SOP For Operation of Friability Test Apparatus
1.0
Purpose
The purpose of this SOP is to lay down
operational procedure of Friability test Apparatus.
2.0
Scope
This procedure is applicable to Quality Control Department.
3.0
Responsibility
Officer QC
Senior Officer QC
Asst. Manager QC
Manager QC
4.0
Accountability
Manager QA
5.0
Terms and Definitions
Friability test
Friability is a physical testing procedure of
compressed and uncoated tablets to determine its strength upon exposure to
mechanical shock and abrasion. It includes weight loss determination that
should not be less than 1.0%.
6.0
Precautions
6.1
Check all the
connections and circuits before use
6.2
Wear mask and
gloves while operating the instrument.
6.3
Don’t open the
compartment during operation.
6.4
Discard the
tested material as per solid waste management procedure.
7.0
Reference
N/A
8.0
Procedure
8.1
Weight accurately
the number of tablets for the test
8.2
Remove cover of
the drum and put the weigh sample of tablets.
8.3
Replace the cover
of the drum and tight properly with the help of knob.
8.4
Turn “ON” the
main power.
8.5
Press the timer key
to set the time for 4 minutes.
8.6
Press “enter” key
to start the test.
8.7
After the
prescribed time remove the cover of the drum.
8.8
Take out the
tablets sample and weigh again.
8.9
Determine the weight
loss and calculate the Friability as per given formula.
8.10
Make entry in the
Friabilator log book.
8.11
Turn “OFF” and
properly clean the apparatus.
9.0
Abbreviations
9.1 SOP Standard Operating Procedure
9.2
QC Quality Control
9.3
QA Quality Assurance
10.0
Annexure
N.A
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