SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Standard Operating Procedure Document No. SOP/ENG/074 DISTRIBUTION

TITLE PERIODIC SANITISATION OF PURIFIED WATER SYSTEM Revision No. 04 Date Issued: 25-04-2004 Review Due: April, 2006 PAGE 1 OF 5

1. DGM, Quality Assurance 2. Quality Control Manager

3. Engineering Manager

4. Production Manager
5. Engineering Executive

6. Engineering Officer
7. Archive Copy

CHANGE HISTORY
DATE 01-09-2001 30-09-2002 REVISION 01 02 DESCRIPTION OF CHANGE Original Document 1. In Distribution and in section 5.2 write Water Treatment Supervisor instead of Water Treatment Operator. 2. In section 5.1 write Manager, Maintenance instead of Engineering Manager. 18-09-2003 03 1. Production Manager replaced by Manufacturing Manager in Distribution. 2. Water Treatment Supervisor replaced by Engineering Supervisor in Distribution & 5.2 3. Replace sanitation by sanitisation in Purpose. 4. Add Operating & Maintenance Manual of Purified Water System, volume 1 of 2 in place of Nil in Associated Documents. 5. Write >3 seconds instead of >1sec. in second sentence of 7.2 6. Add new statement 7.5 7. Add Appendix A: Sanitisation Record of PW System.

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature

SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Standard Operating Procedure Document No. SOP/ENG/074

TITLE PERIODIC SANITISATION OF PURIFIED WATER SYSTEM Revision No. 04 Date Issued: 25-04-2004 Review Due: April, 2006 PAGE 2 OF 5

25-04-2004

04

1. Replace AGM, Quality Assurance, Manufacturing Manager & Engineering Supervisor by DGM, Quality Assurance, Production Manager & Engineering Officer in Distribution. 2. Replace Manager, Maintenance, Engineering Supervisor & AGM, Quality Assurance by Engineering Officer, Engineering Helper & DGM, Quality Assurance in 5.1, 5.2 & 5.3 respectively. 3. Replace monthly by once in a month in 7.5

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature

SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Standard Operating Procedure Document No. SOP/ENG/074

1.

TITLE PERIODIC SANITISATION OF PURIFIED WATER SYSTEM Revision No. 04 Date Issued: 25-04-2004 Review Due: April, 2006 PAGE 3 OF 5

PURPOSE
To describe the periodic heat sanitisation of purified water system.

2.

SCOPE
Applicable to the ring main and storage tank of purified water system.

3.

ASSOCIATED DOCUMENTS
Operating & Maintenance Manual of Purified Water Treatment System, Volume 1 of 2.

4.

DEFINITIONS
Nil

5.
5.1 5.2 5.3

RESPONSIBILITIES
Engineering Officer is responsible for supervision of sanitisation. Engineering Helper is responsible for carrying out the sanitisation. DGM, Quality Assurance decides whether sanitisation is necessary.

6.
6.1 6.2 6.3

PRECAUTIONS
Allow only trained staff to carry out the work. Inform all personnel working in the process areas prior to sanitisation. Attach SANITISING sticker on purified water pipes in the process areas.

7. 7.1

PROCEDURE
Sanitisation is an automatic cycle. The cycle is controlled by Cscape software loaded in a GE Fanuc PLC and a REX D400 temperature controller (TX502) on Control Panel CP03. Fanuc controls time (in seconds) of different phases of sanitisation as well as displays status and alarm. The times set are maximum 18000 seconds for heating upto the sanitisation hold temperature; 5400 seconds for holding at sanitisation hold temperature and maximum 18000 seconds for cooling down to normal ring main temperature. Sanitisation temperature 85C and cooling temperature 20C are set at TX502 controller.

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature

SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Standard Operating Procedure Document No. SOP/ENG/074 7.2

TITLE PERIODIC SANITISATION OF PURIFIED WATER SYSTEM Revision No. 04 Date Issued: 25-04-2004 Review Due: April, 2006 PAGE 4 OF 5

Initiate sanitisation sequence manually by turning the sanitisation sprung selector switch to the right, for >1 second, on the Control Panel CP03.The sanitisation can be cancelled at any time by turning the sanitisation sprung selector switch to the right, for >3 seconds.If the temperature is above 20 C the cycle first jumps to the cool stage.

7.3

Sanitisation Interlocks & Alarms - the following interlocks/alarms are provided to ensure the safety of the system during sanitisation: If temperature sensor TE502 is activated during sanitisation, the cycle will go to the cool stage and the appropriate stage fail message alarm activated in addition to the Sanit. Overtemp Alarm.

7.3.1

7.3.2 7.3.3 7.3.4 7.3.5

Sanitisation cannot be initiated unless the all sanitisation alarms are cleared. Should the purified water pump stop during sanitisation, the cycle will go to the cool stage and the appropriate stage fail message alarm activated. The purified water pump must be running to enable the initiation of a sanitisation. A sanitisation cannot be initiated unless water is present. The bursting disk fail signal will close the steam shut off valve CV506, stop the purified water pump and activate a bursting disk fail alarm. If no alarm exists, the sanitisation programme carries out the following stages: Reduce tank volume the volume of purified water within the purified water tank (T501) is reduced to the intermediate level (50%) by opening dump valve CV503 and allowing the purified water to flow to the drain.

7.3.6 7.4 7.4.1

7.4.2

Heat water the water within the ring main is heated to a temperature of 85C by opening steam shut off valve CV506 and steam modulating valve CV504. Upon reaching the sanitisation temperature of 85C as measured by TE501 at the purified water tank outlet, the cycle steps to the next stage. If the temperature fails to reach 85C within the maximum duration of 18000 seconds a Sanit. Heat Fail alarm activates and the cycle jumps to cool stage.

7.4.3

Hold temperature to ensure that the ring main is properly sanitised, maintain the temperature at 85C for 5400 seconds. The temperature is controlled by controlling the steam modulating valve CV504 from the set point on the PID controller TX502. If the temperature falls below 80C, a Sanit. Hold Fail alarm is activated and the cycle jumps to

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature

SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Standard Operating Procedure Document No. SOP/ENG/074

TITLE PERIODIC SANITISATION OF PURIFIED WATER SYSTEM Revision No. 04 Date Issued: 25-04-2004 Review Due: April, 2006 PAGE 5 OF 5

cool stage. If the temperature rises above 900C a Sanit. Overtemp and Sanit. Hold Fail alarm is activated and the cycle jumps to cool stage. 7.4.4 Cooling before completion of the sanitisation, the water is cooled to 20C at temperature sensor TE501 by opening the cooling valve CV505. If the ring main fails to cool to 20C within 18000 seconds, a Sanit. Cool Fail alarm is activated and the cycle remains in the cool stage until the temperature is reached. 7.5 Frequency of sanitisation sanitise the purified water system once in a month and record it in the Sanitisation Record of PW System sheet (Appendix-A).

8.

APPENDICES
A. Sanitisation Record of PW System.

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature

SQUARE PHARMACEUTICALS LIMITED DHAKA UNIT

Prepared by Reviewed by Approved by

Name Swapan Kumar Sarker Mahbubur Rahman Prabir Ghose

Designation Officer, Engineering Engineering Manager DGM, Quality Assurance

Signature