SOP For Operation Of Disintegration Apparatus
1.0
Purpose
The purpose of this SOP is to lay down
operational procedure of Disintegration test Apparatus.
2.0
Scope
This procedure is applicable to Quality Control and
Quality Assurance Department.
3.0
Responsibility
Officer QC/QA
Asst. Manager QC/QA
Manager QC/QA
4.0
Accountability
Manager QA
5.0
Terms and Definitions
N/A
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
Avoid excessive force
during removing and placing of basket rack assembly.
6.4
Check water level
in the tank before switching “ON” the apparatus.
6.5
Avoid abrasive
material while cleaning the instrument.
7.0
Reference
N/A
8.0
Procedure
8.1
Ensure that the
instrument and area is properly clean.
8.2
Use DI water in
water bath.
8.3
Fill the beaker
with purified water or other medium if required up to the desired volume.
8.4
Turn “ON” the
main power.
8.5
Turn “ON” the
heater by pressing the temperature button.
8.6
Check that is the
temperature reached the desired temperature i.e 37 oC ± 2.
8.7
Set the time as
per the test requirement using arrow key of time.
8.8 Place one
tablet/capsule in each of the six tubes of basket rack assembly and place disk
if required.
8.9
Turn “ON/OFF” key
to start the oscillation smoothly at constant frequency
8.10
Watch the
tablets/capsules till their complete disintegration.
8.11
Use “ON/OFF”
button to stop the oscillation.
8.12
Make entry in DT
apparatus log book.
8.13
To pass the test
all the tablet/capsule must have disintegrated within specified time.
9.0
Abbreviations
9.1 SOP Standard Operating Procedure
9.2
QC Quality Control
9.3
QA Quality Assurance
9.4
DI Deionized
9.5
DT Disintegration Test
10.0
Annexure
N.A
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