Audit of Coating

Tablet coating:
• Tablet coating is defined as “ covering the tablets with one or more
layers of mixture of various substances such as natural or synthetic
resins ,gums ,inactive and insoluble filler, sugar, plasticizer, polyhydric
alcohol ,waxes , authorized colour and some times flavour .’’
• Tablet coating is the application of coating material to the exterior of
a tablet with the intention of conferring benefits and properties to a
dosage form over the uncoated variety.”
• As per I.P “Tablet coated with mixture of various substances such as
resins, gums, inactive and insoluble fillers, sugars, waxes, etc.”

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Objectives Of Tablet Coating
• Mask Bitter taste
• Mask unpleasant odour.
• Protecting the drug from surroundings.
• To increase the Stability.
• Handling & ease of ingesting by patients.
• Mechanical protection from breakage.
• Avoid Light incompatibility.
• Protection from Environmental Oxidation.
• To modifying the drug release profile.
• For Product identity.

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Components Considered In Tablet Coating:
Tablet properties
Coating process:
1. Coating Equipment
2. Parameters of the coating process
3. Facility and ancillary equipment
4. Automation in coating process.
Coating compositions

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Coating Process:
• Tablet coating is the application of coating composition to a moving
bed of the tablets with concurrent use of heated air to facilitate
evaporation of the solvent.
• The process and equipment must provide:
1. Distribution of the liquid coating formulation over the whole of the
available tablet surface (ladling, Spraying).
2. Continuous mixing of the tablet load in order to achieve an evenly
coated product (rotation).
3. Continuous drying to solidify the film quickly (hot air).
4. Removal of solvent vapour (plus dust generated, plus used drying air
and atomizing air).

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Tablet Coating Process:

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Equipment:
Three types of coating equipments are used.
• Standard (conventional) coating pan
• Perforated coating pan
• Fluidized bed (air suspension) coater

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Standard (conventional) coating pan:

• It is also known as conventional pan system

• Circular metal pan(mounted angularly on a stand)
• 8-60 inches in diameter
• Rotated on its horizontal axis by a motor
• Heated air is directed into the pan & on to the tablet bed surface
and is exhausted by means of ducts through the front of the
pan.
• Coating solution are applied to the tablets by ladling or spraying
the material on to the rotating tablet bed.

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Perforated pan system:

• This system make use of perforated or partially perforated drum (pan)

that rotates on its horizontal axis in an enclosed housing.
• This type of coating system are more efficient in drying as compared
to the conventional system.
• With such system mark decrease in coating time can be achieved.

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Fluidized bed (air suspension) coater
• In this system fluidization of the tablet mass is achieved in a columnar
chamber by the upward flow of drying air.
• The air flow is controlled, so that more air enters the centre of the
column, causing the tablets to rise in the centre.
• The movement of tablets is upward trough the centre of the chamber.
• They then fall towards the chamber wall,
• Move downwards to re enter the air stream At the bottom of the
chamber.
• Coating solutions are applied from a spray nozzle which is located at
the bottom of the chamber. {Or }
• are sprayed onto the top of the Cascading tablet bed by nozzles
located in the upper region of the chamber.

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Coating Parameters:
• During coating the tablets move through an application zone in which
a portion of the tablets receive some coating.
• Most of the time tablets are in drying mode moving away from the
application zone and recycled repeatedly through the application
zone.
• In the coating operation (continuous) an equilibrium is maintained
between coating composition application rate and the rate of
evaporation of the solvent. Deviation from this equilibrium results in
serious coating problems. These two parameters can be adjusted by;
 SprayGun position: 6-18 inches from the bed, 450 angle to the tablet
bed. Not overlapping fan width nor to far.

 Effect of pan load: under loading the pan will result in situation
where the tablet does not cover fully the exhaust plenum, and the
majority of the drying air stream will bypass the tablet bed and drying
efficiency will be low. 13
 Air volume and temperature: Drying is controlled by the quantity
and temperature of the drying hot air, and the quantity of exhaust
air. It is important to balance the inlet and exhaust air flow rates
such that there is slight negative pressure in the chamber. Also the
temperature difference between the inlet and exhaust must be
with in 20-30oC. It is important to monitor the following three
temperatures.
1. Inlet Air temperature
2. Tablet Bed temperature (most critical)
3. Exhaust air temperature

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Coating composition

1. Polymer (film former)

2. Plasticizer
3. Colouring/opacifying agent
4. Solvent
5. Others (surfactants, flavours, sweetening agent, active ingredients
and preservatives.)

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 Polymers/Film formers

• The function of the polymer is to provide main structure and basic

physical and chemical properties to the coating.
• Polymer viscosity is very important specially in aqueous coating we
need to minimize the water concentration, it is to shorten the
process time and to minimize product exposure to the moisture
(moisture sensitive product). But the coating composition with
viscosity above 500 cps are difficult to atomize and will not produce
smooth product.
• Therefore polymers with low viscosity are preferred.
• Eg. HPMC, Ethyl cellulose, HPC, PVP, CAP, PVAP.

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 Plasticizer
• The function of plasticizer is to modify the basic mechanical
properties of the polymer. Plasticizers have high affinity for the
polymer they are also called nonvolatile solvents.
• There are two techniques to modify the plasticity of the film former;
1.Internal plasticizing

2.External plasticizing

• In the former technique chemical modification is brought in the

polymer which alters the physical properties of the polymer i.e. elastic
modulus. In later technique other substances are used as plasticizer in
the formulation. When the plasticizer is used in correct concentration
it imparts flexibility by relieving the molecular rigidity. Commonly 10%
of polymer concentration is used.
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 Examples include
• Castor Oil
• PEG 200 and 400
• Propylene glycol
• Glycerine
• Polysorbates (tweens)
• Sorbitan esters (spans)

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 Coloring and opacifying agent
• The function of these ingredients is to enhance the product quality.
They provide
1. Product identification
2. Protect the core from light and moisture
3. Theyincrease the solid concentration with any impact on viscosity
thus reducing the drying time. They are either soluble or form fine
suspension in the solvent system. For uniform distribution the
particle size must be <10 microns.
The most common colorants used are FD&C or D&C certified, these are
either dyes or lakes of dyes.

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 Solvents
• The function of the solvent is to dissolve or disperse the polymers and
other additives and transfer them to the surface of substrate (core) the
ideal characteristics are
1.Itshould either dissolve or disperse the polymer system and other
ingredients.
2.Small concentration of polymer (2-10%) should not high viscous
solution
3.It
should be colorless, tasteless, odorless, inexpensive, inert and
noninflammable.
4.Should have rapid drying rate
5.Shouldnot have environmental impact.
The most widely solvents used either alone are in combination are
water, ethanol, methanol, isopropyl alcohol, chloroform , acetone 20,
methyl ethyl ketone and methylene chloride.
CHECKLIST OF TABLET COATING
 Personnel:
• Is coating area adequately staffed?
• Is there proper supervision in coating area?
• Is updated technical staff list is available with the following
information- name, qualification, years of experience of pharmacists.
• Is this examination done periodically?
• Is an employee whose states of health is doubtful immediately
removed from the work site until she/he has recovered?
• Do they wear clean-white clothes?
• Do all personnel receive up-dated GMP training?
• Then proper training records should be sustained.
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Premises:
• Is the coating area so constructed and maintained to protect against
insects, rodents, birds and other animals?
• Is there an adequate working space ?
• Are facilities properly constructed to smooth operation and adequate
cleaning?
• Are lighting and ventilation adequately designed and installed?
• Are floor, wall and ceilings constructed of materials which will
facilitate easy cleaning and if necessary disinfections?

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Facility and Utilities:

• Whether adequate space is designed to support proper flow of all the

coating operations?
• Whether design of space is such that it does not hinder the working
environment?
• Whether equipments are allotted proper site and space?
• Whether proper utilities like adequate power supply, water system,
light, air conditioning is supplied?

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Sanitation:

• Whether proper cleaning is maintained ?

• Whether cleaning records are available ?
• Which disinfectants are used for cleaning purposes?
• Whether one or more disinfectants are used and at what intervals?

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Equipments:
• Whether SOPs of all the equipments are available?
• Whether qualification records of equipments are sustained?
• Whether proper cleaning and maintenance of equipments is
maintained?
• Whether equipments are properly designed and stationed?
• Whether PLC system is validated?

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 Process parameter:
 Check that coating Suite are properly cleaned & dry.
 Process validation parameters should be checked.
 All correct documents are available
 Check for QC approved (Green) status label and the re-testing date
on the container.
 Check that all balance are calibrated.
 Check that correct dispensed Raw Material is available
 Check the gross weight of the container to be dispensed and the
quantity matches with the labelled quantity.
 Monitor that during material handling the operator should wear
mask and gloves because any alteration can cause adverse effects.
 Any deviation during coating process should be immediately take
initiative to resolve. Proper CAPA should be implemented.
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 Monitor Inlet & Outlet of bed temperatures.
 Monitor Relative humidity.
 Monitor Atomization air pressure.
 Check Pan speed.
 Check Liquid spray rate.
 Gun nozzles check.
 Monitor Spray gun calibration.
 Check Solid content of coating solution.
 Check Nozzle-to-bed distance.
 Check Droplet size.
 Monitor Drying time
 Monitor every step of coating.

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 Quality Checklist for coated tablet:
 Is there any Colour variation appear?
 Check following defects of coated tablet.
Twinning
Cracking
Capping
Lamination
Sticking
Orange peel
 Check Broken tablet is there?
 Is there any black spot or oil spot of coating is appear?
 Whether thickness of tablets are measured during the coating
process., i.e after 1st coating, 2nd coating?
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Environment Monitoring:
• Whether proper air flow is maintained?
• Whether surrounding environment is free from contamination?
• Whether all the parameters like Temperature, Moisture and Humidity
levels are controlled?
• Whether a general written documents for environmental Monitoring
are available?

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Documentation:
Various documents should be checked:
• Serial number of Batch Record
• Name of the product
• Reference to Master Formula Record
• Batch/Lot number
• Batch/Lot size
• Date of commencement and completion of manufacture
• Date of manufacture and assigned date of expiry
• Date of each step in manufacturing
• Names of all ingredients with grade given by the quality control department
• Quality of all ingredients
• Control reference numbers for all ingredients
• Environmental Monitoring records
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