ENVIRONMENTAL FAILURE (STEPS TO BE TAKEN IN CASE)
PURPOSE: To lay down a procedure for steps to be taken in case of environmental failure.
SCOPE: This SOP is applicable for steps to be taken in case of environmental failure in Dry Powder Injection section.
RESPONSIBILITY:
Preparation of SOPs: Officer/ Executive of Production Departments
Checking and Review of the SOPs: Next Level of the Production Department
Approval of the SOPs : Head of Production Department
Authorizing of SOP: Head of QA Department.
Officer/Executive of Production Department shall responsible for the procedure has been followed as per this SOP.
IPQA person shall responsible for the Compliance of the procedure as followed by this SOP.
ACCOUNTABILITY: The Production Head shall accountable for implementation and Head QA shall accountable for compliance of the SOP.
PROCEDURE:
Steps to be taken in case of failure of Building Management System:
In case of BMS failure observe the critical parameters (Temperature, Relative humidity) on Hourly basis and note the observations in the BPR.
Note the temperature with the help of Digital hygrometer.
If the temperature is acceptable limit as per the area requirement, carry on with the Production activities.
If the temperature is outside the limits immediately stop the production until desired temperature is obtained.
Note the Relative humidity with the help of Digital hygrometer.
If the Relative humidity is in acceptable limit as per the area requirement, carry on with the Production activities.
If the Relative humidity is outside the limits immediately stop the production until desired level is maintained.
Steps to be taken in case of Power failure:
Immediately leave the filling room and come to the sterile corridor whenever there is power failure.
If the power failure is within 5 minutes:
Enter the filling room and sanitize the hands with 70% IPA.
Remove the vials (empty and filled vials without stoppers) from the filling line with help of sterile forceps.
Start the outfeed turntable and allow the stoppered vials to move to sealing area.
Remove the remaining stoppers from the hopper and the chute.
Spray the entire area with 70% IPA.
Resume the production activities after spraying is completed.
If the power failure is more than 5 minutes:
Cancel the production activities for the day.
Enter the filling room and sanitize the hands with 70% IPA.
Remove all the vials (empty, filled) from the filling line with the help of sterile forceps.
Collect the remaining stoppers from the hopper/chute and send for re-sterilization.
Dismantle the machine parts and reject the remaining raw material in the hoppers.
Send the machine parts for sterilization.
Remove the unused rubber stoppers and send for re-sterilization.
Sanitize the entire area as per schedule.
Enter the necessary entry into the particular equipment logbook.
REFRENCES: SOP ON SOP