STANDARD OPERATING PROCEDURE SANITIZATION OF MANUFACTURING AND PACKING AREAS& EQUIPMENT (ALL AREAS EXCEPT LIQUID LINE-1)

STANDARD OPERATING PROCEDURE

SUBJECT:                      SANITIZATION OF MANUFACTURING AND PACKING AREAS& EQUIPMENT (ALL AREAS EXCEPT LIQUID LINE-1)

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for Sanitization of Manufacturing areas equipment.    

2.0       POLICY:  

To ensure establish a procedure for sanitization of manufacturing and Packing areas and equipment.

3.0       PROCEDURE:

3.1       Samples are to be drawn only after the Sanitization.

3.2       The position for the swab contact includes top of the lid ends of the tank, inside of the lids and the inner surface of the tank, shaft of the agitator, pump housing and  inside of the discharge points.

3.3       Rub the moistened pre-sterilized swab approximately three times.

3.4       Aseptically break swab off into 5ml phosphate buffer, put the tube on the Cyclo mixer for 10 min.

3.5       Withdraw 1 ml from buffer from (step 3.4) & pour in two Petri dishes having plate count agar (Himedia M0910). Transfer the left over buffer into 10ml of modified lecithin broth (Hi media M 976).         

3.6       Incubate the plates at 32-37 deg. C for 48 hrs.

3.7       Count the number of colonies. It should not exceed 100 cfu

4.0       FREQUENCY: Limits & frequency to be specified by Parent Company.

5.0       RESPONSIBILITY: Executive QA / Executive Production.

6.0       REVIEW GUIDE: Equipment Sanitization log.

6.0         ANNEXURE: --------

7.0         SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x