Download - Fbd Tray Dryer Validation Maliba
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VALIDATION
OF
FLUID BED AND
TRAY DRYER
A
Seminar
on
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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 Validation of Tray dryer
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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 results3
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PARTS OF EQUIPMENT VALIDATION
Equipment
Validation
Installation
Qualification (IQ)
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Design
Qualification (DQ)
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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 isusually 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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EQUIPMENT QUALIFICATION
Equipment qualification / validation includes
following things :
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
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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 ofraw material
-lubricant
-disintegrants
Sizing
-mill/sieve
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TYPICAL VARIABLE OF DRYING PROCESS
Control variable
Initial temperature
Load size
Drying temperature
program
Air flow programDrying time
Cooling time
Measured responses
Density
Yield
Moisture content
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VALIDATION
OFFLUID BED DRYER
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FLUID BED DRYER
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FBD CONTROL PARAMETERS
Fixed Variable
(monitor)
Response
(Test)
Bowl change
Porosity offilter bags
Bowl sieve
Inlet/exhaust air
temperatureProduct temperature
Drying time
Air volume
Humidity of incoming airHumidity of exhaust air
Particle size
distributionDensities
Loss on drying
Assay
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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, ifnecessary.
Authorized validation team shall carry out
installation. Department Head of production, QA &
engineering shall evaluate installation report
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Conti
Acceptance Criteria For Installation Qualification: The equipment shall fulfill the selection criteria & its
purpose of Application.
Name of the manufacturer & supplier shall be asmentioned 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
installation13
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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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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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OPERATIONAL QUALIFICATION (OQ) Training record
Before initiating OQ ensure that SOPfor
Cleaning and operation of FBD is available.
Purpose:To train the qualification team forperforming OQ
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Conti Procedure Initiate the actual operation of the FBD to ensure
that machine is operating within specification.
Check the OQ parameters against theirspecifications.
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
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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 SOP18
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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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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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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 dryingchamber
Heat distribution study will be performed at 65
5C for two hour after achieving the temperature
on the controlling sensors to ensure proper heat
distribution.
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Conti Procedure
After completion of OQ initiate the PQ of FBD.
The effectiveness of drying will be qualified by
determining reduction of % moisture content indrying 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 andwill be reported
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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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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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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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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 % MCcheck from the top, middle and bottom trays and
will be reported
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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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Validation
of
Tray dryer
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TRAY DRYER
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TRAY DRYER CONTROL PARAMETERS
Fixed Variable
(monitor)
Response
(Test)
Trays Inlet/exhaust air
temperatureProduct temperature
Drying time
Air volume
Humidity of incoming airHumidity of exhaust air
Particle size
distributionDensities
Loss on drying
Assay
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INSTALLATION QUALIFICATION(IQ) Procedure:
Selection criteria shall be defined and based on
specific function to be carried out by the machine
& its efficiency.
Requirement of accessories shall be decided &
listed out.
Supplier or manufacturer selection
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Conti Purchase Details:
The purchase order no. & date shall be checked
The accessories & their spare parts if any shall be
checked as per purchase order
The delivery period shall be as per purchase order
Supplier or manufacturer name & address shall bechecked
Any deviation observed should be informed to the
supplier or manufacturer32
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Conti Details of the Equipment
Equipment name, make & model no. shall be
noted down
In-house identification no. shall be allocated
Location for installation shall be decided
Utilities required shall be listed down
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Conti 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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Conti Acceptance CriteriaFor IQ Fulfill the selection criteria & its purpose of
Application
The equipment shall be as per purchase order Accessories received shall be as per purchase order
Should meet pre-selected design parameters
Manufacturer/supplier shall provide completeequipment manual
Material of construction shall be as per purchaseorder
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OPERATIONAL QUALIFICATION (OQ) Training record
Before initiating OQ ensure that SOPfor
Cleaning and operation of Tray dryer is available.
Purpose:To train the qualification team forperforming OQ
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Conti Procedure
Initiate the actual operation of the TD 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
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Conti Acceptance criteria
All operating inputs provided on the equipment whentested shall-successfully comply
-meet tolerance limit
The equipment should successfully perform whenoperated as per SOP
Critical gauges/indicators provided on the equipment-
--calibrated The equipment when operated shall not
- produce abnormal sound
-show any discrepancy in its smooth operation.38
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PERFORMANCE QUALIFICATION(PQ) To check Heat Distribution by placing 10
thermocouples in geometric pattern with the TD
Shell and empty Product Container without any
load to ensure heat distribution in the dryingchamber
Heat distribution study will be performed at +45
C and +105C for one hour after achieving thetemperature on the controlling sensors to ensure
proper heat distribution.
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Conti Procedure
After completion of OQ initiate the PQ of TD
The effectiveness of drying will be qualified by
determining reduction of % moisture content indrying process.
3 batches/ lots of any product will be taken for
PQ of TD At least 2.0 gm of sample is sampled for % MC
check from the top, middle and bottom trays andwill be reported
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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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Conti Acceptance criteria Temperature difference between all thermocouples
and set temperature should not differ by more than
5 C. 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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REFERENCES
Berry I.R., and Nash R.A., Pharmaceutical
Process validation second edition, revised and
expanded; Marcel Dekker series; 83-110.
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SEMINAR OPEN FOR DISCUSSION
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