A PROJECT REPORT

ON
PRODUCTION PROCESS OF A TABLET
BY
VENKATESHWAR .D (3511310152)
SARDAR SHAREEF. S (3511310161)
VIVIN SAMUEL. S (3511310162)
GOWTHAM. D (3511310172)

UNDER THE GUIDANCE OF
Dr. DEENA ROY (Asst Prof )

In the partial fulfilment of the requirements for the award of the degree of
MASTER OF BUSINESS ADMINISTRATION
SCHOOL OF MANAGEMENT
SRM UNIVERSITY

FACULTY OF MANAGEMENT
KATTANKULATHUR



PRODUCTION AND OPERATIONS MANAGEMENT
Mini Project
on
PRODUCTION PROCESS OF A TABLET



By
Venkateshwar .D (3511310152)
Sardar Shareef. S (3511310161)
Vivin Samuel. S (3511310162)
Gowtham. D (3511310172)


INTRODUCTION
Manufacturing is the production of product for use or sale using labour
and machines, tools, chemical and biological processing, or formulation. The term may refer
to a range of human activity, from handicraft to high tech, but is most commonly applied
to industrial production, in which raw materials are transformed into finished goods on a
large scale. Such finished goods may be used for manufacturing other, more complex
products, such as aircraft, household appliances or automobiles, or sold to wholesalers, who
in turn sell them to retailers, who then sell them to end users the "consumers".
A manufacturing plant has a specific type of layout. Plant layout refers to the
arrangements of physical facilities such as machines, equipment, tools, furniture etc. In such
manner so as to have a quickest flow of materials at the low cost and with least amount of
handling in processing the product from the receipt of raw materials to the delivery of the
final product.
Tableting is a method of confectionery manufacture that shares many similarities
with tablet pharmaceutical production.
OBJECTIVES OF A GOOD LAYOUT
Proper and efficient utilization of available floor space.
Transportation of work from one point to another point without any delay
Proper utilization of production capacity
Reduce material handling
Utilize labour efficiently
Reduce accidents
Provide for volume and product flexibility
Provide easy of supervision and control.
Provide for employee safety and health
Allow easy maintenance of machines and plant
Improve productivity





Typical layouts for solid dosage form manufacturing:
1. Perimeter manufacturing, centre warehouse.
2. Circular flow.
3. Straight line flow.


1. PERIMETER MANUFACTURING, CENTRE WAREHOUSE:
In this type the centre, or core, of the facility is a storage or warehouse area for raw
materials, packaging components, and bulk stocks, with the manufacturing and packaging
operations located at the outer perimeter.

Advantage: Space conservation by virtue of having the supply areas close to the areas
being supplied.

Disadvantage: Chances of contamination or mix up b/c of crossover traffic pattern of
material.



2. CIRCULAR FLOW:
It consists of receiving , approved raw materials and components storage, and
dispensing on one side, with manufacturing, quarantine, bulk stock, and packaging across a
central corridor.

Advantage: Since the flow is circular so it eliminates much of crossover traffic










3. PARALLEL LINE FLOW:
It consists of basic parallel line flow to minimize contamination or mix-up, moving the
materials along a critical path.

Advantage: Minimal crossover of materials.

Disadvantage: Additional space required to accommodate this configuration.









PRODUCTION PROCESS
The manufacture of oral solid dosage forms such as tablets is a complex multi-stage
process under which the starting materials change their physical characteristics a number of
times before the final dosage form is produced. Traditionally, tablets have been made by
granulation, a process that imparts two primary requisites to formulate: compatibility and
fluidity. Both wet granulation and dry granulation (slugging and roll compaction) are used.
Regardless of whether tablets are made by direct compression or granulation, the first step,
milling and mixing, is the same; subsequent steps differ. Numerous unit processes are
involved in making tablets, including particle size reduction and sizing, blending,
granulation, drying, compaction, and (frequently) coating. Various factors associated with
these processes can seriously affect content uniformity, bioavailability, or stability.

DISPENSING
Dispensing is the first step in any pharmaceutical manufacturing process. Dispensing
is one of the most critical steps in pharmaceutical manufacturing; as during this step, the
weight of each ingredient in the mixture is determined according to dose. Dispensing may be
done by purely manual by hand scooping from primary containers and weighing each
ingredient by hand on a weigh scale, manual weighing with material lifting assistance like
Vacuum transfer and Bag lifters, manual or assisted transfer with automated weighing on
weigh table, manual or assisted filling of loss-in weight dispensing system, automated
dispensaries with mechanical devices such as vacuum loading system and screw feed system.
Issues like weighing accuracy, dust control (laminar air flow booths, glove boxes), during
manual handling, lot control of each ingredient, material movement into and out of
dispensary should be considered during dispensing.
A centralized weighing department is recommended.
Ideally the area should be an enclosed facility adjacent to manufacturing area,
using approx. the same construction materials utilized in the manufacturing areas.
Adequate recessed lighting (125 f).
Proper humidity and temperature control.
Weighing stations should perform diversity of weighing.


The weighing rooms are approx. 10*8*7 ft.
Each room has a self contained, air handling unit and moves air from left to right
across the work area through perforated plates located on each side of room, at a
velocity of 90 to 110 feet/min.
The air should filtered through a bank of pre filters and then through HEPA filters
before return to room.
Make up air should be conditioned to maintain a temperature of 75 78F and
returned to room.
An equal amount of air is removed after HEPA filters to maintain room balance.
Weighing is performed in the deepest part of room to prevent any dust migration
Horizontal laminar flow hoods with bench top are recommended for small quantity
weighing (1 Kg).
If the operation is small, standard dial or digital readout scales may be used.
For larger operation mini computerized digital readout weighing systems are used.
Monthly schedule for calibration and inspection of scales by outside scale contractor
should be performed.
A washroom for cleaning and storing weighing utensils is also recommended.
Space should be available for storage of weighing batch quantities until they are
required in processing areas.










SIZING
The sizing (size reduction, milling, crushing, grinding, pulverization) is an important
step in the process of tablet manufacturing.
In manufacturing of compressed tablets, the mixing or blending of several solid
pharmaceutical ingredients is easier and more uniform if the ingredients are about the same
size. This provides a greater uniformity of dose. A fine particle size is essential in case of
lubricant mixing with granules for its proper function.
Advantages of smaller tablets are as follows:
Increased surface area, which may enhance an active ingredient's dissolution rate and
hence bioavailability
Improved tablet-to-tablet content uniformity due to a larger number of particles per unit
weight
Controlled particle size distribution of dry granulation or mix to promote better flow of
mixture in tablet machine
Improved flow properties of raw materials
Improved colour and/or active ingredient dispersion in tablet excipients
Uniformly sized wet granulation to promote uniform drying
The following problems may arise if the process is not controlled properly:
A possible change in polymorphic form of the active ingredient, rendering it less or
totally inactive, or unstable.
A decrease in bulk density of active compound and/or excipients, which may cause flow
problem and segregation in the mix.
An increase in surface area from size reduction may promote the adsorption of air, which
may inhibit wettability of the drug to the extent that it becomes the limiting factor in
dissolution rate.





POWDER BLENDING
The successful mixing of powder is more difficult than mixing liquid, as perfect
homogeneity is difficult to achieve. A further problem is the inherent cohesiveness and
resistance to movement between the individual particles. The process is further complicated
in many systems by the presence of substantial segregation influencing the powder mix. This
arises from the difference in size, shape, and density of the component particles. The
powder/granules blending are involved at stage of pre granulation and/or post granulation
stage of tablet manufacturing. Each process of mixing has an optimum mixing time, and
longer mixing may result in an undesired product. The optimum mixing time and mixing
speed must be evaluated. Blending prior to compression is normally achieved in a simple
tumble blender. The blender may be a fixed blender into which the powders are charged,
blended and discharged. It is now common to use a bin blender. In special cases of mixing a
lubricant, over mixing should be particularly monitored. The various blenders used include
"V" blender, Oblicone blender, Container blender, tumbling blender, Agitated powder
blender. But nowadays to optimize the manufacturing process particularly in wet granulation
the various improved equipment which combines several processing steps (mixing,
granulation and/or drying) are used. They are the "Mixer granulator" and "High shear mixing
machine".

GRANULATION
Following particle size reduction and blending, the formulation may be granulated,
which provides homogeneity of drug distribution in blend. This process also is very important
and needs experience to attain proper quality of granule before tableting, quality of granule
determines the smooth and trouble free process of tablets manufacturing. Please keep in
mind, if one cannot have experience of granulation, can make great troubles for tableting
press operator.






WET GRANULATION:

Wet granulation has some basic steps in common with dry granulation :a) Commination. b)
Blending. c) Milling. d) Lubrication.

The additional steps necessary are the preparation and addition of a granulation solution, wet
screening, and drying.
Granulating liquid may be deionized water, deionized water and alcohol, or other
appropriate liquid.
Granulating liquid may be used to introduce binders, such as gums or starches
or colouring agents.
After addition of granulating liquid, mixing or kneading continues until uniform
dispersion of liquid is attained.
Wet screening or milling may be employed to break up moist mass into appropriate
size granules for drying
Wet granules are then dried in appropriate racks for oven drying, in pots for fluid bed
drying or in other suitable equipment.
Material is then dry screened or milled to achieve desired particle size.
Lubricants may have been included in the wet stage; if not they may be incorporated
at this time, prior to final batch blending.
Other procedures for wet granulation may be employed. Basically, all these methods
combine wetting the powders to form granules and then drying the granules in the
same piece of equipment.









DRYING
Drying is a most important step in the formulation and development of
pharmaceutical product. It is important to keep the residual moisture low enough to prevent
product deterioration and ensure free flowing properties.
The commonly used dryers include Fluidized bed dryer, Vacuum tray dryer, Microwave
dryer, Spray dryer, Freeze dryer, Turbo - tray dryer, Pan dryer, etc.

TABLET COMPRESSION

After the preparation of granules (in case of wet granulation) or sized slugs (in case of
dry granulation) or mixing of ingredients (in case of direct compression), they are
compressed to get final product. The compression is done either by single punch machine
(stamping press) or by multi station machine (rotary press).
The tablet press is a high-speed mechanical device. It 'squeezes' the ingredients into
the required tablet shape with extreme precision. It can make the tablet in many shapes,
although they are usually round or oval. Also, it can press the name of the manufacturer or
the product into the top of the tablet.
Each tablet is made by pressing the granules inside a die, made up of hardened steel. The die
is a disc shape with a hole cut through its centre. The powder is compressed in the centre of
the die by two hardened steel punches that fit into the top and bottom of the die.
The punches and dies are fixed to a turret that spins round. As it spins, the punches
are driven together by two fixed cams - an upper cam and lower cam. The top of the upper
punch (the punch head) sits on the upper cam edge .The bottom of the lower punch sits on the
lower cam edge. The shapes of the two cams determine the sequence of movements of the
two punches. This sequence is repeated over and over because the turret is spinning round.
The force exerted on the ingredients in the dies is very carefully controlled. This
ensures that each tablet is perfectly formed. Because of the high speeds, they need very
sophisticated lubrication systems. The lubricating oil is recycled and filtered to ensure a
continuous supply.


COATING
Tablet coating is the key step involved in the manufacturing of tablets having
controlled release, delayed release profiles. The tablet coating have number of advantages
like masking odour, taste, colour of the drug, providing physical and chemical protection to
drug, Protecting drug from the gastric environment. 3 primary components of tablet coating
are tablet properties, coating process and coating composition. Tablets are usually coated in
horizontal rotating pan with coating solution is either directly poured or sprayed on to them.
The amount of coating on the surface of a tablet is critical to the effectiveness of the oral
dosage form. Recent trends in tablet coating focuses on overcoming disadvantage of solvent
based coating. This article concerns with the coating process, equipment involved, coated
tablets evaluation and specialized coating techniques.
Coatings generally consist of a sugar or cellulose based binder, plasticizer, film
forming agent and colorant. These are supplied in granulated or powder form for dispersion
in aqueous or organic solvents at concentration varying from 10 -20% depending on the
desired properties and formula.


COATING EQUIPMENTS: -

For coating process use of one of the 3 types of following equipment.
1) Conventional coating pan. 2) The perforated coating pan. 3) The fluidized bed coater.

1) Conventional coating pan: - Improvements in conventional pan are Pellegrino system
which has a baffled pan and diffuser the immersion sword system and the immersion tube
system all of them have enhanced drying efficiency compared to older models. The newer
models are completely enclosed.

2) The perforated coating pan: - The e.g. in this class are Accela-cota, Hi-Coater system
Diracoater and the Glatt coater.

3) The fluidized bed coater: - The fluidized bed coaters have enhanced drying efficiency
fluidization of tablet mass is achieved by columnar chamber by the upward movement of the


drying air. The movement of the tablets is upward through the centre of the camber. Then
they fall toward the chamber wall and move downward to re-enter into air stream at the
bottom of the chamber. It has a basically two spray application systems they are (1) high
pressure airless (2) low pressure air atomized.

COATING TECHNIQUES: -

Generally three methods are used for tablet coating A) Sugar coating. B) Film
coating. C) Enteric coating.

A) Sugar coating: -
I. Sealing/Water proofing: provides a moisture barrier and harden the tablet surface.
II. Sub coating causes a rapid build up to round off the tablet edges.
III. Grossing/Smoothing: smoothes out the sub coated surface and increases the tablet size to
Predetermine dimension.
IV. Colouring gives the tablet its colour and finished size.
V. Polishing produces the characteristics gloss.

B) Film coating: - Film coating and the sugar coating share same equipment and the process
parameters. There are basically 2 methods of film coating they are
I. Pan pour methods: Tablets coated by pan pour method subjected to alternate solution
application, mixing and drying steps are similar to pan pour sugar coating. This method is
relatively slow and relies heavily on the skill of operator.
II. Pan-spray methods: The introduction of spraying equipment was the next evolution in
improving the film coating process allows for automated control of liquid application. Broad
flat spray patterns are usually chosen by appropriate nozzle systems.

C) Enteric coating: - ideal properties of enteric coating material are:
1)Resistant to gastric fluids.
2) Compatibility with most of the coating solutions
3) Non toxicity.
4) Low cost.


5) Ease of application
6) Formation of continuous film.

Film coating formulations usually contain the following components:
1. Polymer
2. Plasticizer
3. Colorant
4. Opacifier
5. Solvent
6. Vehicle

PACKAGING

Pharmaceutical manufacturers have to pack their medicines before they can be sent
out for distribution. The type of packaging will depend on the formulation of the medicine.
'Blister packs' are a common form of packaging used for a wide variety of products. They are
safe and easy to use and they allow the consumer to see the contents without opening the
pack. Many pharmaceutical companies use a standard size of blister pack. This saves the cost
of different tools and to change the production machinery between products. Sometimes the
pack may be perforated so that individual tablets can be detached. This means that the expiry
date and the name of the product have to be printed on each part of the package. The blister
pack itself must remain absolutely flat as it travels through the packaging processes,
especially when it is inserted into a carton. This poses interesting problems for the designers.
Extra ribs are added to the blister pack to improve its stiffness.







CONCLUSION:

Manufacturing process of a tablet is very important. The above process shows that
production process is committed to sustainable and environmental practices as part of its
overall aim to act responsibly. It shows commitment and progress towards key targets of
sustainability as well as encouraging sustainable decision
These specialised experimental design using the above steps are the only process
variable is an efficient strategy to quickly determine the optimal design process for tablet
manufacturing. This method can be applied for any tablet manufacturing method.