SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company

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

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