Dissolution apparatus cleaning SOP

1.0  OBJECTIVE:

To lay down the procedure for cleaning of Dissolution apparatus.

2.0  SCOPE:

This shall be applicable to the Dissolution 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  Waste bucket.

5.5  Purified water.

6.0  PROCEDURE:

6.1  Lift the stirrer unit by UP ( ) key.

6.2  Switch “OFF” the instrument.

6.3  Switch “OFF” the main power supply.

6.4  For cleaning of Dissolution apparatus:

6.4.1        Frequency: After completion of every dissolution test.

6.4.2        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.

6.4.3        Remove the basket/ paddle apparatus from the dissolution apparatus. Wash them with purified water and dry with tissue paper and keep at proper place.

6.4.4        Keep the record in the instrument log card.

6.5  For cleaning of water bath of Dissolution apparatus:

6.5.1        Frequency: Once in a week, if necessary.

6.5.2        Remove all the bowls from water bath.

6.5.3        Remove the baskets/ paddle apparatus from the stirrer unit.

6.5.4        Remove the circulating pipe which is provided at right rear side of water bath (inlet).

6.5.5        Start the circulating pump from the option menu and drain the dirty water in wastage water bucket.

6.5.6        Insert the circulating pipe in its proper place.

6.5.7        Wash the bath with purified water, detergent solution and purified water sequentially, until no foam of detergent remains in the bath. After complete removal of the detergent, wash the bath finally with purified water.

6.5.8        Fill the bath with purified water up to level mark.

6.5.9        Record it as per Annexure-1.

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

6.6  Precautions:

6.6.1        Do not use abrasive materials to clean the instrument.

6.6.2        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 dissolution apparatus water bath (Cleaning Equipment Log Book).

Annexure: 1

(Cleaning Equipment Log Book)

Cleaning record for dissolution apparatus water bath.

Name of the instrument: _________________________ Make: __________________ Model No.: ______________ Identification: __________________ Date of cleaning 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
F	Format