SOP for Cleaning of Dissolution Tester : Pharmaceutical Guidelines

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SOP for Cleaning of Dissolution Tester

Standard operating procedure to clean the dissolution tester including bowls, baskets and paddles.

1.0 OBJECTIVE

To lay down the procedure for cleaning.

2.0 SCOPE

This procedure is applicable to dissolution tester installed in 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 Lift the Stirrer Unit by UP(­) key.
5.2 Switch ‘OFF’ the heater.
5.3 Switch ‘OFF’ the instrument.
5.4 Switch ‘OFF’ the main.
5.5 Cleaning procedure for Apparatus
Frequency: After completion of every dissolution test.
5.6 Remove the bowl from its place and discard the medium of each bowl. Wash each bowl properly with R.O. water then keep it inside the dissolution bath number wise.
5.7 Remove the basket/paddle apparatus from the dissolution tester. Wash them with R.O. water and dry with tissue paper and keep at the proper place.
5.8 Keep the record in the instrument log card.
5.9 Cleaning procedure for water bath of Dissolution Tester.
Frequency: Once in a week or if necessary.
5.10 Remove all the bowls from the water bath.
5.11 Remove the baskets/paddle apparatus from the stirrer unit.
5.12 Remove the circulating pipe which is provided at the right rear side of the water bath (inlet)
5.13 Start the Circulating Pump from the options menu and drain the dirty water in wastage water bucket.
5.14 Insert the Circulating Pipe in its proper place.
5.15 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 R.O. water
5.16 Fill the bath with R.O. water up to the level mark.
5.17 Record it as per Annexure-I.

Related: Calibration of Dissolution Tester

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 R.O. water - Reverse Osmosis Water.


ANNEXURE-I
Q.C. DEPARTMENT
CLEANING PROCEDURE FOR DISSOLUTION TEST APPARATUS
NAME OF THE INSTRUMENT :
MAKE                                           :
MODEL NO                                  : TDT-08  L
IDENTIFICATION  NO.

Date  of cleaning
Due date of cleaning
Cleaned by
Checked by
Remarks








































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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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