One day training report on

By
Gopika S Pillai
S2 FT & QA
COMPANY PROFILE

 Sangrose laboratories was incorporated in 1987

 Mastermind behind this was Mr C K Alexander

 Started production of anti leprosy bulk drug Clofazimine

 Done under the standards of INDIAN

PHARMACOPOEIA
 SECTIONS VISITED
 Tablet manufacturing and packaging

 Soft capsule manufacturing and packaging

 Oral liquid manufacturing and packaging

 Ointments and cream manufacturing and packaging

 Quality control laboratory

 n d
r i n gA
fa c t u
a n u g
g M a g i n
D r u Pa c k
TABLET MANUFACTURING AND PACKAGING

The machines needed for the manufacturing and packaging

It is an electronic device
used for the weighing of
large scale raw materials
and final products in the
manufacturing.
MIXING EQUIPMENT

The planetary mixer is an

industrial equipment
conceived/made to prepare
food, drug, chemical, ceramic
dough or other type of product,
replacing manual labour
through a mechanical system
that allows to produce,
continuously, large quantities of
dough.
GRANULATING EQUIPMENT

Mass mixing Granulator is

a multi-purpose processer
equally suitable for high
speed dispersion of dry
powders, aqueous or
solvent granulation, and
effervescent products and
melt pelletization.
 Oscillating granulator (mill integrated
with roller compactor). The principle of
an oscillating granulator is to
mechanically pass compacted material
through a wire mesh screen or plate using
an oscillating rotor. The rotor speed and
rotation time are variable in the clockwise
or counter clockwise directions. Particle
size is controlled through mill-screen size,
rotor speed, and the rotor's rotation angle
MILLING

It is a self contained portable unit

useful for granulating, pulverizing,
mixing and size reduction. The Multi
mill operates on the principle of
variable force swing beaters having
both knife and impact edges rotating
within a selected screen to get the
required size reduction.
DRYING EQUIPMENT

A fluid bed dryer is a kind of equipment which

can be used for applications like drying of
powders, mixing of powders and
agglomeration. This is efficiently employed for
applications in chemical, pharmaceutical, dye
tuff, foodstuff, dairy and various other process
industries. Fluid bed dryers are often employed
with the spray dryers and granulation systems
for effective drying, mixing, granulation ,
finishing and cooling of powdered substances
DOUBLE CONE BLENDER

The double cone blender is used to

produce homogeneous solid-solid
mixture. Mixing is a common process
step in the manufacture of products for
industries such as healthcare,
food, chemical, cosmetics, detergents,
fertilizers and plastics.
TABLET COMPRESSION MACHINE

Tablets are being formed by

compressing the granules by using
the compression machine. Tablet
formed in compression machine by
pressing the granules in die with
lower and upper punch. Tablet
formation takes place by the
combined pressing action of two
punches (lower and upper) and a die.
 The tablet cores to be film
coated make continuous
complicated orbital motion
within the closed rotating
drum under the action of a
streamline guide plate.
During the motion, coating
medium automatically sprays
according to the technological
process and rational
technological parameters, at
the same time hot air is
supplied under a negative
pressure.
PACKAGING MACHINE

Blister pack are created by means

of a form – fill – seal process at the
pharmaceutical company or
designed contract packer. A form –
fill – seal process means that the
blister pack is created from rolls of
flat sheet or film, filled with the
pharmaceutical product and closed
on the same equipment.
 The strip packing machine is
used for the quality packing of
various tablets in
pharmaceutical industries.
SOFT CAPSULE MANUFACTURING AND
PACKAGING

ENCAPSULATION
MACHINE
Encapsulation

The encapsulation process begins when molten gel is

pumped to the machine and too thin ribbons of gelatin are formed.
These ribbons then pass over a serious of rollers and are continuously
fed between two rotatory die cylinders that determine the size and
shape of the capsule, which form two half of a capsule. the ribbons
converge next to a fill injector , where the appropriate volume of fill
material to be encapsulated is measured and dispensed by a pump. As
the die assembly rotates, the filled capsule halves and pressure and are
then injected . since soft gel manufacturing involves high precision ,
this process permits accurate and reproducible fill uniformity. During
the rotary die process , the gelatin temperature, ribbon thickness,
seam width and fill quantity all need to be monitored and controlled.
Gelatin preparation
The gelatin powder is
mixed with water and glycerine ,
then is heated and stirred under
vacuum. Any required colors or
flavours are added to the gelatin
mix and then kept in a steam-
jacketed , stainless steel vessel at a
constant temperature.

DIFFERENT SHAPES OF CAPSULE

ORAL LIQUID MANUFACTURING
ANG PACKAGING

Oral liquids are homogeneous

liquid preparation usually contains a
solution , an emulsion and a suspension
and one or more active ingredients in a
suitable base. They may also contain
sweetening agents, flavouring agents and
permitted coloring agents.
SYRUP FILLING AND PACKAGING
MACHINE
OINMENTS AND CREAM MANUFACTURING AND
PACKAGING

OINMENT MANUFACTURING AND

PACKAGING MACHINE
QUALITY CONTROL LABORATORY

The quality is assured mainly in three

stages
Raw material analysis
In process analysis
Finished product analysis
 CHEMICAL AND PHYSICAL ANALYSIS

The
main physical and chemical analysis are the
following
 ACID VALUE
 PEROXIDE VALUE
 IODINE VALUE
 DENSITY
 SPECIFIC GRAVITY
 REFRACTIVE INDEX
 SOLUBILITY
 SPECIFIC OPTICAL ROTATION
 LOSS ON DRAIN
it is used to find out the organic impurities
in the solid substance
 SULPHATED ASH
 pH
 ABSORBANCE OF COLOUR
 DISINTEGRATION

DISINTEGRATION MACHINE
 Disintegration time is the time
required for a dosage form to break up in to granules
of specified size (or smaller) under carefully specified
conditions.
Different medicine type have
different DT that is capsule have a DT of 60 min,
Coated tablet have a DT of 30 min and Uncoated
tablet have DT of 15 min

 FRIABILITY
Friability is the tendency for a tablet to chip, crumble

or break following compression. This tendency is

normally confined to uncoated tablets and surfaces
during handling or subsequent storage.
It can be caused by a number of
factors including poor tablet design (too sharp
edges), low moisture content, insufficient binder,
FRIABILITY TEST MACHINE
MICROBIOLOGICAL ANALYSIS

The microbiological analysis is also

performed under the guide lines of Indian
pharmacopeia to ensure the microbiological safety
of the product on the storage period and exporting
time.
As any other industry they also do
pour plate culturing and serial dilution for the
microbiological analysis.
 S O F
D UC T
P R O
M AI N S E
TH E G R O
SA N
ALWAYS REMEMBER ONE
THING

“ DRUGS AREN’T COOL ,

THEY MAKE YOU LOOK LIKE A
FOOL ”

NK
H A
T