The first step in softgel production begins by blending powdered gelatin and other ingredients with warm water. After hydration takes place the powder becomes a thick "syrup" called a gelatin mass. The key to mixing gelatin is to heat, blend and de-aerate as quickly as possible, this all takes place in a reactor or gelatin melting tank. The gelatin mass is then drained from the reactor through filters into portable heated stainless steel service tanks which can be rolled next to the encapsulation machine. If color is to be added, the service tank can be rolled over to a high-speed vacuum mixer prior to encapsulation.
What is the next step in Softgel Production?
The gelatin mass should be kept at 65º C while it is fed from the service tank to the encapsulation machine spreader box. Different feeding systems can be used: gravity feed from ceiling or upper level floor. In the S3 system we recommend pressurizing the service tank directly at the machine with compressed air.
Explain the Encapsulation Process?
Spreader Boxes - The gelatin mass is applied to both sides of the machine simultaneously by a set of spreader boxes which regulates the gelatin thickness from0.6 to 0.7mm as it is spread on the cooling drum. Prior to forming, the gelatin must be cooled. This is done while the thin layer of gelatin rotates with the cooling drum. Inside the machine there is a two-step process: First, the bottom side of the gelatin is cooled to 20ºC with a chilled water circulation system inside the drum. This not only assists with cooling the gelatin from the bottom side but also prevents the gelatin from sticking to the drum. Second, the topside of the gelatin is cooled with blowers.
Lubrication System - Prior to encapsulation the ribbon must be coated with a thin layer of oil to prevent sticking during the filling and sealing process. The application of this oil is critical because over lubrication requires more drying time and polishing time. The S3 has a unique lubrication system that greatly reduces the amount of oil required by using a micro fine filter system. Most others use what is known as an oil bath where the ribbon is 100% submerged into a container of oil. Commonly used lubricants are: digestible mineral oil, Fractionated Coconut Oil and Miglyol 812.
Medicine Filling Pump - Before the capsule can be formed and sealed, it must be filled with material. The material to be filled flows by gravity into a positive displacement pump which meters the correct amount of material through the wedge and into the gelatin ribbon between the dies.Individual plungers pull a precise amount of material from the hopper and deliver it to the injection wedge. Weight variation can be controlled within +/- 0.05ml.
Capsule Forming & Filling - After the two halves of gelatin have been cooled and lubricated, they meet together at the forming and filling station. Dies that contain small pockets in the shape and size of the capsule to be made help form and seal. The gelatin ribbon is forced into these pockets with the fill material, which causes the shape to take place.While the capsule is being filled, it is also simultaneously being sealed and cut from the ribbon.
What does the encapsulation process look like?
Typically the softgel machine needs very little monitoring and will produce the softgels up to the tumble drying stage before intervention is needed. (4" R&D Softgel machine pictured)
What happens after encapsulation?
After the encapsulation the softgels are sent down a conveyor to the tumble dryers.
Can you explain the tumble dryer procedure?
Immediately after filling the capsules are transferred by conveyor and blower to the tumble dryers. At this point, the capsules are very soft due to the high moisture content. The tumble dryer is used to remove a thin layer of mineral oil from the surface of the capsule and to accelerate the drying process by 50%. Drying is the process of taking the moisture from the inside of the capsule to the outside. After the initial moisture is removed through the tumble dryers you have a dry surface but a wet inside, and what you try to do is get to equilibrium. The idea is to reduce the amount of moisture in the gelatin so it dries as quickly as possible to achieve proper shell moisture content of 6 to 10 percent depending on the type of formula.
Why do the Softgels need to be dried?
While the tumble dryer removes most of the moisture from the capsules, additional drying is needed. The capsules are placed on drying trays then into drying racks and into rooms where dry air is circulated around them for a period of up to 48 hours.
What happens after the softgels are dry?
Inspection:
Capsules should be submitted to a final inspection before packing for malformed, damaged or improperly filled capsules. This can be done visually by hand on trays or tables or semi-automatically on a roller inspection machine.
What if I want to print on the Softgel Capsules?
If there is a desire to print on the exterior of the capsule, all remaining mineral oil residue must be removed otherwise the printing ink will not dry properly and be removed during handling.
What happens if I produce errors in my Softgels?
While the dies are manufactured to strict tolerances, there can be a slight variation in capsule size due to air pockets in the gelatin or the fill material. To assure that all capsules are uniform in shape and size a capsule sizing machine can be used. It will eliminate over and under sizes by measuring external dimensions.
Can I reclaim my softgel liquid after it's been encapsulated?
Softgel pulverizer is used at the end of the Softgel process. This is a way to reclaim the product from misfed or rejected capsules.
Packaging?
Packaging normally includes placing softgels into bulk containers, bottles or blister packaging. (See our Blister machines or Packaging machines for more information)