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
- PROCEDURE
- 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 – 00 New SOP
