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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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Component material
The material of each component that contacts the product as shown in Table 3.10 is to be
recorded and kept as record.
Table 3.10 Component material
Component Material
Blending vessel 316 stainless steel
Charging hatches Stainless steel
Discharge valve Stainless steel
Intensifier bar Stainless steel
Lubricants
The lubricants used to operate the blender as mentioned in Table 3.11 are to be recorded with
a mention whether they have contact with the product or not.
Table 3.11 Lubricants
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Equipment safety features
On the control panel there is an emergency stop button
26
. The operation of the emergency
button is covered in “Equipment Control Functions”.
To provide electronically interlocked barrier guards are the responsibility of the customer.
However, it is the responsibility of the user to conduct a thorough hazards operation review
of the installed blender. There are some considerations to be reviewed:
Barrier guarding to protect operators from injury by rotating equipment
Electrical safety and grounding
Exposure to chemical or biological hazards
Safe handling of powders and liquids that may create electrostatic hazards, and
Physical hazards related to cleaning, maintenance, or upset conditions.
Specific hazards are identified by team review and/or by using process hazards identification
software. After identification of process hazards, it becomes the responsibility of the user to
take appropriate action to ensure the continuous safe operation of the process, including the
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blender and related equipment. In such cases, action such as modification of the design of
the equipment, guarding, and protective clothing or appliances for operators, or specific
training should be recommended.
Operational Qualification (OQ)
An OQ should state that the equipment can operate within the specified tolerance and limits.
The mechanical ranges of the blender are challenged, along with the basic blender
operations. The blender can be validated for its ability to operate, not how well it can blend
the powders. Information necessary for the OQ evaluation is calibration of the instruments
used to control the blender, equipment control functions (switches and push buttons), and
equipment operation (rotation of the blender motor and intensifier bar motor, speed of
blender tip and intensifier bar). The elements of OQ elements of a V-shell blender is shown
in Fig. 3.5.
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Fig. 3.5 OQ elements of a V-shell blender
Calibration requirement
All critical instruments or the equipments have to be registered in the calibration system.
The calibration procedures have to be performed in right place, and are to be used in
calibration
27,28
at the time of qualification testing. The generated results should be
documented as records as mentioned in the Table 3.12.
Table 3.12 Calibrated instruments
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Equipment Control Functions
The purpose of testing equipment control function is to verify whether the switches and push
buttons are working properly as per the manufacturer’s specifications. Each control listed in
Table 3.13 should be operated and its operation is to be verified and the result is to be
entered in tabular form ( Table 3.13 ). The test is to be conducted when the blender is empty.
The generated information must be preserved as record.
Table 3.13 Equipment control function test result
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Equipment Operation: Blender and Intensifier bar rotation direction test
The purpose of rotation direction test is to verify whether the blender and intensifier bar
rotate in the proper direction. Following tests are to be performed with empty blender.
The blender start push button is to be pressed and the direction of rotation of the blender is
observed from the drive side of the blender. The results of the test are recorded as shown in
the Table 3.14 in form of document.
Table 3.14 Direction of rotation of blender and intensifier bar
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Equipment Operation: Blender and Blender Tip Speed Test
The purpose of testing the top speed is to document the speed of blender and its top when the
blender is empty. The results of the test
29
and the instruments used for the test are to be
documented in form of Table shown in Table 3.15 and 3.16.
The speed of the blender is to be calculated and the results are to be noted as shown in the Ta
ble 3.15 and the instruments used for this purpose are to be recorded in the form of Table 3.1
6.
Table 3.15 Blender speed test result
Table 3.16 Instruments used
Equipment Operation: Intensifier Bar Speed Test
The objective of this test is to document the speed of the intensifier bar keeping the blender
empty. A calibrated tachometer is to be used for the test and the results are to be documented
in form of Table as shown in the Table 3.17. The instruments used for this purpose are also
to be documented as shown in Table 3.18.
Table 3.17 Intensifier bar speed test results
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Table 3.18 Instruments used
Result should be Specification ± 0.3 nm
Performance Qualification (PQ)
After establishing that the equipment has been properly installed and is working as per the
specified operating parameters, it must be shown and recorded that the blender can operate
reliably under routine, minimum and maximum operating conditions.
Blender Operation
This test has been designed to record the performance of the blender using a placebo and a
color dye. For maximum loading condition, the placebo is used. Under this condition, the
speed of the blender is calculated, and the speed of the intensifier bar will be measured and
recoded.
The material and the instruments used in this test shall be placebo, dye, scale, a stopwatch,
and a tachometer. The results of this test are recorded, and the details of the instruments used
are to be documented as shown in the Table 3.19 , 3.20 and 3.21.
Table 3.19 Test materials and condition
Item Results
Lactose hydrous
Microcrystalline cellulose 102
Magnesium stearate
Weight of placebo
Dye (Name of the dye used)
Total weight blended
Volume of blended material
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Total blending time
Table 3.20 Blender performance test results
Table 3.21 Instrument used
Validation of a Tablet Press
A rotary tablet press
30,31
is an automatic high speed tableting machine. A motor rotates the
press at high speed and produces few hundreds of tablets per minute depending on the rpm.
The material being compressed is fed from hopper by gravity through the feed frame into
dies. There is a weight controlling cam attached to the press. By regulating this cam, the
individual tablet weight can be adjusted volumetrically. Both upper and lower punches
compress the powder within the die. There is a takeoff bar attached to the feed frame which
removes the tablet from the press.
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Fig. 3.6 PQ elements of V-shell blender
The validation protocol for a tablet press described here can be used as a cGMP compliance
guide and it can be tailored to meet the requirement of an individual company.
Installation Qualification (IQ)
The evaluation of IQ will establish the confidence that the equipment has been properly
installed. The installation must meet the manufacture’s specified guidelines as well as design
changes at installation. The supporting electrical utilities must meet all the electrical codes as
specified by the manufacturer. The IQ elements are shown in Fig 3.7. Following information
are necessary for IQ evaluation:
Equipment identification
Required documentation
Equipment utility requirements
Major component specifications
Component materials
Lubricants
Equipment safety features
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Fig. 3.7 IQ elements of a tablet press
Equipment identification
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The equipment identification numbers as shown in Table 3.22 are to be recorded and
documented. Along with the information, the exact place (location) where the equipment is
being installed is to be mentioned.
Table 3.22 Equipment Identification
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Required documentation
The manuals for the equipment operation and for its maintenance, along with the drawings
as mentioned in the Table 3.23 are to be documented. The SOPs for setting up, operation and
cleaning of the tablet press as shown in Table 3.24 are also to be documented and
maintained.
Table 3.23 Manufacturer’s manual and drawings
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Table 3.24 Standard Operating Procedures
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Equipment utility requirements
The electrical requirements (volt and amperes) recommended by the manufacturer of the
equipment are to be compared with ’as found’ at the installation site, and to be recorded and
documented in the form of Table as shown in Table 3.25. Also the location power supply
source is to be recorded and noted. The instrument used for these measurements is to be
noted and documented as shown in Table 3.26.
Table 3.25 Utilities
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Table 3.26 Instruments used
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Major component specifications
The specifications of the components of the tablet press purchased are to be verified before
and installed. The details of major components are to be recorded in the form of Table 3.27
and the document has to be preserved.
Table 3.27 Major components
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Component materials
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The material used in making the components those would come in contact with the product
is to be recorded in the form of table as shown in Table 3.28.
Table 3.28 Component material
Component Material used
Rotor head Mild steel (say)
Hopper Stainless steel (say)
Punches Mild steel (say)
Dies Mild steel (say)
Lubricants
The lubricants used to operate the machine are to be recorded with a mention whether they
are in contact with the product or not, as shown in Table 3.29.
Table 3.29 Lubricants
Equipment safety features
The purpose of this test is to examine the equipment safety features of the Tablet press
whether are according to the manufacturer’s specification or not and to record the results in
form of table as shown in the Table 3.30
Table 3.30 Safety Features Test Results
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Operational Qualification (OQ)
The OQ evaluation of a tablet press should establish that the press can operate within the
specified tolerances and limits. The mechanical ranges of the tablet press are to be
challenged, along with basic tablet press operation. The tablet press will be validated for its
operating validity, not how well it can compress the tablets. Information necessary for OQ
evaluation is the calibration of the instruments used to control the tablet press, equipment
control functions (switches and push buttons) and equipment operation (cam tracks, upper
punches, lower punches, feed frames, takeoff bars, rotor head rotation direction, and speed
of the tablet press). Evaluation of OQ means evaluation of the following parameters
Fig. 3.8 OQ elements of a tablet press
Calibration Requirements
Whether all the critical instruments of the tablet press have been recorded in the calibration
system are to be verified, whether calibration procedures are in place, and the instruments
used at the time of qualification were calibrated – these are to be verified and recorded in the
form of table as shown in the Table 3.31
Table 3.31 Instrument used during installation
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