Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.

1. TOPIC : Qualification of manufacturing
Equipment
Guided by…
Mrs. Zubala Mirza
(M Pharm)
Presented by…
Mr. Ashish J Hingnekar
Roll no : 03
(B Pharm)
Government College of Pharmacy Amravati 1

2. Qualification
Of
Manufacturing Equipments
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3. Contents …
• Introduction
• Dry Powder Mixer
• Fluidized Bed Dryer
• Capsule Filling Machine
• Tablet Compression machine
• References
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4. QUALIFICATION
INTRODUCTION
 “ It may be defined as the action of providing and documenting that
equipment or ancillary systems are properly installed, work correctly,
and actually lead to the expected results.”
 Qualification is the part of validation.
 Qualification have been grouped into four phases of qualification.
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5. Design
Qualification
(DQ)
Installation
Qualification
(IQ)
Operational
Qualification
(OQ)
Performance
Qualification
(PQ)
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6. DESIGNQUALIFICATION
Design qualification (DQ) defines the functional and operational
Specifications of the instrument.
INSTALLATIONQUALIFICATION
The IQ process is intended to demonstrate that equipment meet all
Specification, installed properly and supporting program (SOP,
Maintenance sheet)are in place.
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7. OPERATIONALQUALIFICATION
OQ is the process of demonstrating that an instrument will function
according to its operational specification in selected environment.
PERFORMANCEQUALIFICATION
It refers to establishing by objective evidence that the process
consistently produces a product which meets all predetermined
requirements.
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8. DRY POWDER MIXER
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9. DRYPOWDERMIXER
Design Qualification (DQ)
 Design qualification (DQ) defines the functional and operational
specifications of the instrument.
Design qualification Of it includes:
 Facility layout,
 Utility requirements
 and specifications.
Required capacity of the Mixer.
Type of materials to be mixed, Mixing time
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10. Installation Qualification (IQ)
The IQ process is intended to demonstrate that the Dry Powder Mixer meet all
specification, installed properly and supporting program (SOP, Maintenance
sheet) are in place.
The IQ includes following checks:
 Supplier or manufacturer name
 address shall be checked
 Equipment name,
 make & model no.
 Check Gear Box,
 Control Panel,
 Buttons,
 Driving Motor
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11. Operational Qualification (OQ)
OQ is the process of demonstrating that an instrument will function
according to its operational specification in selected environment.
OQ includes following checks:
 On/off Switch
 Gross Capacity RPM
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12. Performance Qualification (PQ)
Load the material into the mixer
Start the mixer and rotate it for the time as mentioned in the BMR
After completion of mixing switch off the mixer & Separate out material
Collect the sample as per sampling procedure
Send the samples to QC department for Content Uniformity, Bulk Density &
Sieve analysis
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FLUIDIZED BED DRYER

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FLUIDIZEDBEDDRYER(FBD)
 FBD is used for drying of different pharmaceutical materials or products &
it can easily achieve specific moisture content in granules &powders.
 FBD is able to remove excess moisture from different materials & its
working principle is so precise & focused on drying the materials without
changing their physical attributes.

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Principle
 In fluidization process, hot air is introduced at high pressure through a
perforated bed of moist solid particulate.
 The wet solids are lifted from the bottom & suspended in a stream of air
(fluidized state).
 As the hot air passes between the particles it takes the excess moisture
from the particles thus drying the particles.
Heat transfer is accomplished by direct contact between the wet solid and
hot gases.

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Construction
•There is a removable bowl on the side of the stainless steel fluidized bed dryer & the pressure
chamber is made of stainless steel.
•Air handling units ,product vessels, exhaust filters, exhaust blowers, control panels, air spray
nozzles & solution delivery apparatuses are typical fluidized bed dryer components.
• A suitable pressure drop across the distributor is necessary to ensure proper fluidization.

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Working
Solid powdered material is allowed to flow through an upward stream of air.
This causes all particles to move at a faster rate than their setting rate.
The air will blow up solid particles & suspend them in the air stream as it
passes over them.
Hot air can be used to aid in the fluidization of the bed after it has been
fluidized. Hot air accelerates the drying process.
The air is introduced into the bowl from the bottom & heated to a set
temperature by heaters.
Filtered air is passed through the bed of the material after it has been
filtered . Through the use of a control panel, all parameters of the
equipment, such as flow rate and temperature, can be adjusted

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Steps of Fluidized bed drying

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Fixed
Variable (Monitor)
Response test
• Bowl
• Porosity of filter bags
• Bowl sieve
•Inlet/ exhaust air temperature
•Product temperature
•Drying time
•Air Volume
•Humidity of inlet & exhaust air
• Particle size distribution
• Densities
• Loss on drying
• Assay
Qualification
FBD control Parameters

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DESIGNQUALIFICATION
It involves the functional & operational specification of dryers
Facility layout
• Utility requirement i.e. vertical or horizontal
• Required capacity of the dryer

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INSTALLATIONQUALIFICATION
Procedure:
Check the IQ parameters against their specifications.
Utility Installation, Operating Manual
Check for any physical damage
Verify electrical Supply
Inlet Air installation
SOP, Mfg. / Supplier Details
After checking all the specifications as mentioned in the selection criteria, service
engineer of the manufacturer shall be called for commissioning, if necessary.
Authorized validation team shall carry out installation.
 Department Head of production , QA and engineering department shall evaluate
installation report.

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ACCEPTANCECRITERIAFORINSTALLATIONQUALIFICATION
The equipment shall fulfill the selection criteria & its purpose of
Application.
 Name of the manufacturer & supplier shall be as mentioned in the Purchase
order.
The manufacturer/supplier shall provide complete equipment manual along
with the equipment.

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OPERATIONALQUALIFICATION
Procedure:
Initiate the actual operation of the FBD to ensure that machine is operating
within specification.
Check the OQ parameters against their specifications.
Observe the functioning of all the controls available in the control panel.
Record the observation. Perform and attach the report of Heat Distribution Study
OQ
Parameters
• Check Alarm
control
• Speed of Air
• Moisture content
• Tap Density
• Particle Size
Distribution
• Heat Distribution
study

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ACCEPTANCECRITERIA(HeatDistributionStudy)
 Temperature difference between all thermocouples & set temperature should
not differ by more than 5°C.
All operating inputs provided on the equipment when tested shall
successfully comply /meet tolerance limit.
 The equipment should successfully perform when operated as per SOP.
 Critical gauges/indicators provided on the equipment should be calibrated.

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PERFORMANCEQUALIFICATION
Procedure:
After completion of
OQ initiate the PQ
of FBD.
Run the trial batch
during operation there
should not be change
in the size, shape,
surface
characteristics.
The effectiveness of
drying will be qualified by
determining reduction
of % moisture content in
drying process.
3 batches of any
product will be
taken for PQ of
FBD.
At least 2 gm of sample
is sampled for %
moisture content ;check
from the top, middle &
bottom trays & it will be
reported
In case of any
deviation reported,
inform to department
head for
necessary action.
The reduction in
moisture content after
drying should be as
per the
specification in the
BMR.
% RSD of LOD
should not be
more than 6 %.
The equipment should
produce intended outputs
with respect to
quality & quantity
consistently.

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CAPSULE FILLING MACHINE

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CAPSULEFILLINGMACHINE
Capsule filling machine is a fully
automatic machine with which a
capsule separation, filling and locking
can be done automatically.

28. WorkingStepsinpreparationof Capsule
Rectification
Separation caps from empty capsule size
Filling the bodies
Scraping the excess powder
Replacing the caps
Sealing the capsules
Cleaning the outside of filled Capsule

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INSTALLATIONQUALIFICATION
The installation qualification confirms the details from the
• Engineering specifications
• Equipment purchase order
• cGMP guidelines and requirements
And verify that the equipment has been installed as specified by
the vendor.

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Purchase details :
1. Purchase order no. , Date
2. Accessories and their spare parts
3. Delivery period
4. Supplier or manufacturer name, address
5. Any deviation.

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Details of the Equipment :
1. Equipment name, model no.
2. In- house specifications
3. Location
4. Utilities
5. Detailed specifications
6. Stirring devices or augers to ensure homogeneity.

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ACCEPTANCECRITERIA ( forIQ)
1. Fulfil the selection criteria & it’s purpose
2. Equipment shall be maintained as per purchase order
3. Accessories received
4. Meet pre selected design parameters
5. Manufacturer supplier shall provide equipment operator
manual
6. Material of construction.

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OPERATIONALQUALIFICATION
• Before initiating OQ ensure that SOP for operation & cleaning of
capsule filling machine is available.
• Purpose is to train the qualification team for performing OQ.
Procedure :
1. Check all the dynamic attributes of the filter
2. Initiate the actual operation of equipment to ensure to get the
desired rate of output.
3. Operation of Indicators, controls & alarms
4. Oil leaks.

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ACCEPTANCECRITERIA(forOQ)
1. All operating inputs are provided on the equipment when
tested shall successfully meet tolerance limit.
2. Equipment should successfully perform when operated as
per SOP.
3. Critical alarms of the equipment shall be verified.
4. Should not blow abnormal sound and not having any
discrepancies

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PERFORMANCEQUALIFICATION
Procedure :
• Record the no. of damaged capsules.
• Capsules for uniformity in weight evaluated from different
lot/ batches.
• Content uniformity of capsules.
• Production speed i.e., Capsule per minute should be
evaluated.

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TABLET COMPRESSION MACHINE

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TABLETCOMPRESSIONMACHINE
• Tablets are being formed by compressing the
granules using the compression machine.
• A tablet formation takes place by the combined
pressing action of two punches & dies.

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Principle
 The basic principle behind the tablet compression machine is
hydraulic pressure.
 This pressure is transmitted unreduced through the static fluid.
 Any externally applied pressure is transmitted via static fluid to
all the directions in the same proportion. It also makes it possible to
multiply the force as needed.

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Construction of Tablet compression machine

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Filling
Transfer of granules into
position for compression.
Metering
Removal of excess granules from
the cavity . weight is controlled by
height of lower punch in die which
is controlled by metering cam
Compression
Top & Bottom punch come
together by pressure within die to
form a tablet
Ejection
Removal of tablet from
lower punch die station
Working

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IQ Check list
•Compare all the specifications & write
the obs.
•Machine height
•Overall dimension
•RPM of turret
•Hopper
•Number of station
•Type of tooling
•Required utilities
•Thickness & weight
•Main drive (Potentiometer, Selector
switch, Emergency switch, ON indicator)
•Dust extraction & exhaust system
•Lubrication (select oil pressure guage ,
select switch for auto / manual.)
OQ Check list
•Main switch
•Start push button
•Stop push button
•Turret RPM challenge test( by rotating
the knob, check by tachometer)
•Rotation direction
•Emergency switch by visual check
•Tablet Thickness & Hardness controls
•Machine speed adjustment(Release the
locking knob & rotate the hand wheel
anticlockwise / clockwise – increased
speed / decreased speed)
•Main upper punch entry (remove the bolt
& rotate the perforated segment to right/
left – upper punch penetration increases /
decreases.)

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PERFORMANCE QUALIFICATION
It is an Evaluation of compression capabilities & tablet characteristics. The
compression capabilities & tablet characteristics are :
1. Content uniformity
2. Thickness
3. Hardness
4. Friability
5. Weight variation
6. Disintegration test
All these parameters should be investigated & result should fall under
acceptance criteria.

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References
1. Validation in Pharmaceutical Industry : P.P Sharma.
2. Validation Standard operating procedures : A Syed Imtiaz
Haider
3. Pharmaceutical Process validation : B.T Loftus & R.A Nash

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