1. Peter Samir, Aya Mohamed, Passainte chohayeb, Fatma Ismail, Abdelrahman Nag, Nada Hamdy, Sarah Hassan, Omar Badr, Amr Sherif, Omar Elsorady, Hesham Abdelaziz
Hard and soft Capsules Production line
References
• http://www.kwangdah.com/kde-300.htm
http://drtedwilliams.net/kb/index.php?pagename=Soft%20Capsule%20Recipr
ocating%20Die%20Process
• .http://formulation.vinensia.com/2011/06/manufacturing-process-of-soft-
gelatin_14.html
• http://chinashengh.en.alibaba.com/product/1417329635220468543/HSR_250
_soft_gelatin_encapsulation_production_machine.html
Gelatine Preparation
Raw granular gelatin is mixed with glycerin and water.
Coloring agent can also be added at this stage. Glycerin
acts as a plasticizer in the gelatin compound. Other
plasticizers can also be used either alone or in
combination with glycerin, such as sorbitol.
After the ingredients are combined, the mixture is placed
into a reactor called as gelatin melter.
Machine : Gelatin melting tank
This process takes around 3 hours until the gelatin turns
into a molten liquid mass. As soon as the liquid gelatin
mass is ready for encapsulation process, it is transferred
to ground heated tanks which are wheeled into the clean
room where the main encapsulation machine is.
Machine : Heated tank
Abstract
Capsules are one of the solid dosage forms,
administered by oral route. Capsules are classified into
hard gelatin and soft gelatin capsules, according to the
amount of plasticizer in the formula. In this poster, our
scope is the production line of soft gelatin capsules and
hard capsules.
The production line of the soft and the hard capsules
share one or many steps of production for example the
first step which is concerning with producing the gelatin
itself fro which the shell is formulated.
Briefly, soft gelatin capsules production line consists of
three steps: Gelatin preparation, Encapsulation and
Drying.
Soft gelatin capsules (soft elastic gelatin capsules) or
(soft gels) are prepared from continuous gelatin shells to
which glycerin or a polyhydric alcohols such as sorbitol
has been added to render gelatin elastic or plastic-like.
On the other hand Hard gelatin capsules production line
consists of four steps : Gelatin preparation, Selection of
the capsule size. Filing the capsule shells, Polishing and
sealing.
.
I. Soft Gelatine Capsule
First Step (Encapsulation)
Encapsulation is the manufacturing process that brings the
gelatin shell and the fill material together to form Softgel
capsules. It takes place in a closed environment called
clean room where the relative humidity is around 20%.
Encapsulation can be done by 3 processes:
1) Plate process:
which depends on placing a gelatin sheet over a die plate
containing numerous die pockets, with the application of
vacuum to draw the sheet into the die pockets. After that the
pockets are filled with liquid or paste, they are covered by
another gelatin sheet.
2) Rotary die process:
Liquid gelatin is formed into two ribbons which are
continuously brought together between twin rotating dies. At
the moment that the dies form pockets of the gelatin ribbons,
metered-fill material is injected between the ribbons. Then the
pockets of fill-containing gelatin are sealed by mechanical
pressure and by heating the ribbons by the wedge at 37-40C.
The capsules are subsequently severed from the ribbon. As
the capsules are cut from the ribbons, they may be collected
in a refrigerated tank to prevent capsules from adhering to one
another and from getting dull.
KDE-300 Automatic
Soft Gelatin Encapsulation
3) Accogel /stern machine:
Uses a system of rotary dies but is unique in that it is the only
machine that can successfully fill dry powder into a soft gelatin
capsule. The process involves a measuring roll that holds the
fill formulation in its cavities under the vacuum and rotates
directly above the elasticized sheet of the gelatin ribbon. The
ribbon was drawn into the capsule cavities of the capsule die
roll by vacuum. The measuring rolls empty the fill material into
the capsule-shaped gelatin cavities on the die roll. The die roll
then converges with the rotating sealing roll covered with
another sheet of elasticized gelatin. The convergence of two
rotary rolls creates pressure to seal and cut the formed
capsules.
I. Soft Gelatine Capsule(Cont.)
Second Step (Drying)
Drying process purpose is to decrease the moister
content to create a hard and durable finished soft gel
capsules ready for packaging. After the soft gels are
formed, they contain around 20 percent water. This
amount of water content is needed to keep the gel flexible
enough to form the capsules.
Drying process requires an environment with low relative
humidity in the air but not hot air. This process divided
into two stages:
1. First stage : performed by a tumble dryer consists of
sections. This equipment tumbles the soft gels around
30 to 40 minutes and removes approximately 25
percent of the water content in the soft gel capsules.
2. Second stage : soft gel capsules are spread on
stackable trays and transferred to the drying room or
tunnel where high air flow exists and they stay around
24 to 48 hours or until the soft gels become hard
enough. This process is called natural manual drying.
By using a fully automatic Soft gel drying machine,
this long drying process time can be reduced to a few
hours which enables you to save time and money.
Fluid Bed Tumble Drier Soft Capsule Drying
II. Hard Gelatin Capsules
1-Manufacturing of the empty capsules shells
1- Dipping :Pairs of the stainless steel pins are dipped
into the dipping solution to simultaneously form the caps
and bodies. The dipping solution is maintained at a
temperature of about 50 0 C in a heated, jacketed dipping
pan.
2- Spinning :The pins are rotated to distribute the gelatin
over the pins uniformly and to avoid the formation of a
bead at the capsule ends.
3- Drying :
The gelatin is dried by a blast of cool air to form a hard
shells. The pins are moved through a series of air drying
kilns to remove water
4- Stripping :A series of bronze jaws strip the cap and
body portions of the capsules from the pins
5- Trimming and Joining: The stripped cap and body
portions are trimmed to the required length by stationary
knives. After trimming to the right length, the cap and
body portion are joined and ejected from the machine.
II. Hard Gelatin Capsules(Cont.)
2- Selection of Capsules Size The selection of capsule
size is best done during the development of the
formulation, because the amount of inert materials to be
employed is dependent upon the size or capacity of the
capsule to be selected. The density and compressibility of
a powder or a powder mixture will largely determine to
what extent it can be packed into a capsule shell. The
amount may vary according to the degree of pressure
used in filling the capsules.
To determine the size of capsule to be used or the fill
weight for a formulation the following relationship is used:
Capsule fill weight =Tapped Bulk Density of Formulation X Capsule Volume
3- Filling the capsule shells
1- "Punch" Method
2- Hand-Operated Capsule Filling Machines
3- Semi-Automatic Operated Capsules Filling Machines
4- Automatic-Operated Capsule Filling Machines
Machines used
Feton capsule filling
Semi-Automatic Capsule Filling Machine (JTJ-A)
Osaka capsule filling machine(Automatic Operated Filling)