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Validation of dry_powder_mixer_ .
1. A seminar onA seminar on
Validation & Qualification ofValidation & Qualification of
Dry Powder Mixers, FluidDry Powder Mixers, Fluid
Bed Dryer,Tray DryerBed Dryer,Tray Dryer
By
ADITI ROY
MPH/10026/18
M.Pharm. (Sem - II)
Dept. of Pharmaceutical sciences &Technology
BIRLA INSTITUTE OFTECHNOLOGY
MESRA, RANCHI
1
2. ContentsContents
ī Introduction
ī Need of validation
ī Powder mixers validation
ī Validation of FBD
ī FBD control parameters
ī Validation of Tray dryer
ī Tray dryer control parameters
ī Acceptance criteria
ī References
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3. Why to validate?Why to validate?
Equipment validation is Vital for-
âĸ Safety.
âĸ Fewer interruptions of work.
âĸ Lower repair costs.
âĸ Elimination of premature replacement.
âĸ Less standby equipment.
âĸ Identification of high maintenance cost.
âĸ Reduction of variation in results.
âĸ Greater confidence in the reliability of results.
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6. IntroductionIntroduction
ī Validation of Dry Powder
Mixers
It is defined as documented act
which provide the high degree of
the assurance that Powder Mixer
equipment actually leads to the
desired mixing or blending.
ī§ Why it is essential ?
The mixing of the API and
excipients is the critical step in
the solid dosage form
preparations that affect the
content uniformity at great extent.
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7. Types of the powder blendersTypes of the powder blenders
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V cone blenders
Double cone blenders
Drum mixer
Conical screw mixer
Ribbon blenders
Tumble blender
9. Installation Qualification (IQ)Installation Qualification (IQ)
Details of the Equipment
ī Equipment name, made by & model No. shall be noted down.
ī Location for the installation equipment shall be checked.
ī Utilities required shall be listed down.
ī Any deviation observed while following above procedure
should be informed for corrective action.
Installation Procedure:
ī After checking all the specifications as mentioned in the
selection criteria, service engineer shall commission the
equipment.
ī Authorized validation team shall carry out installation checks.
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10. Operational Qualification(OQ)Operational Qualification(OQ)
īAfter completions of successful installation qualification
initiate the actual operation of to ensure that machine is
operating within specification.
īCheck the operation qualification parameters against
their specifications.
īDocument the deviation details.
īThe Quality head and the department head shall decide
whether deviation is acceptable or not.
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11. Performance Qualification (PQ)Performance Qualification (PQ)
īLoad the materials to be mixed in the mixer.
īStart the mixer and rotate it for the time as mentioned in
the BMR.
īAfter completion of mixing switch OFF the mixer and
separate out the drum.
īCollect the sample as per sampling procedure.
īSend the samples to Quality control dept. for content
uniformity, bulk density and sieve analysis.
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12. Revalidation CriteriaRevalidation Criteria
īLocation of the equipment is changed.
īThere is change of spare/ parts that have a
direct effect on the performance of the
equipment.
īAt normal revalidation schedule.
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14. FBD control parametersFBD control parameters
Fixed Variable
(Monitor)
Response
(Test)
īBowl change
īPorosity of filter
bags
īBowl sieve
īInlet/exhaust air
temperature
īProduct
temperature
īDrying time
īAir volume
īHumidity of
incoming air
īHumidity of
exhaust air
īParticle size
distribution
īDensities
īLoss on drying
īAssay
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16. Installation Qualification(IQ)Installation Qualification(IQ)
16
īąInstallation Procedure:
īAfter checking all the specifications as
mentioned in the selection criteria, service
engineer of the manufacturer shall be called for
commissioning, if necessary.
īAuthorized validation team shall carry out
installation.
īDepartment Head of production, QA &
engineering shall evaluate installation report.
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17. ContiâĻContiâĻ
īą Acceptance Criteria For Installation
Qualification:
īThe equipment shall fulfill the selection criteria
& its purpose of Application.
īName of the manufacturer & supplier shall be
as mentioned in the Purchase order.
īThe manufacturer/supplier shall provide
complete equipment manual along with the
equipment.
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18. Operational Qualification (OQ)Operational Qualification (OQ)
īą Procedure
ī Initiate the actual operation of the FBD to ensure that
machine is operating within specification.
ī Check the OQ parameters against their specifications.
ī Observe the functioning of all controls available on
control panel.
ī Record the observation.
ī Perform and attach report of heat distribution study as
per ` Heat distribution study procedureâ.
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19. ContiâĻContiâĻ
īą Acceptance criteria (Heat Distribution Study:)
ī Temperature difference between all thermocouples and
set temperature should not differ by more than ¹ 5 °C.
ī All operating inputs provided on the equipment when
tested shall-successfully comply meet tolerance limit.
ī The equipment should successfully perform when
operated as per SOP.
ī Critical gauges/indicators provided on the equipment-
calibrated.
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20. Performance Qualification(PQ)Performance Qualification(PQ)
īą Procedure
ī After completion of OQ initiate the PQ of FBD.
ī The effectiveness of drying will be qualified by
determining reduction of % moisture content in drying
process.
ī 3 batches/ lots of any product will be taken for PQ of
FBD.
ī At least 2.0 gm of sample is sampled for % MC check
from the top, middle and bottom trays and will be
reported.
ī In case of any deviation inform to department head for
necessary action.
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21. ContiâĻContiâĻ
īDocument the deviation details
īąAcceptance criteria
īThe reduction in moisture content after drying
should be as per the specification in the BMR.
ī % RSD of LOD should not be more than 6 %.
īThe equipment should produce intended
outputs with respect to quality & quantity
consistently.
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23. Tray Dryer control parametersTray Dryer control parameters
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Fixed Variable
(monitor)
Response
(test)
Trays īInlet/exhaust air
temperature
īProduct
temperature
īDrying time
īAir volume
īHumidity of
incoming air
īHumidity of
exhaust air
īParticle size
distribution
īDensities
īLoss on drying
īAssay
25. Installation Qualification(IQ)Installation Qualification(IQ)
īą Procedure:
ī Selection criteria shall be defined and based on specific
function to be carried out by the machine & its
efficiency.
ī Requirement of accessories shall be decided & listed
out.
Details of the Equipment
ī Equipment name, make & model no. shall be noted
down.
ī In-house identification no. shall be allocated.
ī Location for installation shall be decided
ī Utilities required shall be listed down.
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26. Operational Qualification (OQ)Operational Qualification (OQ)
īąProcedure
īInitiate the actual operation of the TD to
ensure that machine is operating within
specification.
īCheck the OQ parameters against their
specifications.
īObserve the functioning of all controls
available on control panel.
īRecord the observation.
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27. Acceptance criteria-Acceptance criteria-
ī operating inputs provided on the equipment when
tested shall-successfully comply
-meet tolerance limit.
ī The equipment should successfully perform when
operated as per SOP.
ī Critical gauges/indicators provided on the equipment-
--calibrated.
ī The equipment when operated shall not
- produce abnormal sound
- show any discrepancy in its smooth operation.
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28. Performance Qualification(PQ)Performance Qualification(PQ)
īTo 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
drying chamber.
īHeat distribution study will be performed at
+45 °C and +105°C for one hour after
achieving the temperature on the controlling
sensors to ensure proper heat distribution.
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29. ContiâĻContiâĻ
īąProcedure
īAfter completion of OQ initiate the PQ of TD.
īThe effectiveness of drying will be qualified by
determining reduction of % moisture content in
drying process.
ī3 batches/ lots of any product will be taken for
PQ of TD.
īAt 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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30. ContiâĻContiâĻ
īąAcceptance criteria
īTemperature difference between all
thermocouples and set temperature should not
differ by more than ¹ 5 °C.
īThe reduction in moisture content after drying
should be as per the specification in the BMR.
ī % RSD of LOD should not be more than 6 %.
īThe equipment should produce intended
outputs with respect to quality & quantity
consistently.
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31. BibliographyBibliography
ī http://www.validationonline.net/Mixer.html
(last accessed on 13.09.2018)
ī www.askaboutvalidation.com
(last accessed on 10.03.2019)
ī Sayed Imtiyaz Haider, âpharmaceutical master validation
planâ, published by st. Luice press, vol-1 page no 125.
ī Jozef H.Timmermans ,âA Report of the Product Quality
Research Institute Workshop on Blend Uniformityâ
IJPSR, page-3 .
ī Berry I.R., and Nash R.A., âPharmaceutical Process
validationâ second edition, revised and expanded;
Marcel Dekker series; 83-110.
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