SOP for Cleaning Procedure for Dissolution Test Apparatus : Pharmaguideline

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SOP for Cleaning Procedure for Dissolution Test Apparatus

Standard operating procedure to clean the dissolution test apparatus.

1.0 OBJECTIVE

To lay down the procedure for cleaning.

2.0 SCOPE

This procedure is applicable to all dissolution test apparatus, installed in the quality control laboratory

3.0 RESPONSIBILITY

3.1 Doing: Worker
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Raise the motor driven to the upper side by Up/Stop/Down switch.
5.2 Switch ‘OFF’ the instrument.
5.3 Switch ‘OFF’ the Main.
5.4 Cleaning procedure for Apparatus
Frequency: After completion of every dissolution test.
5.4.1 Remove the bowl from its place discard the medium of the bowl and wash each bowl properly with purified water then keep inside the dissolution bath number wise.
5.4.2 Remove the baskets from Basket apparatus and then basket/paddle from the dissolution test apparatus with the help of the key. Wash them with purified water, dry with tissue paper and keep at a proper place.
5.4.3 Keep the record in the instrument log card.
5.5 Cleaning procedure for water bath of dissolution test apparatus.
Frequency: Once in a week or whenever necessary
5.5.1 Remove all the bowls from the water bath and the apparatus.
5.5.2 Remove the lid of the water bath and discard all the water from the water bath.
5.5.3 Wash the bath with raw water, detergent solution and with raw water sequentially until no foam of detergent remains in the bath. After complete removal of the detergent wash the bath finally with purified water.

5.5.4 Keep the bath to its the original place and clean the dissolution apparatus.
5.5.5 Record it as per Annexure.
5.5.6 Put the lid of the water bath and fill bowls with the medium in the apparatus. Fill the bath with purified water up to the level mark.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
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