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SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company
OBJECTIVE
To lay down a procedure for Operation of Tablet Disintegration Tester (Make –Electrolab Model- ED2AL).
SCOPE
This Standard Operating Procedure (SOP) is applicable to test the disintegration time of the tablets during in process/ QC samples analysis.
RESPONSIBILITY
IPQA / QC/Production Executive / Officer
ACCOUNTABILITY
Head –Quality Assurance
Ensure that the apparatus is clean, before use.
Ensure that the bath is filled with purified water upto the level marked and is without any debri. If required replace the water in the water bath.
Place the bath top plate on the bath such that the cut on the plate matches with the notch on the bath. Set the bath temperature 37°C
Place the beakers, filled with 900 ml purified water, on the beaker stand inside the bath.
Fix the six-tube basket rack assembly in the individual slot of horizontal clamp.
Switch ON the instrument.
Set the temperature using [set], [temp] and arrow keys and finally pressing the [ENTER] key.
Start the temperature controller by pressing the [TEMP] key.
To run the machine in Timer mode or manual mode, press the Timer/ manual toggle key.
Program the timer as required using the [SET], [TIMER] and arrow keys and finally pressing the [ENTER] key.
Wait till the temperature of media in the beaker reaches to the set temperature.
Put the sample tablets, one each in six tubes of basket assembly and put one disc in each tube.
Start the timer(s) by pressing [START/STOP] and [TIMER] key.
Note down the time when no residue remains on the wire mesh or if there is a residue, it consists of a soft mass having no palpably firm, unmoistened core.
The DT is considered as the time when the last tablet has disintegrated.
Switch OFF the instrument.
Clean the bath fortnightly or early if required.
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
Date
Revision Number
Reason for Revision
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00
New SOP
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