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 the Quality Control Laboratory. 

RESPONSIBILITY 

Technical Assistant/ Helper.

Q.C Analyst.

ACCOUNTABILITY
Manager-Quality Control.

PROCEDURE 

• Lift the stirrer unit with the 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 them 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 a week or whenever necessary. 
• Remove all the jars from the water bath of the 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 options menu and drain the dirty water in the waste 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 on the water bath. Fill the water bath with purified water up to the level mark. Any suitable antifungal chemical or solution may be added in the bath, then for further use of the dissolution test apparatus refer to SOP “Operation and Calibration of dissolution test apparatus”. 
• Record the details of cleaning in the log book of the instrument as per the current version of SOP. 

Note: In between when water becomes dirty, change the water of the 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

ALSO READ: SOP for Calibration of Disintegration Apparatus (Make: Electrolab)