TOPIC : Qualification of tablet compression (machine) & Capsule filling machine SUBJECT : Validation

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 :
 VALIDATION : Action of proving and documenting that
any process, procedure or method actually and
consistently leads to the expected results.
&
 QUALIFICATION : Action of proving and documenting
that any premises, systems and equipment are properly
installed, and/or work correctly and lead to the expected
results. The term qualification is normally used for
equipment, utilities and systems, and validation for
processes
 In this sense, qualification is part of validation.
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3. TABLET COMPRESSION MACHINE:
 A tablet press is a mechanical device that compresses
powder into tablets of uniform size and weight.
 Tablet Compression Machine is also known as Tablet
Press in Pharmaceutical Industry which is used to make
the tablets according to a pre-determined design.
 Compression is a critical step in the production of a
tablet dosage form. The materials being compressed will
need to have adequate flow and compression properties.
 Factors to be considered during compression are,
 Tooling
 Compression speed
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4. 4

5. TOOLING :
 Tablet compression machines are made in keeping the
view of the type of dies and punches will be used on them,
 The dies and punches and their setup on compression
machine is called tooling.
 The shape ,size and as well as certain identification
markings are determined by compression machine
tooling.
 Each tooling set consist of dies , upper and lower punches.
 Production efficiency, dosage uniformity and appearance
depend upon tooling set.
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6.  Punches :
Length:
Upper punch - 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 :
 DESIGN QUALIFICATION
 INSTALLATION QUALIFICATION
 OPERATIONAL QUALIFICATION
 PERFORMANCE QUALIFICATION
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8. INSTALLATION QUALIFICATION (IQ):
 Verify approved purchase order.
 Check manufacturer and supplier .
 Verify Model number and serial number.
 Check any physical damage.
 Confirm location and installation requirements as per
recommendation of manufacturer .
 Verify that the required utilities are available.
 Installation shall be conducted per instructions provide in
the manual.
OBJECTIVE OF IQ
 To check all the critical contacts parts which directly affect
quality of the product.
 To review proper installation as per checklist.
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9. IQ CHECK LIST:
Compare all specification and write the observation
 Machine height – measure with measuring tape.
 Overall dimension- measure with measuring tape
 Rpm of turret – check by tachometer.
 Hopper :
i)Conventional hopper- by visual check
ii)MOC(master of construction )-using Molybdenum
iii)Height- Measure with measuring tape
 No. of station- visually count no.of holes on turret.
 Type of tooling- using venire caliper check the die hole
diameter .
 Feeder- by visual check.
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Continue…

10.  Required utilities-electricity.
 Thickness controller cam
 Weight of controller cam
 Main drive :
i) ON indicator
ii) Potentiometer
iii) Selector Switch
iv) Emergency switch
 Dust extraction and exhaust system
 Lubrication
i) Oil pressure gauge
ii) Select switch for auto/manual
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By Visual
check

11. OPERATIONAL QUALIFICATION (OQ ):
 Verify alarm control.
 Perform calibration requirements, identify in the
manual or established by the validation team.
 Operate the equipment at low medium and high speed
as per operation manual to verify the operation
control.
 Verify that all switches and push buttons are
functioning properly
 Establish procedures for operation, maintenance and
calibration
 Establish training program for relevant staff Run one
pilot batch for each product
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12.  Objective of OQ :
 To operate machine as per proposed procedure given in
manual and record.
 To challenge the operating parameter of machine and
record.
 To challenge the safety operation and record.
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13. OQ CHECK LIST:
1) Main switch- check visually by operating the main
switch of the machine.
2) Start push button- illuminated green switch By
pressing start button the green switch glows and the main
drive motor should start.
3) stop push button- illuminated red switch By pressing
stop button the red switch glows and the main drive
motor should stop
4) Turret RPM challenge test- set in the digital table
counter by rotating knob check by tachometer Rotation
direction (clockwise ) by visual check
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Continue…

14. OQ CHECK LIST:
5) Emergency switch by visual check .
6)Tablet thickness & Hardness controls : By turning the swing
lever to right/left thickness increased hardness/decrease vise
versa
7) Machine speed adjustment : Release the locking knob and
rotate the hand wheel anticlockwise /clock wise- increased
speed/decreased speed
8) Main upper punch entry: Remove the bolt and rotate the
perforated segment to right/ left-upper punch penetration
increases/ decreases.
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15. PERFORMANCE QUALIFICATION (PQ):
 Its an Evaluation of compression capabilities and tablet
characteristics.
 The compression capabilities and tablet characteristics are:
1) Content uniformity
2) Thickness
3) Hardness
4) Friability
5) weight variation
6) Disintegration test.
should be investigated.
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16. OBJECTIVE OF PQ :
 First three batches of biliary and single layer product to
be compressed on given compression machine.
 All the critical physical parameters of product will be
checked during performance qualification.
 Measure the thickness, hardness, friability and weight
for each triplicate tablet run, as shown below
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17.  CONTENT UNIFORMITY :
- Select 30 tablets randomly from batch
- Assay individually
 ACCEPTANCE CRITERIA:
- Out of 30 tablets 3 tablets can be with in 75 – 125% and
all tablets should be with 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 meet each 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 or equal to 1%, per USP
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19.  WEIGHT VARIATION:
20 - TABLETS
% weight variation= (individual wt-avg wt/ avg wt) x 100
 ACCEPTANCE CRITERIA :
For Average 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 have a variation as large as
shown here.
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20.  DISINTEGRATION TEST :
It is the process of breakdown of tablet into smaller
particles
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TABLETS DISINTEGRATION TIME
Uncoated
Plain Coated
Enteric Coated
Dispersible
Effervescent
Sublingual
Buccal
15 min
60 min
3 hrs
3 min
More than 3 min
4 hrs
4hrs

21. ACCEPTANCE CRITERIA:
 All tablets have disintegrated completely.
 If 1 or 2 tablets fails to disintegrate completely repeat
the test for 12 additional tablets.
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22. VALIDATION/QUALIFICATION OF CAPSULE
FILLING MACHINE
Installation Qualification(IQ)
The Installation Qualification will confirm
details from
 the engineering specifications,
 equipment purchase order
 cGMP guidelines and requirements,
verify that the equipment has been installed
as specified by the vendor
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23. 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 be
checked
 Any deviation observed should be informed to the
supplier or manufacturer
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24.  Details of the Equipment :
 Equipment name, make model no. shall be
recorded
 In-house identification no. shall be recorded
 Location for installation shall be checked
 Utilities required shall be listed down
 A detailed specification must be written which highlight
those parts of machine that are in
product contact
 Where stirring devices or augers are used to ensure
homogeneity and improve flow then specification of
these parts must be checked
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25.  Acceptance Criteria For 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 complete
equipment manual
 Material of construction shall be as per purchase order
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26. Operational Qualification (OQ)
 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
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27. Acceptance criteria For OQ :
 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 alarm/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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28. Performance Qualification(PQ)
 PQ activities demonstrates and documents that the
equipment is able to perform its intended functions
within the variable process limits for a specific product
 Acceptance criteria are developed according to the
regulatory requirements and production parameters
 To ensure that the quality and purity of the
product is maintained
 The PQ will also test the extremes of the operation, or the
peak load conditions, but it does not include testing to
failure.
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29.  Procedure :
 Record the number of damaged capsules
 Capsules from throughout the lot/different batches
should be tested for weight uniformity
 Capsules from throughout the lot/different batches
should be tested for blend content uniformity
 Production speed i.e capsule per minute should be
evaluated
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30. THANK
YOU !
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