Standard Operating Procedure for Monitoring of Operational Parameters of Sterile Area

1.         Purpose:-

To maintain environmental conditions within prescribed limit.

To prevent the microbial proliferation.

To Safeguard the product during filling operation

To provide the comfort environment to the operators during filling.

2.         Scope:-

This procedure is followed while maintaining the environmental condition.

3.         Responsibility:-

                        1          HVAC operator

                        2          Microbiologist

                        3.         Incharge Pharmacist

                        4          Sterile Area Operator

4.         Procedure:-

The operational parameters & their limits are as under