The document discusses validation of a fluidized bed dryer. It describes the purpose of equipment validation and the typical stages: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). For a fluidized bed dryer, IQ involves installing the equipment according to specifications. OQ involves testing that the dryer operates as intended under normal conditions. PQ involves drying product batches and ensuring the dryer reduces moisture content as specified and maintains quality/quantity of output. The document provides details on procedures, acceptance criteria, and revalidation for each qualification stage of the fluidized bed dryer.

1. VALIDATION OF FLUIDIZIED BED DRYER

2. Content:
Why to validate?
Parts of Equipment Validation
Who should do Equipment Validation?
Equipment qualification
Typical process flow of solid dosage form
Validation of fluid bed dryer
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3. Why to validate?
Equipment validation is Vital for
• Safety
• Fewer interruptions of work
• Lower repair costs
• Elimination of premature replacement
• Less standby equipment
• Identification of high maintenance cost
• Reduction of variation in results
• Greater confidence in the reliability of results
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4. Parts of Equipment Validation
Equipment
Validation
Installation
Qualification (IQ)
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Design
Qualification (DQ)
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5. Who should do Equipment Validation?
The vendor or the user?
The user has the ultimate responsibility for
equipment qualification.
DQ should always be done by the user.
While IQ for a small and low cost instrument is
usually done by the user, and
IQ for large, complex and high cost instruments
should be done by the vendor.
OQ can be done by either the user or the vendor.
PQ should always be done by the user
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6. Equipment qualification
Equipment qualification / validation includes
following things :
• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)
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7. Typical process flow of
solid dosage form
Addition of
raw material
-active
excipients
Preble
bending
-high speed
mixer
granulator
Granulating
- high
speed
mixer
granulator
Drying
-fluid bed
dryer
-tray dryer
Tableting
-high speed
rotary
Blending
-v-blender
Addition of
raw material
-lubricant
-disintegrants
Sizing
-mill/sieve
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8. Typical variable of drying process
Control variable
 Initial temperature
Load size
Drying temperature
program
Air flow program
Drying time
Cooling time
Measured responses
Density
Yield
Moisture content
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9. VALIDATION
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10. fluid bed dryer
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11. FBD control parameters
Fixed Variable
(monitor)
Response
(Test)
Bowl change
Porosity of
filter bags
Bowl sieve
Inlet/exhaust air
temperature
Product temperature
Drying time
Air volume
Humidity of incoming air
Humidity of exhaust air
Particle size
distribution
Densities
Loss on drying
Assay
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12. Installation Qualification(IQ)
Installation Procedure:
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 &
engineering shall evaluate installation report
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13. Conti…
Acceptance Criteria For Installation Qualification:
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
All recommended utilities of recommended
capacities are to be provided near the place of
installation
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14. Conti…
Revalidation Criteria
The equipment shall be revalidated if;
Location of the equipment is changed.
There is change of spare/parts,major
maintenance or breakdown that have a direct
effect on the performance of the equipment
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15. Conti…
Conclusion:
The equipment shall be considered qualified for
installation provided it meets all the parameters
mentioned in the acceptance criteria.
After receiving installation report, it shall be
evaluated & released for operational
qualification, provided installation report is
evaluated & the equipment is found meeting all
parameters of acceptance criteria
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16. Operational Qualification (OQ)
Training record
Before initiating OQ ensure that SOP for Cleaning
and operation of FBD is available.
• Purpose: To train the qualification team for
performing OQ
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17. Conti…
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 controls available
on control panel
Record the observation
Perform and attach report of heat distribution
study as per ` Heat distribution study procedure’ 17

18. Conti…
Acceptance criteria (Heat Distribution Study:)
Temperature difference between all
thermocouples and 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
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19. Conti…
Critical gauges/indicators provided on the
equipment---calibrated
The equipment when operated shall not
- produce abnormal sound
- show any discrepancy in its smooth operation.
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20. Conti…
Revalidation Criteria:
The equipment shall be revalidated if;
Location of the equipment is changed.
There is change of spare/ parts, major
maintenance or breakdown that have a direct
effect on the performance of the equipment
Critical gauges shall be replaced or corrected
At normal revalidation schedule.
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21. Performance Qualification(PQ)
To check Heat Distribution by placing 10
thermocouples in geometric pattern with the FBD
Shell and empty Product Container without any
load to ensure heat distribution in the drying
chamber
Heat distribution study will be performed at 65 ±
5°C for two hour after achieving the temperature
on the controlling sensors to ensure proper heat
distribution.
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22. Conti…
Procedure
After completion of OQ initiate the PQ of FBD.
The effectiveness of drying will be qualified by
determining reduction of % moisture content in
drying process.
3 batches/ lots of any product will be taken for PQ
of FBD.
At least 2.0 gm of sample is sampled for % MC
check from the top, middle and bottom trays and
will be reported
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23. Conti…
In case of any deviation inform to department
head for necessary action
Document the deviation details
Deviation is acceptable or not will be decided
-if yes
-if not
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24. Conti…
Acceptance criteria
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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25. Conti…
Revalidation Criteria:
The equipment shall be revalidated if;
Location of the equipment is changed.
There is change of spare/ parts, major
maintenance or breakdown that have a direct
effect on the performance of the equipment
At normal revalidation schedule.
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26. Procedure for Drying Efficacy
Study in Fluidized bed Dryer:
Ensure the cleaning of machine
Load the wet mass in the FBD product container
Set the process time & outlet temperature and
run the FBD.
After completion of drying take out FBD bowl and
collect the sample
At least 2.0 gm of sample is sampled for % MC
check from the top, middle and bottom trays and
will be reported
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27. Conti…
Sampling Procedure:
Ware nose mask, hand gloves before sampling.
Label the sample bag with details as Product
name, stage, date, time and sign
Collect app. 2.0 gms of dried material composite
sample in poly bag as per location shown
Record the details of analysis.
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