SEMINAR ON

Preparation of Qualitative and

Quantitative Departmental layout
with Equipments Required for
Solids dosage form

PREPARED BY
MATHOLIYA CHETAN
1ST SEM. M.PHARM

LIST OF THE FORMLATION OF DOSAGE

FORM

FOR SOLID
TABLETS
CAPSULES

TABLET
3

INTRODUCTION
DEFINITION:These are solid dosage forms each containing a
unit dose of one or more medicaments.

ADVANTAGES: Unit dosage form with greatest dose precision &

least content variability among all oral dosage
forms .
Cost is lowest among all oral dosage forms.
Lightest & most compact of all oral dosage forms.
Easiest & cheapest to pack & ship among all oral
dosage form.
Tamperproof.

 May

provide greatest ease of swallowing with

least tendency for hang up above the stomach.
Better suited for large scale production

DISADVANTAGES:
Drug having amorphous nature & low density
drug can not compressed into tablets.
Drugs with poor wetting properties cant be
formulated to make as tablet.
Bitter tasting drugs, drugs with an objectionable
odor, drug sensitive to oxygen coating may be
required.

QUALITATIVE LAYOUT WITH CIRCULAR FLOW

CIRCULAR LAYOUT
Materials

are weighed into batch quantities

in dispensing & then moved into the
manufacturing area. After completion of
manufacturing the finished tablets are
placed in quarantine & moved to bulk
stock upon release .when packaging run is
scheduled tablets, packaging components,
are delivered from the bulk stock &
approved storage area.

LAYOUT WITH CROSS OVER TRAFFIC

LAYOUT WITH PARALLEL FLOW

ENVIRONMENTAL REQUIREMENT:
NAME OF AREA

PRESSURE
MAINTAINED

WARE HOUSE

10 PASCAL

WEIGHING AREA

20 PASCAL

TABLETTING AREA

15 PASCALS

CENTRAL CORRIDOR

30 PASCALS

Temperature 2550C
Humidity 55 10 % RH
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 Humidity

should be lowered for specific products

like Effervescent tablets & moisture sensitive
drugs.
Pressure within areas like mixing & tabletting
area should remain on negative side than central
corridor
Temp control & Air control should be such that
there
should
be
comfortable
working
environment. & no impact on characteristics of in
process materials such as granulations, raw
materials.
All areas should be properly ventilated with the
use of roof fan.

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EXAMPLE: Suppose

a batch of 1,00,000 tablet is to be

prepared then each tab weighing 600mg then
total powder material to be taken will be 60kg.

Equipments

used will be of following capacity:

Planetary mixer 100kg
Fluidised bed dryer 60kg
For final mixing octagonal mixer 500kg.
Compression machine 42 produces 1 lakh
tablet in 1 hour..
Coating 16 inch pan size can coat 50,000 tabs
at a time
Packing-strip & blister(single track) can pack
3 lac tab. Per day

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GRANULATION:
Wet

Granulation
Direct Compression
Dry Granulation
OR Slugging
OR Roll Compaction

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GRANULATION STAGES ( fl ow sheet

of granulation)

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Direct Compression:

Direct compression is Compressing tablet directly

from powdered material without modifying the
physical nature of the material. It was reserved for
small group of crystalline chemicals having
physical properties for the formulation of a good
tablet.

Dry Granulation (slugging) :-

Dry

granulation is used when

Effective dose of drug is too high for direct
compression
Drug is sensitive to heat or moisture or both.
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ROLLER COMPACTOR

The capacity of the machine is upto 200

kg.

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WET GRANULATION: In

this method the powder constituents are

converted to a moist cohering mass by the
incorporation of granulating fluid. Granules
formed by passing the moist mass through a
screen and dried, rescreened to breakdown
agglomerates and blended with other tablet
additives such as lubricants and disintegrate
and then compressed to tablets.

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Classification of Equipments for wet granulation:-

A) High shear mixer / granulator:- includes

Littleford lodige mixer
Littleford MGT Granulator
Gral mixer /Granulator
Diosna mixer / Granulator

B)

Granulator with Dryer :- Includes

Fludised bed Granulator
Day Nauta Mixer Processor
Double Core/ Twin Shell Granulator
Topo Granulator
C)

Specialized Granulators :- Includes

Roto Granulato
Marumerizer

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DRYING OPERATIONS:Fluidised bed dryer :-

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 Principle

: When a gas is allowed to flow through a bed of

particulate solids at a velocity greater than the settling
velocity of the particles.& less than the velocity for
pneumatic conveyor, the solids are buoyed up &
become partially suspended in the gas stream. the
resultant mixer of solids & gas behaves like a liquid &
solids are said to be fluidized.
Dryer capacities range from 5kg to 200kg.average
drying time is about 20-40 min.
Advantages: 2-6

fold advantage in thermal efficiency over tray dryer.

Faster in both drying & handling time than the tray
dryer.
Higher drying temp can be applied than tray & truck..
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COMPRESSION MACHINE:
Tablet

machine is regulated by..

Number of tooling sets
Number of compression station
Rotational speed of the press
Different stages of compression:

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HAND OPERATED
TABLET MACHINE

ROTATORY TABLET
MACHINE

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COATERS:GENERAL TYPES OF COATING

EQUIPMENT
(1) Standardized coating pan

Loading capacity of the pan is upto 275 kilogram.

Motor with horse power of range 0.5 to 5 is available of spraying.
This coater is available with S.S. 304 and 316.
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FLUIDIZED BED COATER:-

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 This

coater is available with SS 304 AND SS 316

quality.
Pharmaceutical granules with 20-25% moisture
can be dried in 30-45 mins.
Load about 300 Kg can be placed.
Motor of horse power 1.5 to 25 is used.
Length is about 650-2250 mm. width is about
750-1900 mm and height of the equipment is
about 1550-3550 mm.

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CAPSUL
E
26

INTRODUCTION
Capsules

are gelatin shells filled with the

ingredients that make up an individual dose.
Dry powders, semi-solids, and liquids that do
not dissolve in gelatin may be encapsulated.

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TYPES OF GELATIN CAPSULE

1. Hard Gelatin
Capsule

2. Soft Gelatin
Capsule

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HARD GELATIN CAPSULE SIZES AND

THEIR APPROXIMATE CAPACITIES

PAPER
910201/HIMANSHU/M.PHARM/2
009-10

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29

PLANT LAYOUT FOR CAPSULE

MANUFACTURING DEPARTMENT

ENVIRONMENT CONDITION FOR CAPSULE FILLING AREA

Humidity:
Not more than 35% RH
30
Temperature:
Not more than 25%

STEPS OF MANUFACURING OF HARD

GELATIN CAPSULE SHELL

31

GELATIN SOLUTION

DIPPING

SETTING

32

DRYING

TO AUTOMATICS

STRIPPING
33

CUTTING

JOINING

FINISHED CAPSULE

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GELATIN SPECIFICATION FOR HARD GELATIN

CAPSULE

GELATIN PROPERTIES

PIG SKIN

FISH

240-255,

220-260

13.0

13.0

1.

1.0

PH ,1% SOLUTION

5.2-5.8

5.5-6.0

ISO IONIC POINT,PH

7.0-9.4

7.0-9.4

BLOOM(G)0
+MOISTURE (%MAX)
ASH (%MAX)

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GELATIN PROPERTIES

PIG SKIN

FISH

100

100

40

40

Absent

Absent

500

500

E.COLI IN 10 GM

Absent

Absent

P. AERUGINOSA IN 10

Absent

Absent

PARTICLE SIZE %
PASSING 4 US #
SO2 (PPM MAX)
H2O2
MICROBIAL STANDARDS

TOTAL COUNT

GM
36

FILLING OF CAPSULE
A. DIRECT FILLING METHOD

1. AUGER FILLING METHOD

2.VIBRATION ASSISTED FILLING

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B. INDIRECT FILLING METHOD

1. TAMP-FILLING METHOD

2. DOSATOR NOZZLE MACHINE

3. VACUUM-FILLING METHOD
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GENERAL REQUIREMENT
The

environment condition in which filling of hard

gelatin capsule should be normally carried out is:
Humidity:
Not more than 35% RH
Temperature:
Not more than 25 C
These conditions should be maintain even work has
stopped at the end of working day and during the
week- ends.
The area around machine should be kept clean at all
times. Spillage should be cleaned up promptly.
The machine must be thoroughly cleaned during the
week ends and when there is a product change over.
The speed gear should not be adjusted when the
machine is running on power,
Operator should wear rubber gloves, nose mask and
head covers when the machine is operated for filling.
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PLANT LAYOUT FOR SOFT GELATINE CAPSULE

40

COMPOSITION OF SOFT GELATIN CAPSULE SHELL

FORMULATION

EXAMPLE

Gelatine
Plasticizer

Glycerine
Sorbitol

Water
Preservative

Methyl paraben
Propyl paraben

Colorants

Certified lakes

Opacifier

Titanium dioxide

Flavouring agent

Ethyl vanillin

41

STEPS OF MFG.OF SOFT GELATINE CAPSULE

42

GELATIN SPECIFICATION FOR SOFT GELATINE CAPSULE

GELATIN PROPERTIES ACID OSSEIN

BLOOM(G)0

FISH

180-210

160-210

13.0

13.0

1.

1.0

PH ,1% SOLUTION

5.0-6.0

5.0-6.0

ISO IONIC POINT,PH

6.0-8.0

7.0-9.4

MOISTURE (%MAX)
ASH (%MAX)

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GELATIN PROPERTIES

ACID OSSEIN

FISH

PARTICLE SIZE % PASSING

100

100

SO2 (PPM MAX)

60

60

H2O2 (MAX)

60

60

Clear

no precipitate

500

500

E.COLI IN 10 GM

Absent

Absent

P. AERUGINOSA IN 10 GM

Absent

Absent

4 US #

CLARITY (45% solution in

30% glycerol)
MICROBIAL STANDARDS
TOTAL COUNT

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GELATIN MASS PREPARATION

The Shell of the Soft Gelatin

Capsules
comprises
of
pure
Pharmaceutical grade Gelatin, a
plasticizer (usually Glycerin), and
other ingredients.
Gelatin Shell raw Materials are
accurately weighed and then
treated with demineralized water
and melted under vacuum in large
stainless steel pressure tanks.
Completed batches are then
transferred to the production lines
in heat controlled receiving tanks
in which the gelatin mass are
maintained at the
required
temperature and viscosity.
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ENCAPSULATION PROCESS:

GLOBEX METHOD

46

 The lipophillic fill and the shell formulation are

stored in
separate containers, both kept warm.
The fill and the shell material are pumped
through a
concentric double capillary, with fill in the
inner one. The fill
is pumped in pulses to give fill volumes
between 20 to 600
mg.

Here, the formation of capsule depends upon

the
interfacial tension between the fill and shell
material.

The shell material possesses a higher surface

tension. In
attempt to reduce the surface tension, the

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 Advantages:

Seamless capsules, which are tamperevident.

Free of contamination or air entrapment.
Risk of leakage is minimal.

Capacity:
10,000-40,000 capsules per hour.

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ROTARY DIE PROCESS

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THANK U

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