end of the day.
With that in mind, you need to be familiar with some of the major challenges that you could encounter, as well as how best to address them:
One of the most common issues you can encounter is non-uniformity in moisture removal. With factors like capsule size and material viscosity affecting this, being able to ensure that the moisture removal is consistent is very critical.
You can address this by ensuring consistency and uniformity in the drying process across the capsule batch.
Over-Drying or Under-Drying:
You also want to achieve a proper balance between the drying parameters to ensure that you don’t go overboard with the drying process or end up not doing enough. This is one of the many reasons why proper monitoring of the drying parameters is key.
Heat Sensitivity of Formulations:
Keep in mind that some softgel formulations can be challenging while drying. This is especially true of formulations that contain volatile or heat-sensitive ingredients. High temperatures can cause degradation of potency, which will affect your overall output.
You might want to implement special considerations – such as using lower temperatures – to address some of these potential issues.
Shell Integrity Issues:
Your drying process can sometimes impede the integrity of the shell, leading to issues such as wrinkling and leakage. This is why we recommend maintaining optimal drying parameters and monitoring them to ensure that these issues can be minimized.
Drying Time and Production Efficiency:
Make no mistake about it – if you choose to go with this process, then you should be ready to make the necessary time investment to see it through. And, when you have to deal with large batch sizes or formulations, you know you might run into a challenge.
We recommend finding a way to balance production efficiency and drying time, as well as optimizing drying parameters. You should also consider the capacity of your equipment so as not to overload your tools.
By staying cognizant of all these potential pitfalls, you will find that ensuring the efficiency of your process will be more of a cakewalk. You will be able to pre-empt any possible issues, while also ensuring that your soft gelatin capsule drying process runs as smoothly as you can imagine.
Softgel drying is important for any pharmaceutical process. With these softgel capsules themselves being especially popular for making drugs and the drying process being one of the steps needed to ensure that the drugs are of the highest quality, maintaining efficiency in the entire workflow is key.
Whether you need to get your hands on softgel drying machines or you need counsel on which drying technique to follow, rest assured that we at Sainty Tec are here for you. All you have to do is let us know what you need, and we’ll be there to help you out!