STANDARD OPERATING PROCEDURE EVALUATION OF ENVIRONMENTAL COUNT

STANDARD OPERATING PROCEDURE

SUBJECT:

EVALUATION OF ENVIRONMENTAL COUNT

DEPARTMENT : QA

SOP NO. :

Page No :

Effective Date :

Next Review :

SOP REVISION :

1.0 OBJECTIVE:

To provide guidelines for Air borne Micro Organisms in Mfg., Filling and Packing areas of Liquid department and in microbiological lab.

2.0 POLICY:

To lay down a procedure for evaluation of environmental count.

3.0 PROCEDURE:

3.1 Aseptically dispense sterilized Letheen agar modified in sterile petri plates. Incase

of environmental bioburden evaluation of P&G making and packing areas the methodology adopted is as per P&G SOP.

3.2 Pre-incubate the plates at 20-25^OC/for five days 30-35^OC for 3 days respectively before use.

3.3 Observe the plates after incubation; if any growth is observed, discard the plate.

3.4 Expose above mentioned contamination free plates in various locations for a period of 30min.

3.4.1 LOCATION OF EXPOSURE:

3.4.1.1 Cream department

3.4.1.2 Cream manufacturing and filling department

3.4.1.3 Cream Packing department

3.4.1.4 Abbott Area,Mintop area,Gelusil area, Folvite area.

3.5 Incubate the exposed plates at 20- 25^OC/for five days & 30 - 35^OC for 3 days.

3.6 Incubate an unexposed plate as negative control for each batch of plates used for

Environmental monitoring.

3.7 At the end of the incubation period, examine each plate for growth of micro- organisms

and record the results.

3.8 Evaluation of environmental monitoring will not be conducted whenever any maintenance

works are in progress in the departments and during power failures..

1.0 FREQUENCY: Limits & Frequency to be provided by Parent Company.

5.0 RESPONSIBILITY: G.M (Q.A) / Microbiologist.

6.0 REVIEW GUIDE: Environmental logbook.

7.0 ANNEXURE: 1.Evaluation of environmental count.

8.0 SOPs DISTRIBUTION:

This SOP shall be distributed to following Departments:

ANANYA PHARMA JOBS