Keep These in Mind During Production to Keep Your Softgels in Top Condition
During the softgel encapsulation process, the products will undergo multiple drying phases. As they dry and assume their final shapes, there are a few important risks to be mindful of. These can impact the usefulness or salability of the product and result in wasted product if not managed carefully.
Today, we’re going to cover some of these key risk factors to be mindful of when manufacturing softgels. With the right quality control measures in place, you stand a much greater chance of consistently producing high-quality softgels.
A Quick Overview of the Softgel Encapsulation Process
A finished softgel product contains two primary components: The outer shell and the liquid fill. The shell is most often made out of gelatin, or tapioca starch that is fed through a pair of rotating dies.
The dies cut the ribbons and join them to create a seal. While the dies cut and seal the ribbons, a pump injects fill material in between the ribbons to create the final shape.
After being cut, formed and sealed, the softgels are stripped from the ribbons and fed into tumble dryers. The softgels are tumbled through blown air to reduce the moisture content in the shell material. This sets their shape before being placed on trays to dry for an additional 24 – 48 hours.
At surface-level, this process appears rather simple and straightforward. You create, fill, seal, and then dry the shell before placing it in its packaging. However, during the filling and drying process, there are some potential risks that could impact the final product’s quality.
Common Mistakes During the Drying Process
At your pharmaceutical manufacturing facility, your quality control team should keep a close eye on these aspects of the softgel drying process. Each of these factors could potentially result in a wasted batch if not managed properly.
Incorrect Temperatures
Softgel encapsulation should take place in an environment with a temperature between 70 and 75 degrees Fahrenheit. This also applies to the drying tunnels where softgels are dried.
Lack of Adequate Humidity Control
Manufacturers should strive to achieve a relative humidity between 30 and 35 percent in the softgel drying areas. In a drying tunnel itself, the RH can be as low as 20.
Though refrigeration can be used to eliminate humidity, a dry or liquid desiccant dehumidifier often proves most effective.
When softgels are exposed to high humidity, multiple risks present themselves. They can include:
- Microbial growth and contamination
- Formula destabilization
- Unintentional chemical reactions
- General product degradation
Depending on the softgel product you are manufacturing, humidity damage could even result in product toxicity. This can put your team and your customers both at risk. Manufacturing softgels in an environment with proper humidity control can help offset these threats to product integrity and ensure consistent high-quality batches.
Improper Moisture Levels
Moisture-related risks can exist in the manufacturing environment as well as within the product itself. If shell moisture content is too high or too low in a softgel, this can create further undesirable outcomes like:
- Product clumping
- Product degradation
- Product breakage
The most common issue is too much moisture in the shell, which makes softgels less resistant to heat. During shipping (especially in the summer), softgels can spend prolonged periods of time at elevated temperatures. Customers may receive their bottle only to find a single mass of softgels that have melted together, or have leaked out all of the fill material.
Shell moisture content can be quickly and accurately assessed with a product like our Instant Softgel Moisture Analyzer. It’s quick and non-destructive test method can accurately check moisture content in 5 seconds.
Get the Right Softgel Encapsulation Equipment for Your Operations
At CapPlus, we are committed to connecting pharmaceutical manufacturers with the best production equipment for their specific needs. If you are looking to add softgel encapsulation to your suite of services or you want to upgrade your existing equipment, you can view our products here. Have a question? Contact us anytime to speak with someone from our team.