Unit Operations in

Secondary
Manufacturing
BELANISO
B E LO N G U E L
D O R OY

Compaction
Compaction to convert loose or incoherent mass of powder into one solid
object

Tablet Press
- Powder is filled to a specified depth in a die and compressed between two
punches. The compression force is ended by removal of the upper punch, and
the lower punch then moves upward in the die to eject the tablet.

Tablet Press
Single Punch Press

Tablet Press
Rotary Machine Press - the punch and dies are positioned on a rotating turret,
and output depends on the number of stations positioned around the turret
and the speed of rotation.

Direct Compression and

Granulation
Direct Compression - the process where powder blends of the drug substance
and excipients are compressed on a tablet machine. Its principle is based on
compaction
Granulation the most widely used technique to prepare powders for
compaction. A generic term for particle enlargement, whereby powders are
formed into permanent aggregates. The purpose of granulating tablet
formulations is to improve the flow and compaction properties prior to
compression. The purpose of granulating is to transform the powdered
starting materials, which would otherwise be unsuitable for tabletting, into a
form that will run smoothly on a tablet machine.

Granulation
Wet Granulation most commonly used granulation process in the pharmaceutical industry. a liquid is
added to aid agglomeration and then removed by drying prior to compression. The aim of granulation
is to increase the particle size of a powder mix, and this is achieved in wet granulation by the
formation of liquid bridges between the powder particles.
Dry mixing: The starting materials are mixed together. Prior to mixing, the ingredients may be deagglomerated
by a milling or sieving process. If the granulate has a low drug content, the active substance may be premixed
with one of the ingredients prior to being added to the granulation vessel to ensure good content uniformity.
Addition of granulating liquid: The granulating fluid is added to the dry ingredients and mixed to form a wet
mass. The mixing of the fluid with the dry ingredients leads to agglomeration of the powder. This agglomeration
can be controlled by altering the amount of fluid added, the intensity of the mixing, and the duration of the
mixing. Depending on the state of agglomeration achieved, this stage may be followed by a wet sieving process
to break up the larger agglomerates.
Drying: The fluid is removed by a drying process.
Milling: The dried granulate undergoes a sieving or milling operation to obtain the desired particle size
distribution.

Granulation

Coating
Purposes of Coating:
Protecting the drug from the environment (moisture, air, light) for stability reasons
Taste masking
Minimizing patient/operator contact with drug substance, particularly for skin
sensitizers
Improving product identity and appearance
Improving ease of swallowing
Improving mechanical resistance; reducing abrasion and attrition during handling
Modifying release properties

Coating

Packaging