The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.

1. QUALIFICATION OF TABLET COMPRESSION
MACHINE
Prepared By,
Mr. Pritam P. Kolge
M.Pharm First Year (SemII)
Department of Pharmaceutical Quality
Assurance
Bharati Vidyapeeth College of Pharmacy,
Kolhapur
6/29/2020
1
Guided By,
Dr. Mrs. N.M.Bhatia
Professor and Head,
Department of Pharmaceutical Quality
Assurance

2. CONTENT
Introduction
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Case Study
Conclusion
Reference
6/29/2020
2

3. INTRODUCTION
6/29/2020
3
Qualification an ideal step for equipment validation is the action undertaken to demonstrate
the intended use and performance of the utilities and equipment. The individual steps of
qualification such as design, installation, operational and performance qualification were
done in order to qualify the equipment. Blue print of equipment validation was also
included. The compression parameters such as compression force, turret rpm and feeder
rpm were studied. The process capability of the equipment was studied by observing the
weight of 20 tablets, disintegration time, friability, individual weight variation, thickness
and hardness. These parameters were studied at three different speeds and the best results
were obtained at the optimum speed (40 rpm).

4. Design Qualification
 Providing documented evidence that the design of the facility and equipment meet
the requirements of the user specification and GMP.
 The purpose of the Design Qualification (DQ) is to define the functional
specifications of the system and document the vendor selection process.
 Documentation and verification of procedures required to fulfill the protocol.
 Execution of protocol and data collection, interpretation and review of data for
accuracy, completeness and cGMP compliance.
 Approval of original protocol formats, approval for the final summaries and
system qualification statement.
6/29/2020
4

5. Installation Qualification (IQ):
 The information required for an IQ evaluation is
• Equipment identification,
• Required documentation,
• Equipment utility requirements,
• Major component specifications,
• Component material,
• Lubricants and equipment safety features.
6/29/2020
5

6.  Equipment Identification:
Record the equipment identification numbers, along with the following information:
▪ Model number
▪ Serial number
▪ Company assigned equipment number and
▪ Location of the equipment
 Required Documentation:
Record the equipment manufacturer's operation and maintenance manual and
drawings. Record the SOP that cover the setup, operation and cleaning of the tablet
press.
 Equipment Utility Requirements:
Compare the manufacturer's specified volts (V) and amps (A) requirements to their
conditions at the time of qualification testing and record. Also record the location of the
power supply source.
6/29/2020
6

7.  Major Component Specifications:
The component specifications section of the protocol verifies that the tablet
press components purchased were delivered and installed.
 Component material:
Record the material of each component that contacts the product.
 Lubricants:
Record the lubricants used to operate the tablet press and indicate if they
make contact with the product.
 Equipment Safety Features:
The objective of testing equipment safety features is to verify that the safety
features on the tablet press function according to the manufacturer's specifications.
This test is performed with the tablet press empty. Verify that all of the guards are
present and record the results.
6/29/2020
7

8. Operational Qualification (OQ):
 An OQ evaluation should establish that the equipment can operate within specified tolerances
and limits. The mechanical ranges of the tablet press are challenged, along with the basic tablet
press operations. The tablet press will be validated for its operating ability. Information required
for the OQ evaluation is:
• calibration of the instruments used to control the tablet press
• equipment control functions (switches and push buttons)
• equipment operation (cam tracks, upper punches, lower punches, feed frames, take off bars,
rotor head direction, tablet press speed).
 Calibration requirements
Verify that all the critical instruments on the equipment have been logged into the calibration
system, have calibration procedures in place and are in calibration at the time of qualification
testing. Record all information for calibrated instruments used to control the tablet press.
 Equipment Control Functions
The objective of testing equipment control functions is to verify that the switches and push
buttons on the tablet press operate per the manufacturer's specifications. The tests will be
performed with the tablet press empty. Operate each control and verify its proper position.
6/29/2020
8

9.  Equipment Operation:
 A) Cam Tracks Test
The objective of the cam track test is to verify that the upper and lower cam tracks make
contact with the upper punches according to the manufacturer's specification.
• Install the punches and verify that the cams are contacting the punch head angles on the
both the sides of the double-sided cams.
 B) Upper Punch Test
The objective of the upper punch test is to verify that the upper punch penetration is
according to the manufacturer's specification. A vernier caliper is required for this test,
which is performed as follows:
• Attach a piece of tape to mark the depth of penetration of an upper punch when it is set
to a standard depth.
• Remove the upper punch and use a calibrated vernier caliper to measure the depth of
penetration into the die. Record the results and instrument used to measure the depth.
6/29/2020
9

10.  C) Lower Punch Test
The objective of the lower punch test is to verify that the lower punch height is set
according to the manufacturer's specification. A dial indicator test is required. Measure the
height of the lower punch above the die with a dial indicator and record the results and the
instrument used to measure the height.
 D) Take Off Bar Test
The objective of the take-off bar test is to verify that the take-off bars do not make
contact with the lower punches. Turn the tablet press by hand and verify that the takeoff
bars do not make contact with the lower punches. Record the results.
 E) Feed Frame Test
The objective of the feed frame test is to verify that the feed frame distance above
the rotor head is according to the manufacturer's specification. Feeler gauge test: Measure
the clearance between the feed frame and the motor head with a feeler gauge and record
the results and the instrument used to measure the clearance.
6/29/2020
10

11.  F) Tablet Press Rotation Direction
The objective of the rotation direction test is to verify that the rotor head
rotates in the proper direction. The tests will be performed with the tablet press
empty. Press the start switch and observe the direction of the rotation of the rotor
head as viewed from front of the press and record the results.
 G) Tablet Press Speed
The objective of the speed test is to verify that the measured speeds are
within ± 10 % of the manufacturer's specification of a minimum of 9 rpm and a
maximum of 36 rpm. This test will be performed with the press empty. A stop
watch is required for this test. Measure the speed of the rotor head with a
calibrated stopwatch. Verify that the measured speeds are within ± 10 % of the
manufacturer's specification and record the results and the instrument used to
measure the speed.
6/29/2020
11

12. 6/29/2020
12
Take off Bar Feed Frame
Dial Indicator
Feeler Gauge

13. Performance Qualification:
6/29/2020
13
 The blend/dummy material is unloaded into the hoppers on the both sides and the
compression machine is operated at low speed (20RPM) as per operating instructions.
Then the machine is set to run for 20 minutes continuously after adjusting the following
parameters.
1. Individual tablet weight variation
2. Weight of 20 tablets
3. Hardness
4. Thickness
5. Disintegration time
6. Friability

14. 6/29/2020
14
 Then the experiment was repeated at both medium (40RPM) and high speed (60RPM)
with same set of parameters and the parameters were checked at different speeds (low,
medium and high rpm).
 Sampling Plan
Collect 100 tablets for every 05 minutes.

15. Case Study- sticking issues in tablet production
 The problem
The Italian division of Novartis approached I Holland Company and local agent Vis Viva with
a sticking issue on an antiepileptic drug in the form of a coated tablet.
Novartis reported a strong sticking/picking problem causing the press to be stopped several
times during manufacture for cleaning and maintenance of the punches, which resulted in
production downtime. Sticking and picking halted production
These two problems can be caused by various factors related to the physicochemical properties
of the formulation components, the surface characteristics of punch face, as well as factors related
to the machinery and the environment, for example, compression force and speed, temperature
and humidity.
It has a negative effect on tablet appearance and often results in the removal of tablet tooling
from production for regular cleaning and maintenance, as experienced by Novartis.
6/29/2020
15

16. 6/29/2020
16
Picking was another problem encountered by the company — this is when compressed
granule that has adhered to the detail on the punch face, results in ‘picking out’ of parts
from the tablet face.

17.  The Solution
The selected anti-stick coating was used on the punches and applied to the tooling
by using an electron beam process. This is one of the smoothest and most defect-free
methods of applying a PVD coating as it does not create droplets during the
atomization process. The atomic particles are attracted to the tooling leaving an even
surface which is far less susceptible to breakaway defects.
From the first trial of the new design and tooling using PharmaCote CN+,
improvements were seen and all sticking/picking issues were instantly resolved
resulting in a 25% increase in production. This was achieved over a five-day
working week, with reduced hours, resulting in a full day’s production time saved.
Before the implementation of the new tablet design and tool coating, four batches of
the tablet were produced during a 6-day working week. This included the extra time
required for cleaning and maintenance due to the original sticking/picking problem.
Once I Holland’s improvements were adopted, a further batch was produced in the
same time-period with a total of five batches manufactured without the need to stop
production.
As a result of this outcome, Novartis is now looking at further products to be
analyzed to improve production and reduce down-time. 6/29/2020
17

18. CONCLUSION
 The parameters studied under the compression process are such as compression
force, turret rpm and feeder rpm. These are set at three different speeds and
analyzed on both sides to assess the exact parameters.
 The samples were collected from both the sides (LHS, RHS) to qualify the two
press stations and the observations made from the results were found to be in
specified limits as per the ICH specifications
 From this we conclude that the equipment is successfully qualified and can be
used for production of further batches.
 The result is considerable variation in the way pharmaceutical companies
approach the qualification of laboratory equipment and requirements.
6/29/2020
18

19. REFERENCES
 EQUIPMENT QUALIFICATION AND VALIDATION OF TABLET
COMPRESSION MACHINE, WORLD JOURNAL OF PHARMACY AND
PHARMACEUTICAL SCIENCES, Volume 2, Issue 6, 5412-5418., ISSN 2278 –
4357, P.Ramasubramaniyan, N.Sharanya, et.al.
 A REVIEW ON QUALIFICATION OF AUTOCLAVE, RMG, FBD, CONE
BLENDER, TABLET COMPRESSION MACHINE, Journal of Global Trends in
Pharmaceutical Sciences, Volume 5, Issue 1, pp-1450-1459, January-March 2014,
ISSN: 2230-7346, B.Venkateswara Reddy, B.Rasmitha Reddy et al.
 I HOLLAND TABLETING SCIENCE, tablettingscience.com
6/29/2020
19

20. 6/29/2020
20