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SOP for Cleaning Procedure for Dissolution Test Apparatus

OBJECTIVE
To lay down the procedure for cleaning of Dissolution Test Apparatus 

SCOPE 
This SOP shall be applicable for Dissolution Test Apparatus installed in Quality Control Laboratory. 

RESPONSIBILITY 
Technical Assistant/ Helper.
Q.C Analyst.

ACCOUNTABILITY
Manager-Quality Control.




PROCEDURE 
  • Lift the stirrer unit by UP ( ) key.
  • Switch “OFF” the instrument.
  • Switch “OFF” the main power supply.

For cleaning of Dissolution apparatus:
Frequency: After completion of every dissolution test.
  • Remove the basket/ paddle apparatus from the dissolution apparatus with the help of a key. Wash them with purified water and dry them with tissue paper and keep in the proper place.
  • Remove the bowl from its place and discard the medium of each bowl. Wash each bowl properly with purified water then keep it inside the dissolution bath number wise.
  • Keep the record in the instrument log card.

Cleaning procedure for water bath of Dissolution test apparatus. 
  • Frequency: Once in a week or whenever necessary. 
  • Remove all the jars from water bath of dissolution test apparatus. 
  • Remove the lid of the water bath and remove the circulating pipe which is provided at the right rear side of the water bath (inlet).
  • Start the circulating pump from the option menu and drain the dirty water in the wastage water bucket.
  • Insert the circulating pipe in its proper place.
  • Wash the water bath with tap water, detergent solution and with tap water sequentially until no foam of detergent remains in the bath. After complete removal of the detergent wash the water bath finally with purified water. 
  • Place the water bath to its position in the dissolution test apparatus. 
  • Put the lid of water bath. Fill the water bath with purified water up to level mark. Any suitable antifungal chemical or solution may be added in the bath, then for further use of dissolution test apparatus refer to SOP “Operation and Calibration of dissolution test apparatus”. 
  • Record the details of cleaning in log book of instrument as per current version of SOP. 
Note: In between when water becomes dirty, change water of water bath. 


ABBREVIATION
SOP - Standard Operating Procedure 
Q.C - Quality control 

ANNEXURE
Annexure 1: Cleaning record for dissolution apparatus water bath (Cleaning Equipment Log Book).

Name of the instrument: _________________________

Make: __________________

Model No.: ______________

Identification: __________________

Date of cleaning

Due date of cleaning

Cleaned by

Checked by

Remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


REVISION HISTORY
Nil

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