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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5670_Библиотеки_им_академика_М_И_Перельмана
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Equipment Control Functions
The purpose of equipment control function test is to verify whether the switches and push
buttons are working as per the manufacturer’s specifications. The results of this test are to be
recorded in the form of table 3.32. The test should be performed when the tablet press is
empty. Proper operation of each of the components mentioned in the list is to be verified.
Table 3.32 Equipment Control Functions Test Results
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Equipment Operation: Cam Tracks Test
The purpose of the cam tracks test is to verify that the upper and lower cam tracks make
contact with the upper punches according to the specifications of the manufacturer. The
results of the test are to be recorded as per the Table 3.33.
The punches are to be installed and to be verified whether the cams are contacting the punch
head angles on both sides of the double sided cams.
Whether the punches should contact one side of the single-sided cam through a full cam
track, upper and lower is to be verified.
Table 3.33 Cam tracks Test Results
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•
•
•
Equipment Operation: Upper Punch Test
The purpose of the upper punch test is to verify that the upper punch penetration is according
to the manufacturer’s specification. For this test, a vernier caliper would be required. This is
to be performed as follows:
A piece of tape is attached to mark the depth of penetration of an upper punch when it
is set to a standard depth.
The upper punch is to be removed and the depth of penetration of the upper punch is
to be measured by using a calibrated vernier caliper when it is set to a standard depth.
The results of this test and details of the instrument used for this purpose are to be
recorded in the form of Table 3.34 and 3.35.
Table 3.34 Upper punch test result
Table 3.35 Instrument used
Equipment Operation: Lower Punch Test
The purpose of the lower punch test is to verify whether the lower punch height is set
according to the manufacturer’s specification or not. For this test a dial indicator is
necessary. The height of the lower punch above the die is to be measured with a dial
indicator and the results are to be recorded in the Table 3.36 and preserved. The instrument
used to measure the height is recorded in the Table 3.37.
Table 3.36 Lower Punch Test Results
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Table 3.37 Test Instrument used
Equipment Operation: Feed Frame Test
The purpose of this test is to verify whether the feed frame distance above the rotor head is
according to the manufacturer’s specification. A feeler gauge is necessary for this test. The
clearance between the feed frame and rotor head is to be measured with a feeler gauge and
the results are to be recorded in Table 3.38. The instrument used to measure the clearance is
also to be recorded in Table 3.39.
Table 3.38 Feed Frame Test Results
Table 3.39 Test Instrument used
Equipment Operation: Takeoff bar Test
The purpose of this test is to verify whether the takeoff bars do not make contact with the
lower punches or not. The tablet press is to be turned by hand and to check whether the
takeoff bars do not make contact with the lower punches. The results are to be recorded in Ta
ble 3.40.
Table 3.40 Take-off Bars Test Results
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Equipment Operation: Rotation Direction of Tablet Press
This test is done to verify whether the rotor head rotates in proper direction or not. The test
will be performed with empty tablet press. The start switch is to be pressed and the direction
of rotation of the rotor head is observed from in front of the press and the results of the test
are to be recorded in Table 3.41.
Table 3.41 Test for direction of rotation of the rotor head
Equipment Operation: Speed of Tablet Press
The speed test is performed to verify that the measured speeds are within ± 10% of the
manufacturer’s specification of minimum of say 9 rpm and maximum of 36 rpm. This test is
to be performed keeping the press empty. To carry out this test a calibrated stopwatch would
be required. The speed of the rotor head is to be measured and entered into the Table 3.42 ,
and to be kept as record along with the details of the instrument used in Table 3.43.
Table 3.42 Tablet press Speed test results
Table 3.43 Instrument used
Performance Qualification (PQ)
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Fig. 3.9 PQ elements of a tablet press
Once it is established that the equipment has been properly installed and working within
specified operating parameters, it becomes necessary to show that the tablet press can work
reliably under routine, minimum, and maximum operating conditions ( Fig 3.9 ).
Tablet Press Operation: Tablet Weight Hardness
The purpose of this test is to verify whether the tablet weight and hardness can be
maintained consistent throughout the entire weight and hardness setting range.
The materials and instrument required for this test are a placebo and a weight, hardness, and
thickness gauge. Tablets are to be compressed using placebo granules. The placebo used to
be recorded in Table 3.44. The average weight and hardness of 5 tablets are measured at 0,
10, 20, and 30 min after starting the compression. The results are to be presented in Table 3.4
4 to 3.46. The calibration details of the instruments used to measure the weight and hardness
are to be presented in Table 3.47.
Table 3.44 Test material used
Item Substance used
Test placebo Haloperidol
Table 3.45 Tablet weight test results
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Table 3.46 Tablet Hardness test results
Table 3.47 Instrument used
Tablet Press Operation: Tablet Press Speed Test
The purpose of this test is to record the performance of the tablet press using placebo and to
verify whether the tablet press can maintain the consistent tableting speed throughout the
tableting speed range. The varying speeds of the tablet press will have to be calculated and
recorded in the Table 3.48. The test material used during the test is to be recorded in the Tabl
e 3.49 ; similarly the calibration details of the instruments used in the test are also recorded
in the Table 3.50.
Table 3.48 Tablet Press Speed Test Result
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Table 3.49 Test material used
Item Substance used
Test placebo Haloperidol
Table 3.50 Instruments used
Note: tpm = rpm × 45
Validation of Specific Dosage Form
Validation of Solid Dosage Form
Various factors should be considered
30-32
to develop and validate solid dosage forms. To
provide a broad overview of the validation criteria, the following guidelines for tablets and
dry-filled capsules have been mentioned in table 3.51 below. Some of these unit operations
will not be applicable for every dosage form such as directly compressed tablets and
uncoated tablets.
Protocol for Process Validation
The protocols for process validation have been provided in tables 3.51, 3.52 , 3.53 and in 3.5
4.
Table 3.51 Protocol for title page in industry
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Table 3.52 Protocol approval
Table 3.53 Table of contents
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Table 3.54 Validation team and Responsibilities
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