| Gelating and medicine preparation |
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.
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| Gelatin Mass Supply System |
The gelatin mass should be kept at 65°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.
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Encapsulation
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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 20°C 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.
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| Tumble Drying |
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. |
| Supplemental Drying (Curing) |
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. |
| 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. |
| Polishing (for printing) |
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. |
| Packaging |
Packaging normally includes placing softgels into bulk containers, bottles
or blister packaging. |