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SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR

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STANDARD OPERATING PROCEDURE


DEPT. ENGINEERING

CLEANING PROCEDURE FOR PRE FILTER OF FORCED DRAUGHT


TITLE
VENTILATION

SOP No. P2EG-012-R3 Copy

Effective Date 01 June 2012 Review Date 31 May 2015

DISTRIBUTION RECORD OF NEW SOP

New SOP received by Old SOP received from


Copy Date of Date of
Department
No. Issuance receipt
Name Sign. Name Sign.

01 Master Copy

02 Display Copy

03 Engineering

DESTRUCTION RECORD (old copies)

No. of copies Method of destruction

Destroyed by Sign. Date

Witnessed by Sign. Date

CC 1 2 0 0 2 EG
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR

Page 1 of 3

STANDARD OPERATING PROCEDURE


DEPT. ENGINEERING

CLEANING PROCEDURE FOR PRE FILTER OF FORCED DRAUGHT


TITLE
VENTILATION

SOP No. P2EG-012-R3 Copy

Effective Date 01 June 2012 Review Date 31 May 2015

1.0 OBJECTIVE:
To provide the detail procedure for cleaning of pre filter of forced draught ventilation.

2.0 SCOPE:
This procedure is applicable for the operation of Cleaning Procedure for Pre Filter of all FDV & EXF of
Symbiotec Pharmalab Limited. Plant No.-2, Located at Special Economic Zone Pithampur.

3.0 RESPONSIBILITY:

Operator : To Clean for filter of all FDV & EXF Unit as per the standard operation
procedure.
Officer / Executive : To ensure proper Clean for filter of all FDV & EXF Unit and supervise the
various activities being carried out by operator.
Engineering Head : To ensure that the operation activity is carried out as per standard
Procedure and all records are maintained in a timely manner.

4.0 APPROVALS:

Concerned persons and quality assurance department are responsible to approve each page of SOP
with their name, designation, signature and date.

5.0 PROCEDURE:

5.1 Switch “OFF” the main switch of FDV.

5.2 Open suction side door of Supply FDV & remove the filter from filter Frame.

5.3 Shift the filter FDV unit to the Filter Cleaning Area.

5.4 Apply compressed air in reverse direction of airflow ( Airflow direction marked on each filter) to remove

Name Designation Signature Date


Prepared By Ashish Joshi Engineer – Engineering
Reviewed By R. K. Gupta Sr.Manager - Engineering
Approved By Pradeep Birthare DGM – Quality
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR

Page 2 of 3

STANDARD OPERATING PROCEDURE


DEPT. ENGINEERING

CLEANING PROCEDURE FOR PRE FILTER OF FORCED DRAUGHT


TITLE
VENTILATION

SOP No. P2EG-012-R3 Copy

Effective Date 01 June 2012 Review Date 31 May 2015

Accumulated dust.

5.5 Apply raw water with jet in reverse direction of airflow ( Airflow direction marked on each filter) to

wash the filter.

5.6 Apply compressed air in reverse direction of airflow to remove Water.

5.7 Again apply compressed air from airflow direction.

5.8 Again apply water with jet from from airflow direction.

5.9 Again apply compressed air from airflow direction.

5.10 Do this exercise for 2 to 3 times

5.11 After completion of cleaning, shift it to FDV unit.

5.12 Refit the filters in filter frame & shut down the both door.

5.13 Apply same procedure for the cleaning of Exhaust FDV filters.

5.14 Switch “ON” main switch of FDV

5.15 Pre Filters should be cleaned once in a month.

6.0 RECORD:
6.1 Cleaning record.

7.0 ANNEXURES:
7.1 Record for Prefilter cleaning of FDV/EXF.
7.2 List of Air distributed area of FDV.

8.0 REFERENCES:
In house

Name Designation Signature Date


Prepared By Ashish Joshi Engineer – Engineering
Reviewed By R. K. Gupta Sr.Manager - Engineering
Approved By Pradeep Birthare DGM – Quality
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR

Page 3 of 3

STANDARD OPERATING PROCEDURE


DEPT. ENGINEERING

CLEANING PROCEDURE FOR PRE FILTER OF FORCED DRAUGHT


TITLE
VENTILATION

SOP No. P2EG-012-R3 Copy

Effective Date 01 June 2012 Review Date 31 May 2015

9.0 ABBREVIATIONS AND DEFINITIONS (IF ANY):

EG : Engineering
FDV : Forced Draught Ventilation
EXF : Exhaust Fan

10.0 Revision History

Revision No. Summary of change Change Control no. Effective date

R0 New SOP -- 18 August 2009

Cleaning procedure explain in


R1 CC10005EG 01 January 2011
brief and Annexure add

R2 Format number revised CC11001EG 01 June 2011

R3 Format is replaced by log book CC12002EG 01 June 2012

Name Designation Signature Date


Prepared By Ashish Joshi Engineer – Engineering
Reviewed By R. K. Gupta Sr.Manager - Engineering
Approved By Pradeep Birthare DGM – Quality
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR
Page i of i

Format No.: P2EG-F-009-R3


RECORD FOR PRE FILTER CLEANING OF FDV/EXF
Month / Year : Area :
Checked
Sr. FDV/EXF FDV/EXF FDV/EXF Pre Filter Cleaned by
Date by Engg.
No. ID Stop Time Start Time Cleaning Status Sign./ Date
Sign./ Date

Reviewed by:
Sign & Date:

Page i of ii
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR
ANNEXURE – 2

List of Air distributed area of FDV

Ref SOP No.: P2EG-012-R3 Effective Date : 01 June 2012

Department: - Production unit-I

S.No. FDV No. Location for distributed air by FDV

1. P2U1FDV01 Ground floor material entry and Bag washing.

2. P2U1FDV02 Ground floor Air lock, CF room bag washing, bag drying and store.

3. P2U1FDV03 RVD technical area, air lock and PPE change room.

4. P2U1FDV04 Firs floor technical are and 16KL GLR area.

5. P2U1FDV05 Second floor RM store and passage.

6. P2U1FDV06 Second floor technical area, HAS 230 Liter, GLR and SSR-01

7. P2U1FDV07 Service Area for FDV

8. P2U1FDV08 Water plant and Electrical panel room

9. P2U1FDV09 IPQC and Ground floor first change room

10. P2U1FDV10 Charcoal room and PPE Change room

Department: - Production unit-II

S.No. FDV No. Location for distributed air by FDV

1. P2U2FDV01 Dryer room technical area, PPE Change room and Quarantine room.

2. P2U2FDV02 Finished product room, Passage(2 meter) and Passage(2.5 meter)

3. P2U2FDV03 Technical Area GLR, Carbon room, CF room, PPE Change room, Bag drying and
washing

Page ii of ii
SYMBIOTEC PHARMALAB LIMITED, PITHAMPUR
ANNEXURE – 2

List of Air distributed area of FDV

Ref SOP No.: P2EG-012-R3 Effective Date : 01 June 2012

Department: - Warehouse.

S.No. FDV No. Location for distributed air by FDV

1. P2WHFDV01 Service Area of AHU and magenine floor

2. P2WHFDV02 Office, Passage, Reject room and Battery charging room.

3. P2WHFDV03 Liquid dispensing and Store

Department: - Fermentation

S.No. FDV No. Location for distributed air by FDV

1. P2U4FDV01 Ground floor, Lab Fermenter – 01 room and Change room.

2. P2U4FDV02 Ground floor, Lab Fermenter – 02 room and Change room.

3. P2U4FDV03 First floor, Lab Fermenter room, Air lock and Change room.

4. P2U4FDV04 Inoculums Lab, Media store, Passage and Wet lab Area.

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