PHARMAPLUS PHARMACEUTICS

MANUFACTURING PROCESS

The soft gelatin capsules are manufactured under high precision and stringent quality controls by
following methods:

1. GLOBEX METHOD
2. ROTARY DIE PROCESS
3. ACCOGEL MACHINE
4. PLATE PROCESS
5. RECIPROCATING DIE

Every major process in the production of soft gelatin capsules is carefully controlled,
standardized and highly sophisticated.

COMPOSITION OF SOFT GELATIN CAPSULE (SGC)

 GELATIN: Ideal substance for capsulation (USP grade). Bloom strength: 150-250 gm, viscosity:
2.5-4.5 cp and iron content not greater than 15 ppm.
 PLASTICIZER: Glycerin USP, Sorbitol USP, and their combination.
 PRESERVATIVE: Methylparaben: Propylparaben (4:1), sorbic acid (0.2%)
 COLORANTS: FD & C water-soluble dyes, certified lakes, pigments.
 OPACIFIER: Titanium dioxide.
 FLAVORING AGENT: Ethyl vanillin, Essential oils.
 Fumaric acid: To aid solubility and to reduce aldehyde tanning of gelatin.

STEPS OF MFG. OF SGC

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PHARMAPLUS PHARMACEUTICS

ENCAPSULATION PROCESS

GLOBEX METHOD:
 The lipophilic fill & the shell formulation
are stored in separate containers, both
kept warm.
 These materials are pumped through a
concentric double capillary with fill in
the inner one.
 The capsule formation depends upon the
interfacial tension between fill & shell
material.
 In attempt to reduce the surface tension, a
droplet is formed and hence seamless
round soft capsules are formed.
 The end of the double capillary is
immersed in a cooling bath containing
liquid paraffin at about 4°C.
 Capacity: 10,000-40,000 capsules/hr.

ROTARY DIE PROCESS:

At the same time when two film sheets are heat-

sealed, the content liquid is filled, where the film
sheets are dilated and formed by injection pressure.

The molten gel is pumped to the machine and two thin
ribbons of gel are formed, one on either side of the
machine.

These ribbons then pass over a series of rollers and
over a set of dies that determine the size and shape of
the capsules.

The fill is fed from its container to a positive
displacement pump, which accurately doses the fill
and injects it between the two gelatin ribbons prior to
them sealing together through the application of heat
and pressure.

The resultant capsule is incredibly flexible due to the water added to the gel mass.

Capsules produced can have all kind of shape, sizes, and can be made with different colors for each
half.

Not governed by surface tension phenomena, so wider variety of fills can be encapsulated than
with Globex method.

Capacity: Upto 1,00,000 capsules/hr.

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