SOP for Cleaning of Disintegration Test Apparatus : Pharmaguideline

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SOP for Cleaning of Disintegration Test Apparatus

Standard operating Procedure to clean the disintegration test apparatus.

1.0 OBJECTIVE

To lay down for procedure for cleaning of disintegration test apparatus.

2.0 SCOPE

This procedure is applicable for all disintegration test apparatus, installed at quality control laboratory.

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant
3.2 Checking : Technical Assistant /Executive

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Switch ‘OFF’ the instrument.
5.2 Switch ‘OFF’ the Main.
5.3 For Cleaning of Assembly
Frequency : After every test
5.3.1 On completion of every disintegration test, remove the beakers and assembly along with discs.
5.3.2 Wash them properly with purified water and keep aside.
5.3.3 Record in the log card of instrument .
5.4 For Water bath
Frequency : Once in a week
5.4.1 Switch ‘off’ the instrument.
5.4.2 Remove the external probe from water bath.
5.4.3 Remove beakers along with the assembly from water bath of the disintegration test apparatus.
5.4.4 Remove the lid and heater electrical connector from water bath.
5.4.5 Remove the water bath and discard water from it into respective container.
5.4.6 Wash the water bath with raw water, detergent solution and then with raw water until no foam of detergent remain in the bath. After complete removal of all detergent, wash the bath with purified water.
5.4.7 Clean the external surface with wet cotton cloth and finally clean with lint free cloth.
5.4.8 Place the water bath on its original place.
5.4.9 Fill the water bath with purified water upto the level indicated on the external surface of the water bath.
5.5 After cleaning of the disintegration test apparatus, record it as per Annexure-I.
N.B.: In between when water become dirty change water as per step.No.5.4.

Related: Calibration of Disintegration Test Apparatus

6.0 ABBREVIATIONS

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

ANNEXURE-I

Q.C.DEPARTMENT
CLEANING RECORD FOR DISINTEGRATION WATER BATH
NAME OF TH E INSTRUMENT :
MAKE                                             :
MODEL NO                                    :
IDENTIFICATION                        :

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




























































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