Disintegration apparatus Cleaning SOP

1.0  OBJECTIVE:

To lay down the procedure for cleaning of Disintegration apparatus.

2.0  SCOPE:

This shall be applicable to the Disintegration apparatus of Quality Control Instrument Lab.

3.0  RESPONSIBILITY:

3.1  Technical Assistant/ Helper.

3.2  Q.C Analyst.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

5.0  MATERIAL AND EQUIPMENT:

5.1  Disintegration apparatus.

5.2  Detergent.

5.3  Lint free cloth.

5.4  Purified water.

6.0  PROCEDURE:

6.1  Switch “OFF” the instrument.

6.2  Switch “OFF” the main power supply.

6.3  For cleaning of Assembly:

6.3.1        Frequency: After every test.

6.3.2        On completion of every test disintegration test, remove the beakers and assembly along with discs.

6.3.3        Wash them properly with purified water and keep aside.

6.3.4        Record in the log card of instrument.

6.4  For water bath:

6.4.1        Frequency: Once in a week.

6.4.2        Switch “OFF” the instrument.

6.4.3        Remove the external probe from water bath.

6.4.4        Remove beakers along with the assembly from the water bath of the disintegration test apparatus.

6.4.5        Remove the lid and heater electrical connector from water bath.

6.4.6        Remove the water bath and discard water from it into respective container.

6.4.7        Wash the water bath with purified water, detergent solution and then with purified water until no foam of detergent remain in the bath. After complete removal of all detergent, wash the bath with purified water.

6.4.8        Clean the external surface with wet cotton cloth and finally clean with lint free cloth.

6.4.9        Place the water bath on its original place.

6.4.10    Fill the water bath with purified water up to the level indicated on the external surface of water bath.

6.4.11    After cleaning of the disintegration test apparatus, record it as per Annexure-1.

6.4.12    When water become dirty change water as per step 6.4.

6.4.13    Affix the “CLEANED” label and fill the “Cleaning Equipment Log Book”.

6.5  Precautions:

6.5.1        Do not use abrasive materials to clean the instrument.

6.5.2        Do not bend the heater while cleaning the water bath.

7.0  REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

8.0  REFERENCES:

8.1  Not Applicable.

9.0  ANNEXURES:

Annexure 1: Cleaning record for disintegration water bath (Cleaning Equipment Log Book).

Annexure: 1

(Cleaning Equipment Log Book)

Cleaning record for disintegration water bath.

Name of the instrument: _________________________ Make: __________________ Model No.: ______________ Identification: __________________ Date of cleaning of water bath Due date of cleaning Cleaned by Checked by Remarks

10.0    ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
QCEC	Quality control equipment cleaning
Q.C	Quality control