The document summarizes the validation process for a tablet compression machine. It discusses the key stages of validation including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ involves verifying that the machine has been installed correctly according to specifications. The OQ tests the operation of the machine's controls and parameters. Finally, the PQ evaluates the machine's compression capabilities by testing the tablets' characteristics such as hardness, thickness, and friability. The document provides details about acceptance criteria for each validation stage.

1. PRESENTED BY : YASH R.MENGHANI
M.PHARM 1st YEAR (SEMISTER II)
SMT.KISHORITAI BHOYAR COLLEGE OF
PHARMACY,KAMPTEE
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2. INTRODUCTION :
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⚫VALIDATION : Action of proving and documenting that
any process, procedureor method actually and
consistently leads to theexpected results.
&
⚫QUALIFICATION : Action of proving and documenting
that any premises, systems and equipment are properly
installed, and/orwork correctlyand lead to theexpected
results. The term qualification is normally used for
equipment, utilities and systems, and validation for
processes
⚫In this sense, qualification is partof validation.

3. TABLET COMPRESSION MACHINE:
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⚫A tabletpress is a mechanical device thatcompresses
powder into tabletsof uniform size and weight.
⚫Tablet Compression Machine is also known as Tablet
Press in Pharmaceutical Industrywhich is used to make
the tabletsaccording toa pre-determined design.
⚫Compression is a critical step in the production of a
tabletdosage form. The materials being compressed will
need to haveadequate flow and compression properties.
⚫Factors to beconsidered during compression are,
 Tooling
 Compressionspeed

4. 4

5. TOOLING :
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⚫Tablet compression machines are made in keeping the
view of the typeof diesand puncheswill be used on them,
⚫Thedies and punchesand theirsetupon compression
machine is called tooling.
⚫The shape ,size and as well as certain identification
markings are determined by compression machine
tooling.
⚫Each tooling setconsistof dies , upperand lowerpunches.
⚫Productionefficiency, dosage uniformityand appearance
depend upon tooling set.

6. ⚫Punches :
Length:
Upperpunch - 5.25 inches
Lower punch - 3 inches.
Barrel diameter- 0.75 inches.
Head diameter- 1 inch
⚫D tooling : Is popular for large tablets
Punch:
Length- 5.25 inch
Head diameter- 1.25 inch
Barrel diameter- 1 inch
Dies :
out side diameter – 0.945 inch are used
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7. VALIDATION :
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⚫DESIGN QUALIFICATION
⚫INSTALLATION QUALIFICATION
⚫OPERATIONAL QUALIFICATION
⚫PERFORMANCE QUALIFICATION

8. INSTALLATION QUALIFICATION (IQ):
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⚫Verifyapproved purchaseorder.
⚫Check manufacturerand supplier .
⚫Verify Model numberand serial number.
⚫Check any physical damage.
⚫Confirm location and installation requirementsas per
recommendation of manufacturer .
⚫Verify that the required utilitiesareavailable.
⚫Installation shall be conducted per instructions provide in
the manual.
OBJECTIVE OF IQ
⚫Tocheck all thecritical contacts parts which directlyaffect
qualityof the product.
⚫To review proper installation as perchecklist.

9. IQ CHECK LIST:
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Compareall specification and write theobservation
⚫Machine height – measurewith measuring tape.
⚫Overall dimension- measurewith measuring tape
⚫Rpm of turret – check by tachometer.
⚫Hopper :
i)Conventional hopper- by visual check
ii)MOC(masterof construction )-using Molybdenum
iii)Height- Measurewith measuring tape
⚫No. of station- visuallycount no.of holes on turret.
⚫Typeof tooling- using venire calipercheck thedie hole
diameter .
⚫Feeder- byvisual check.
Continue…

10. ⚫Required utilities-electricity.
⚫Thickness controllercam
⚫Weightof controllercam
⚫Main drive :
i) ON indicator
ii) Potentiometer
iii) SelectorSwitch
iv) Emergency switch
⚫Dustextraction and exhaustsystem
⚫Lubrication
i) Oil pressuregauge
ii) Selectswitch forauto/manual
By Visual
check
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11. OPERATIONAL QUALIFICATION (OQ ):
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⚫Verify alarm control.
⚫Perform calibration requirements, identify in the
manual orestablished by thevalidation team.
⚫Operate theequipmentat low mediumand high speed
as per operation manual to verify the operation
control.
⚫Verify thatall switchesand push buttonsare
functioning properly
⚫Establish procedures foroperation, maintenanceand
calibration
⚫Establish training program forrelevantstaff Runone
pilot batch foreach product

12. ⚫Objectiveof OQ :
⚫Tooperate machineas per proposed proceduregiven in
manual and record.
⚫Tochallenge theoperating parameterof machineand
record.
⚫Tochallenge the safetyoperation and record.
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13. OQ CHECK LIST:
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1)Main switch- check visually byoperating the main
switchof the machine.
2)Start push button- illuminated green switch By
pressing start button thegreen switchglowsand the main
drive motorshould start.
3)stoppush button- illuminated red switch By pressing
stop button the red switch glows and the main drive
motorshould stop
4)Turret RPM challenge test- set in the digital table
counterby rotating knobcheck by tachometer Rotation
direction (clockwise ) byvisual check
Continue…

14. OQ CHECK LIST:
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5) Emergency switch byvisual check .
6)Tablet thickness & Hardness controls : By turning the swing
lever to right/left thickness increased hardness/decrease vise
versa
7)Machinespeed adjustment : Release the locking knob and
rotate the hand wheel anticlockwise /clock wise- increased
speed/decreased speed
8)Main upperpunch entry: Remove the bolt and rotate the
perforated segment to right/ left-upper punch penetration
increases/ decreases.

15. PERFORMANCE QUALIFICATION (PQ):
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⚫Its an Evaluation of compression capabilitiesand tablet
characteristics.
⚫Thecompression capabilitiesand tabletcharacteristics are:
1) Content uniformity
2) Thickness
3) Hardness
4) Friability
5) weightvariation
6) Disintegration test.
should be investigated.

16. OBJECTIVE OF PQ :
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⚫First three batchesof biliary and single layerproduct to
becompressed on given compression machine.
⚫All thecritical physical parameters of productwill be
checked during performance qualification.
⚫Measure the thickness, hardness, friabilityand weight
foreach triplicate tabletrun, as shown below

17. ⚫CONTENT UNIFORMITY :
- Select 30 tablets randomly from batch
- Assay individually
⚫ACCEPTANCE CRITERIA:
- Outof 30 tablets 3 tabletscan be with in 75 – 125% and
all tablets should bewith in 85 -115%
⚫THICKNESS :
- First 20, last 20, middle 20 tablets (throughout the run)
Determine mean and standard deviation.
⚫ACCEPTANCE CRITERIA:
- The Relative Standard Deviation should be less than or
equal to 5%
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18. ⚫HARDNESS :
- First 20, last 20, middle 20 tablets (throughout the run)
Determine mean and standard deviation for baseline
⚫ACCEPTANCE CRITERIA :
-Must meeteach tablet specifications.
Chewable tablets- 3kg/cm2
Tablets- 4-8kg/cm 2
sustained release tablets & troches- 10-20kg/cm 2
⚫FRIABILITY:
- First 20, last 20, middle 20 tablets
% friability =( initial wt - final wt / initial wt )
⚫ACCEPTANCE CRITERIA:
- Weight loss less than orequal to 1%, per USP
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19. ⚫WEIGHTVARIATION:
20 - TABLETS
% weightvariation= (individual wt-avg wt/ avg wt) x 100
⚫ACCEPTANCE CRITERIA :
ForAverage Weight 130 mg or less 10% difference For
Average Weight 130 to 324 mg 7.5% difference For
Average Weight More than 324 mg 5% difference
Not more than two tablets haveavariationas largeas
shown here.
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20. ⚫DISINTEGRATION TEST :
It is the processof breakdownof tablet into smaller
particles
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TABLETS DISINTEGRATION TIME
Uncoated 15 min
Plain Coated 60 min
Enteric Coated 3 hrs
Dispersible 3 min
Effervescent More than 3 min
Sublingual 4 hrs
Buccal 4hrs

21. ACCEPTANCE CRITERIA:
⚫All tablets havedisintegrated completely.
⚫If 1 or 2 tablets fails todisintegratecompletelyrepeat
the test for 12 additional tablets.
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22. VALIDATION/QUALIFICATION OF CAPSULE
FILLING MACHINE
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Installation Qualification(IQ)
The Installation Qualification will confirm
details from
⚫theengineering specifications,
⚫equipment purchaseorder
⚫cGMP guidelines and requirements,
verify that theequipment has been installed
as specified by thevendor

23. Purchase Details :
⚫The purchaseorder no. date shall be checked
⚫The accessories theirspare parts if any shall
bechecked as perpurchaseorder
⚫Thedelivery period shall beas perpurchase
order
⚫Supplieror manufacturer nameaddress shall be
checked
⚫Anydeviation observed should be informed to the
supplieror manufacturer
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24. ⚫Detailsof the Equipment :
⚫Equipment name, make model no. shall be
recorded
⚫In-house identification no. shall be recorded
⚫Location for installationshall be checked
⚫Utilities required shall be listed down
⚫A detailed specification must bewritten which highlight
thosepartsof machine thatare in
productcontact
⚫Where stirring devicesoraugers are used toensure
homogeneityand improve flow then specification of
these parts must be checked
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25. ⚫Acceptance Criteria ForIQ :
⚫Fulfill the selection criteria its purposeof
Application
⚫Theequipmentshall beas per purchaseorder
⚫Accessories received shall be as perpurchase
order
⚫Should meetpre-selected design parameters
⚫Manufacturer/suppliershall providecomplete
equipment manual
⚫Material of constructionshall beas perpurchaseorder
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26. Operational Qualification (OQ)
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⚫Before initiating OQ ensure that SOP for operation and
Cleaning of Capsule Filling Machine is available.
⚫Purpose is to train the qualification team for
performing OQ
Procedure :
⚫Check all the dynamic attributes of the capsule filler
conform to the required specifications
⚫Initiate the actual operation of the equipment to ensure that
machine is operate within the desired rate of output.
⚫The operation of indicators, controls and alarms is verified
⚫Oil leaks that could contaminate the process are observed

27. Acceptance criteria For OQ :
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⚫All operating inputs provided on theequipment
when tested shall-successfully comply
-meet tolerance limit
⚫Theequipmentshould successfully performwhen
operated as per SOP
⚫Critical alarm/indicators provided on the
equipment-
-calibrated
⚫Theequipmentwhen operated shall not
- produceabnormal sound
- show anydiscrepancy in its smooth
operation.

28. Performance Qualification(PQ)
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⚫PQ activities demonstrates and documents that the
equipment is able to perform its intended functions
within thevariable process limits fora specific product
⚫Acceptance criteria are developed according to the
regulatoryrequirementsand production parameters
⚫To ensure that thequalityand purityof the
product is maintained
⚫The PQ will also test theextremesof theoperation, or the
peak load conditions, but it does not include testing to
failure.

29. ⚫Procedure :
⚫Record the numberof damaged capsules
⚫Capsules from throughoutthe lot/different batches
should be tested forweight uniformity
⚫Capsules from throughout the lot/different batches
should be tested for blend contentuniformity
⚫Production speed i.ecapsuleper minuteshould be
evaluated
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30. THAN
K
YOU !
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