Pharmaceutical Coating Project

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PHARMACEUTICAL
COATING PROJECT
Submitted by:
MD ABUL HAIDER SHIPAR
ASHISH WADHWA
CHERIAN VARUGHESE
NARINDER KAUR
NIRANJANI THAYAPARAN
MT13-3
TORONTO INSTITUTE OF
PHARMACEUTICAL TECHNOLOGY
2013 – 2014
Submitted by: Shipar, MAH; Ashish, W; Cherian, V; Narinder, K and Niranjani, T. (MT13 - 3)
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CONTENTS
Page
TITLE PAGE ………………………………………………………………………………… 1
CONTENTS ………………………………………………………………………………….. 2
SUMMARY …………………………………………………………………………………... 3
“SECTION A”
SA1. INTRODUCTION …………………………………………………………………… 5

SA1.1. TABLET COATING ………………………………………………………………… 5
SA1.2. TYPES OF TABLET COATING …………………………………………………... 5
SA2. FACTORS INVOLVED IN COATING PROCESS ………………………………. 6
SA2.1. Tablet properties ……………………………………………………………………….6
SA2.2. Coating process ……………………………………………………………………….. 7
SA2.3. Coating composition ………………………………………………………………….. 12
SA3. INCORPORATION OF VARIABLES INTO A VALIDATION PROJECT …… 13
SA4. CONCLUSION ……………………………………………………………………….. 13
“SECTION B”
SB1. INTRODUCTION ……………………………………………………………………. 15

SB1.1. QUALIFICATION AND VALIDATION …………………………………………… 15
SB1.2. SCOPE AND OBJECTIVE OF QUALIFICATION AND VALIDATION ………. 15
SB1.3. TYPES OF VALIDATION …………………………………………………………... 16
SB1.4. TYPES OF QUALIFICATION ……………………………………………………… 18
SB2. INSTALLATION QUALIFICATION (IQ) ……………………………………….... 20
SB2.1. INSTALLATION QUALIFICATION (IQ) CHECKLIST FOR COATING
SYSTEM ………………………………………………………………………………. 20
SB2.2. INFORMATION/ DOCUMENTS INCLUDED IN THE COATING SYSTEM
FILE …………………………………………………………………………………… 21
SB3. CONCLUSION ………………………………………………………………………... 22
“SECTION C”
SC1. INTRODUCTION ……………………………………………………………………. 24

SC1.1. OPERATIONAL QUALIFICATION (OQ) ………………………………………… 24
SC2. FLOWCHART OF OPERATIONAL QUALIFICATION (OQ) FOR THE
COATING SYSTEM …………………………………………………………………. 24
SC3. CONCLUSION ……………………………………………………………………….. 24
REFERENCES ……………………………………………………………………………….. 26
FIGURES
Figure 1: Schematic diagram of coating machine ……………………………………………… 8
Figure 2: Flowchart of Operational Qualification (OQ) for the coating system ……………… 25
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SUMMARY
The present studied project is divided into following three sections:
SECTION A:
Factors within the coating process that might introduce variability into the quality of film
coated tablets are identified in this section. The effect of each variable is explained briefly.
Moreover, incorporation of these variables into a validation project is pointed out.
SECTION B:
In this section, process/system qualification and validation are described primarily. An
Installation Qualification (IQ) checklist that would be appropriate to use for coating system is
prepared and presented. Information/documents that would be included in the coating system file
are also mentioned.
SECTION C:
Basic information on Operational Qualification (OQ) is described in this section.
Moreover, the flowchart of Operational Qualification (OQ) for tablet coating system is provided.
This studied project is assumed helpful to understand the overall coating process and
factors affecting the coating process. Moreover, qualification and validation process, relevant to
the coating process, can also be obvious from it.
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SECTION A
FACTORS AFFECTING THE COATING PROCESS
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SA1. INTRODUCTION:1–6
SA1.1. TABLET COATING:
Tablet coating is the application of a coating material to the exterior of a tablet with the
intention of conferring benefits and properties the dosage form over the uncoated variety. The
decision to coat the tablet is usually based on one or more of the following objective:
i) To musk the unpleasant taste, odour or color of the drug,
ii) To provide physical and chemical protection for the drug,
iii) To control the release as an enteric coating or sustained release or more usually to
coated multi particulates,
iv) To protect the drug from gastric environment of the stomach with an acid resistant
enteric coating,
v) To improve the physical elegance by use of special colors,
vi) To assist and facilitate the identification of the drug,
vii) To ease the process of blistering.
The reason for coating is non-functional and functional. The major feature that
distinguishes a functional coat from a non-functional coat is the impact of the coat on drug
release or bioavailability if the drug substance.
SA1.2. TYPES OF TABLET COATING:
Different types of tablet coatings can be used for tablet coating, e.g.
1. Sugar coating: It is a multistage process and can be divided into the following steps:
i) sealing/water proofing of the tablet cores,
ii) sub coating,
iii) smoothing,
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iv) coloring, and
v) polishing.
2. Film coating: This technique involves spraying a solution of polymer, pigments, plasticizers
on to a rotated, mixed tablet bed forms a thin, uniform film on tablet surface. Coating suspension
formulation typically comprises polymer, plasticizer, colorants and solvents.
3. Enteric coating: This technique is used to protect the tablet from disintegration in the acid
environment of the stomach for one or more of the following reasons:
i) Prevention of acid attack on active constituents unstable at low pH,
ii) To protect the stomach from the irritant effect of certain drugs,
iii) To facilitate absorption of a drug that is preferentially absorbed distal to the stomach,
iv) Polymers are insoluble in aqueous media at low pH, but as the pH rises they
experience a sharp, well defined increase in solubility at a specific pH.
4. Press coating: In this technique, compression is to form coat around a pre-formed core. It is
mainly used to separate chemically incompatible materials.
SA2. FACTORS INVOLVED IN COATING PROCESS:7–17
There are three primary components involved in tablet coating:
SA2.1. Tablet properties:
The tablets that are to be coated must possess the proper physical characteristics. To
tolerate the intense attrition of tablet striking other tablets or the wall of the coating equipment,
the tablets must be resistance to abrasion and chipping. Tablet surfaces that are brittle, soften in
the presence of heat are unacceptable for film coating. Tablets must have smooth surfaces and
free from any imperfections. In addition to smooth surfaces, physical shape of the tablet is also
important. The ideal shape of the tablet is a sphere, which allows the tablet to roll freely in the
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coating pan with minimum tablet to tablet contact. The worst shape is the flat faced tablets in
which case coating materials would collect between the surfaces to glue them together. For this
reason, coated tablets have rounded surfaces. The more convex the surface, the few difficulties
will be encountered with tablet agglomeration. Hydrophobic tablet surfaces are difficult to coat
with aqueous based coating that do not wet the surface. Addition of surfactant improves
adhesion.
SA2.2. Coating process:
In tablet coating, a coating composition is applied to a moving bed of tablets with the
concurrent use of heated air to facilitate evaporation of the solvent. The distribution of the
coating is accomplished by the tablets either perpendicular (coating pan) or vertical (air
suspension).
Coating at any scale involves the understanding of the interactions between the product
being coated, the film coating formulation, the equipment installation and the processing
parameters. When a film coating process is transferred and scaled from the laboratory to
production equipment many factors must be well thought-out.
During the coating process, various variables relevant to the process equipment can be in
effect (Figure 1).
The variable inputs to a film coating process derived from differences in equipment
installations include but are not limited to:
i) Cleanliness of coating station and equipment: The cleanliness of coating station
(room) and equipment affects the overall coating process that may result in tablets with defective
coatings. Before starting the coating process, it is required to make sure that the coating station
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and equipments are cleaned and dried properly as very small changes in any parameter can lead
to big differences in the result.
Figure 1: Schematic diagram of coating machine.
ii) Coating station condition: Temperature, relative humidity, differential pressure and
air quality of the coating station (room) can affect the efficiency of the equipment and final
product characteristics.
iii) Inlet air volume/ flow rate: The air volume and/or air flow rate affects the dying
efficiency of the coating unit, and subsequently, the quality of the coated tablets. An increase of
the inlet air flow rate causes a linear increase in the tablet bed temperature, increasing the
evaporation capacity of the coating unit and eliminating over wetting problems of tablets.
Therefore, the inlet air volume and/or air flow rate should be maintained at an optimum rate.
iv) Inlet air temperature: It is important the inlet air temperature or pan air temperature
is monitored, because the spray-tablet core interface is where problems manifest during aqueous
film coating. The spray rate of coating solution, inlet air flow rate and inlet air temperature have
a significant effect on the tablet bed surface temperature, whereas spraying air pressure and pan
speed do not. During the coating process, the initiation of spraying causes a rapid drop in the pan
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air temperature until an equilibrium is attained. The pan air temperature, relevant to the inlet air
temperature, affects the drying efficiency (evaporation of the solvent, i.e. water) of the coating
pan and the uniformity of coatings. High inlet air temperature increases the drying efficiency of
the aqueous film coating process and a decrease in the water penetration into the tablet core
resulting in decrease of the core tablet porosity, tensile strength and residual moisture content of
coated tablets. Excessive air temperature increases the premature drying and subsequently
decreases the coating efficiency. Measuring the pan air temperature helps to manage the
optimum conditions during the coating process and consequently enables predicting possible
drying or over wetting problems which may result in poor appearance of the film or may have
unfavourable effects on the moisture and heat sensitive tablet cores.
v) Inlet air humidity: It is obvious that the humidity of coating process air is an
important factor affecting the penetration and evaporation of water on the tablet surface. The
water removal efficiency of the coating process is linearly correlated with the residual moisture
content, tensile strength and porosity of the coated tablet.
vi) Outlet air volume/ flow rate: Outlet air volume and/or flow rate or velocity may
have an intense effect on drying efficiency. Higher and lower outlet air flow will cause increase
and decrease in drying efficiency, respectively. Therefore, outlet airflow should be controlled
accordingly.
vii) Nozzle orifice size: For bigger nozzle orifice size, more coating solution can be
sprayed resulting in over wetting problems. It may result in unfavourable effects such as over
wetting, sticking, etc. On the other hand, due to spraying of insufficient coating solution for
smaller nozzle orifice size can result in inadequate coating process. Therefore, during the coating
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process, the spry rate of the coating solution should be in consistent with the size of nozzle
orifice.
viii) Number of spray gun: The number of spray gun mainly depends on the batch size
that may introduce variability into the quality of film coated tablets through varying the amount
of sprayed coating solution during the process according to their number and distance in
positioning.
ix) Distance between spray guns: If the distance between spry guns is higher, all tablets
will not be wetted properly during spraying the coating solution. On the other hand, over wetting
may take place when the distance between spry guns is not enough from each other.
x) Distance between spray gun and tablets: Higher distance of the spray gun from
tablets will cause evaporation of the coating solution before wetting the tablets properly resulting
in poorer coating process. On the other hand, over wetting can take place due to lower distance
of the spray gun from tablets causing subsequent poorer coating process. Therefore, distance of
the spray gun from tablets should carefully be optimized for proper tablet coating.
xi) Spray rate: The spray rate is a significant parameter since it impacts the moisture
content of the formed coating and the quality and uniformity of the film. The spray can not be
too low or too high. It is also depend on the viscosity of the coating solution. A low coating
liquid spray rate causes incomplete coalescence of polymer due to insufficient wetting, which
could effect in brittle films. A high coating liquid spray rate may result in over wetting of the
tablet surface and subsequent problems such as picking and sticking. If the spray rate is high and
the tablet surface temperature is low, films are not formed during the spraying but the post
drying phase, and rapid drying often produces cracks in the films. However, variation in batch
size needs change in the required flow rate of coating solution.
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xii) Atomizing air pressure: In general, increasing the spraying air pressure decreases
the surface roughness of coated tablets and produces denser and thinner films. If spraying air
pressure is excessive, the spray loss is great, the formed droplets are very fine and could spray-
dry before reaching the tablet bed, resulting in inadequate droplet spreading and coalescence. If
spraying air pressure is inadequate, the film thickness and thickness variation are greater possibly
due to change in the film density and smaller spray loss. In addition, with low spraying air
pressure big droplets could locally over wet the tablet surface and cause tablets to stick to each
other.
xiii) Coating pan dimensions: Three types of coating pans are generally used for coating
process, e.g.
A) Conventional pans,
B) Perforated pans, and
C) Fluidized-bed processors:
Three types, e.g.
 Fluidized-bed top spray,
 Fluidized-bed bottom spray, and
 Fluidized-bed tangential spray.
Dimensions of the different types of coating pans should have significant affect on the
coating materials based on their characteristics. Therefore, coating pan should be selected
carefully before coating process depending on the characteristic of the coating materials.
xiv) Rotating speed of coating pan: Increasing the rotating speed of the pan improves
the mixing of tablets. The pan speed affects the time the tablets spend on the spraying zone and
the homogeneous distribution of the coating solution on the surface of each tablet throughout the
batch. Increasing the pan speed decreases the thickness variation and increase the uniformity of
coatings. However, higher rotating speed of the pan may cause the tablet to undergo unnecessary
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attrition and breakage. Therefore, hardness of tablet should be appropriate with the speed.
Moreover, variation in batch size changes the required pan speed.
xv) Skill and training on coating: In most of the cases, the film coating process is not
given the due importance. Lots of efforts are utilized, and technical supervision is also carried
out, to the general hygiene, GMP, record keeping, the optimized granulation and compression
processes, and very rarely regarding the operational work. Hence, a major factor which may
affect the coating quality is the active supervision of the operation, and the skill and training of
the operators. Consideration should be given to the training of coating process. A well defined
and detailed training before assigned the responsibility, and then, some kind of refreshing course
to ensure filling up the knowledge gaps can minimize the factors within the coating process that
may introduce variability into the quality of film coated tablets.
SA2.3. Coating composition:
A typical film coating mixture usually composed of the following:
i) Film former: A film former is usually a polymer. An ideal film former should have the
following attributes:
 Solubility in solvent of choice.

 Good solubility in aqueous fluids to facilitate the dissolution of active ingredient.
 Low viscosity for a given concentration.
 Capacity to produce an elegant looking product.
 Stability in the presence of heat, moisture and air.
 Essentially having no color, taste or odour.
 Compatibility with common coating solution additives.
 Non-toxicity with no pharmacological activity.
ii) Plasticizer: Plasticizers are generally added to film coating formulations to modify the
physical properties of the polymer to make it more usable. One important property is their ability
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to decrease film brittleness. The type of plasticizer and its ratio to polymer can be optimized. The
recommended levels of plasticizers range from 1% to 50% by weight of film former.
iii) Solvent: The function of a solvent system is to dissolve or disperse the polymer and
other additives. The most widely used solvents, either alone or combination are water, ethanol,
methanol, chloroform, acetone, methylene chloride, methyl ethyl ketone, etc. Ideally the solvent
should have rapid drying rate without any impact on the environment.
iv) Colorants: The most common colorants in use are certified food drug and cosmetic
colorants. The concentration of the colorant in the coating solution depends on the color shade
desired usually from 0.01% to 2.0%.
SA3. INCORPORATION OF VARIABLES INTO A VALIDATION PROJECT:
The above mentioned variables that may affect the quality of film coated tablets can be
incorporated into a validation project by the followings:
i) At least first three consecutive batches be carried out,
ii) Proper documentation of all the process should be produced to obtain optimum
parameters that will enhance the quality of the coating process,
iii) Ensuring the documentation of the rational for changing the experimental method.
iv) Determination of the critical control points for the variables such as inlet air
temperature, inlet air volume/flow rate, inlet air relative humidity, atomizing air pressure, pan
speed, etc.
SA4. CONCLUSION:
Coating technology, e.g. film coating technology is now a days very important in the
field of pharmacy particularly in formulation development. Process parameters and coating
composition play an important role in coating of tablets. Therefore, to get good final quality of
coated tablets, it is necessary to optimize the parameters.
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SECTION B
QUALIFICATION AND VALIDATION IN THE COATING PROCESS
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SB1. INTRODUCTION:
SB1.1. QUALIFICATION AND VALIDATION:18–23
Qualification is a process of assurance that the specific system, premises or equipment
are able to achieve the predetermined acceptance criteria to confirm the attributes what it
purports to do. Qualification is documented evidence that a specific equipment, facility or system
is fit/ready for intended use. Things that are required to be qualified are equipments, systems etc.
On the other hand, validation is establishing a documented evidence to provide a high
degree of assurance that a specific system, process or facility will consistently produce a product
meeting its predetermined specifications and quality attributes. Validation is documenting that
the way equipment, facility or system used will result in product meeting its predetermined
specifications and quality attributes. Process/procedures (the way through which things are used)
are validated. Before performing validation on a process, the equipment has to be sure that it has
passed qualification.
SB1.2. SCOPE AND OBJECTIVE OF QUALIFICATION AND VALIDATION:
Any food and drugs regulatory agency not only asks. For a product, especially a food or
pharmaceutical product, should meets its specification. At the same time, a process, procedures,
intermediate stages of inspections, testing, adapted during manufacturing should be designed
such that when they are adapted they produce consistently similar, reproducible, desired results
that meets the quality standard of product being manufactured. Such procedures are developed
through the process of validation and qualification. This is to maintain and assuring higher
degree of quality of food and drug products. A properly designed system will provide a high
degree of assurance that every step, process, and change has been properly evaluated before its
implementation. Testing a sample of a final product is not considered sufficient evidence that
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every product within a batch meets the required specification. The qualification and validation
process should be established and provide documented evidence that
 The premises, the supporting utilities, the equipment and the process have been designed
in accordance with the requirements of GMP. This normally constitutes Design Qualification
(DQ).
 The premises, the supporting utilities and the equipment have been built and installed in
compliance with their design specifications. This constitutes Installation Qualification (DQ).
 The premises, the supporting utilities and the equipment operate in accordance with their
design specifications. This constitutes Operational Qualification (OQ).
 A specific process will consistently produce a product meeting its predetermined
specifications and quality attributes. This constitutes Process Qualification (PQ).
 Any aspect, including significant changes that may affect the quality of the product
directly or indirectly, of the premises, the facilities, the equipment or the processes should be
qualified and validated.
 Qualification and validation can not be considered once-off exercise, e.g. the start up of a
new operation. An ongoing program should follow its first implementation.
SB1.3. TYPES OF VALIDATION:
The guidelines on general principles of process validation mentions four types of
validation:
1. Prospective validation or premarket validation:
Establishing documented evidence prior to process implementation that a system does
what it proposed to do based on pre-planned protocols. This approach to validation is normally
undertaken whenever the process for a new formula (or within a new facility) must be validated
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before routine pharmaceutical production commences. In fact, validation of a process by this
approach often leads to transfer of the manufacturing process from the development function to
production.
2. Retrospective validation:
Retrospective validation is used for facilities, processes, and process controls in operation
use that have not undergone a formally documented validation process. Validation of these
facilities, processes, and process controls is possible using historical data to provide the
necessary documentary evidence that the process is doing what it is believed to do. Therefore,
this type of validation is only acceptable for well-established processes and will be inappropriate
where there have been recent changes in the composition of product, operating processes or
equipment. This approach is rarely been used today because it is very unlikely that any existing
product has not been subjected to the Prospective validation process. It is used only for the audit
of a validated process.
3. Concurrent validation:
Concurrent validation is used for establishing documented evidence that a facility and
processes do what they purport to do, based on information generated during actual imputation
of the process. This approach involves monitoring of critical processing steps and end product
testing of current production, to show that the manufacturing process is in a state of control.
4. Revalidation:
Revalidation means repeating the original validation effort or any part of it, and includes
investigative review of existing performance data. This approach is essential to maintain the
validated status of the plant, equipment, manufacturing processes and computer systems.
Possible reasons for starting the revalidation process include:
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 The transfer of a product from one plant to another.
 Changes to the product, the plant, the manufacturing process, the cleaning
process, or other changes that could affect product quality.
 The necessity of periodic checking of the validation results.
 Significant (usually order of magnitude) increase or decrease in batch size.
 Sequential batches that fail to meet product and process specifications.
 The scope of revalidation procedures depends on the extent of the changes and the
effect upon the product.
Since a wide variety of procedures, processes and activities need to be validated the field
of validation can further be divided into a number of subsections including the following:
i) Equipment validation,
ii) Facilities validation,
iii) HVAC system validation,
iv) Cleaning validation,
v) Process validation,
vi) Analytical method validation,
vii) Computer system validation,
viii) Packaging validation, and
ix) Cold chain validation.
SB1.4. TYPES OF QUALIFICATION:
The activity of qualifying systems and equipment is divided into a number of subsections
including the following:
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1. Design Qualification (DQ):
Demonstrates that the proposed design (or the existing design for an off-the-shelf item)
will satisfy all the requirements that are defined and detailed in the User Requirements
Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before
construction (or procurement) of the new design can be authorised.
2. Component Qualification (CQ):
This term refers to the manufacturing of auxiliary components to ensure that they are
manufactured to the correct design criteria. This could include packaging components such as
folding cartons, shipping cases, labels or even phase change material. All of these components
must have some type of random inspection to ensure that the third party manufacturer's process
is consistently producing components that are used in the world of GMP at drug or biologic
manufacturer.
3. Installation Qualification (IQ):
Demonstrates that the process or equipment meets all specifications, is installed correctly,
and all required components and documentation needed for continued operation are installed and
in place.
4. Operational Qualification (OQ):
Demonstrates that all facets of the process or equipment are operating correctly.
5. Performance Qualification (PQ):
Demonstrates that the process or equipment performs as intended in a consistent manner
over time.
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SB2. INSTALLATION QUALIFICATION (IQ):
The Installation qualification (IQ) execution verifies that the equipment, and its ancillary
systems or sub-systems have been installed in accordance with installation drawings and or
specifications. It further details a list of all the Continued Good Manufacturing Procedure
(cGMP) requirements that are applicable to this particular installation qualification. These
requirements must all be satisfied before the IQ can be completed and the qualification process is
allowed to progress to the execution of the Operational Qualification (OQ). IQ protocol comes
with an interactive Standard Operating Procedure (SOP) as an attached prefixed document. As
the requirements specified in the SOP are followed, the actual IQ protocol is completed. This
makes it a really easy and straight forward document to use. The IQ is normally a stand alone
document, however, with careful pre-planning, certain aspects of the IQ activities can be
integrated with the Factory Acceptance Testing (FAT), and the equipment Commission Testing.
Conformance with cGMP requires that what ever approach is used, it is fully documented in the
individual Validation (Master) Plan (VMP or VP). The IQ should not start with the FAT or
Commissioning tasks, but it should start before these tasks are completed; enabling the validation
team to witness and document the final FAT and commissioning testing. The integration of these
activities greatly reduces the costly and time consuming replication of unnecessary retesting.
SB2.1. INSTALLATION QUALIFICATION (IQ) CHECKLIST FOR COATING
SYSTEM:
The objective of the coating system IQ is to establish documented evidence that the
equipment is acceptable based on Master Manufacturing Instruction (MMI), process
requirement, and the engineers standard and precepts. In preparing IQ checklist, consideration
must be given to the aspects such as equipment identification, required documentation,
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equipment utility requirement, major equipment component specifications, component materials,
safety features, etc. IQ checklist for coating system would, therefore, cover the following:
i) Verification of identification information.

ii) Verification of required documentation.
iii) Verification of all components and availability of parts.
iv) Verification of installation location that it meets Good Manufacturing Practice (GMP)
requirements
v) Verification of power supply requirements that should comply with GMP.
vi) Verification of safety features that should be tested, e.g. alarms and visual displays,
etc.
SB2.2. INFORMATION/ DOCUMENTS INCLUDED IN THE COATING SYSTEM
FILE:
Information/ documents that would be included in the coating system file comprise the
following:
i) Equipment ID, e.g. model and serial number.
ii) Major components of equipment and their specification including specification for
material of construction.
iii) All manuals, drawing relevant outputs from the instrument, and certificates of
conformity.
iv) Standard Operating Procedure (SOP) of each equipment used in the coating system.
v) Certificate of calibration of each equipment.
vi) Utilities to be used.
vii) Safety features.
viii) Process of coating.
ix) Tablet defect specifications.
x) Film coating features, i.e. weight gain, appearance, etc.
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xi) Film coating material, i.e. film former, plasticizer, solvent, colorant, etc.
xii) All GMP aspects.
xiii) All personal safety considerations, etc.
SB3. CONCLUSION:
Qualification ensures compatibility of individual phases of a procedure, process or
activity with specifications, which determines readiness for use. IQ is relevant to the documented
verification that all aspects of hardware installation adhere to appropriate codes and approved
design intentions, and that the recommendations of the manufacturer have suitably been
considered. In short, IQ establishes confidence that equipment is properly installed. IQ is,
therefore, necessary for consistent production of a product meeting its predetermined
specifications and quality. The IQ checklist for coating system and information about documents
that should be integrated in the coating system file are presented in the current studied project,
which will be helpful to fulfill the intention.
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SECTION C
FLOW CHART OF OPERATIONAL QUALIFICATION (OQ)
FOR THE COATING SYSTEM
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SC1. INTRODUCTION:18
SC1.1. OPERATIONAL QUALIFICATION (OQ):
Operational Qualification (OQ) establishes that the equipment can operate within
specified tolerances and limits. It calls for:
 Calibration requirements,
 The equipment control functions (switches, etc.), and
 Equipment operation (rotation speed, direction, etc.) ability, not quality or not product
dependent.
SC2. FLOWCHART OF OPERATIONAL QUALIFICATION (OQ) FOR THE
COATING SYSTEM:
The flowchart of OQ for the coating system is presented in Figure 2.
SC3. CONCLUSION:
In order to operate the equipment within specified tolerances and limits, OQ is required
to be established. The flowchart of OQ for the coating system presented in the current studied
project will, therefore, be helpful to fulfill the purpose.
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AUTOMATIC
AUTOMATIC AIR
AIR COATING
COATING INLET
INLET AIR
AIR
COMPRESSOR
COMPRESSOR PAN
PAN HEPA
HEPA SYSTEM
SYSTEM
On/off
On/off switch
switch Power
Power cord
cord Power
Power cord
cord
On/off
On/off switch
switch
Power cord
Speed
Speed regulator
regulator Heat
Heat control
control switch
switch
Automatic control
pressure device
Automatic control On/off
On/off switch
switch
pressure device
COATING PROCESS
Motor
Baffles
Baffles Hot
Hot air
air inlet
inlet pipe
pipe
Shutter
Shutter
Valve for air supply
Air quality Nozzle Lever

Log books Filter
Spray bottle Nozzle cap
Light
Equipment unplug Contaminant air pipe

Spray adjustment knob
Exhaust control
RH and temperature knob
Coating solution pipe
Room status
Differential pressure
switch Power cord
Trigger Compress air supply house
COATING SPRAY OUTLET AIR

STATION (ROOM) GUN HEPA SYSTEM
Figure 2: Flowchart of Operational Qualification (OQ) for the coating system.
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REFERENCES:
[1] “Introduction to Pharmaceutical Coating”. TIPT Hand Notes, Toronto Institute of
Pharmaceutical Technology 2013–2014, pp. 2–27.
[2] Parmar, K.D.; Bhatt, N.M.; Pathak, N.L.; Patel, L.D.; Kela, A.N.; Nathani, H.S. and
Chauhan, V.V. An overview: Aqueous film coating technology on tablets. International
Journal of Pharmaceutical and Chemical Sciences 2012, 1, pp. 645–652.
[3] Shah, A. Film coating technology: An overview. PHARMAINFO.NET
(http://www.pharmainfo.net/reviews/film-coating-technology-overview).
[4] Cole, G. Pharmaceutical Coating Technology. Taylor and Francis Ltd. 1998, pp. 1–5.
[5] Hogan J. Pharmaceutical Coating Technology. Taylor and Francis Ltd. 1998, pp. 6–52.
[6] Ankit, G.; Ajay, B.; Kumar, K.M. and Neetu, K. Tablet coating techniques: Concepts and
recent trends. International Journal of Pharmacy 2012, 3, 50–58.
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Pharmaceutical Coating Project

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Pharmaceutical Coating Project

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Page 1 of 27

MD ABUL HAIDER SHIPAR

SA1. INTRODUCTION …………………………………………………………………… 5

SB1. INTRODUCTION ……………………………………………………………………. 15

SC1. INTRODUCTION ……………………………………………………………………. 24

The present studied project is divided into following three sections:

Moreover, incorporation of these variables into a validation project is pointed out.

In this section, process/system qualification and validation are described primarily. An

are also mentioned.

Basic information on Operational Qualification (OQ) is described in this section.

the coating process, can also be obvious from it.

FACTORS AFFECTING THE COATING PROCESS

SA1.1. TABLET COATING:

i) To musk the unpleasant taste, odour or color of the drug,

ii) To provide physical and chemical protection for the drug,

coated multi particulates,

v) To improve the physical elegance by use of special colors,

vi) To assist and facilitate the identification of the drug,

vii) To ease the process of blistering.

release or bioavailability if the drug substance.

SA1.2. TYPES OF TABLET COATING:

i) sealing/water proofing of the tablet cores,

ii) sub coating,

iv) coloring, and

formulation typically comprises polymer, plasticizer, colorants and solvents.

environment of the stomach for one or more of the following reasons:

i) Prevention of acid attack on active constituents unstable at low pH,

experience a sharp, well defined increase in solubility at a specific pH.

mainly used to separate chemically incompatible materials.

SA2. FACTORS INVOLVED IN COATING PROCESS:7–17

There are three primary components involved in tablet coating:

SA2.1. Tablet properties:

SA2.2. Coating process:

production equipment many factors must be well thought-out.

effect (Figure 1).

installations include but are not limited to:

i) Cleanliness of coating station and equipment: The cleanliness of coating station

to big differences in the result.

Figure 1: Schematic diagram of coating machine.

unfavourable effects on the moisture and heat sensitive tablet cores.

content, tensile strength and porosity of the coated tablet.

size needs change in the required flow rate of coating solution.

Moreover, variation in batch size changes the required pan speed.

may introduce variability into the quality of film coated tablets.

SA2.3. Coating composition:

A typical film coating mixture usually composed of the following:

 Solubility in solvent of choice.

recommended levels of plasticizers range from 1% to 50% by weight of film former.

desired usually from 0.01% to 2.0%.

SA3. INCORPORATION OF VARIABLES INTO A VALIDATION PROJECT:

parameters that will enhance the quality of the coating process,

field of pharmacy particularly in formulation development. Process parameters and coating

coated tablets, it is necessary to optimize the parameters.

QUALIFICATION AND VALIDATION IN THE COATING PROCESS

SB1.1. QUALIFICATION AND VALIDATION:18–23

Qualification is a process of assurance that the specific system, premises or equipment

On the other hand, validation is establishing a documented evidence to provide a high

SB1.2. SCOPE AND OBJECTIVE OF QUALIFICATION AND VALIDATION:

intermediate stages of inspections, testing, adapted during manufacturing should be designed

process should be established and provide documented evidence that

design specifications. This constitutes Operational Qualification (OQ).

 A specific process will consistently produce a product meeting its predetermined

specifications and quality attributes. This constitutes Process Qualification (PQ).

qualified and validated.