- Objective
- To lay down the steps to be taken in case of environment failure in the aseptic area of Sterile Dry Powder Injectables facility.
- Scopе
- This SOP describes the steps to be taken in case of environmental failure.
- Responsibility
- Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP.
- Accountability
- Production Head and QA Head shall be accountable for the compliance of SOP.
- Abbreviations
- BMS : Building Management System
- NLT : Not less than
- NMT : Not more than
- BMR : Batch manufacturing record
- IPA : Iso propyl alcohol
- 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 BMR.
- Note the temperature with the help of Standard mercury in glass thermometer.
- If the temperature is in acceptable limit of NLT 25ºC, carry on with the Production activities.
- If the temperature is outside the limits immediately stop the production till desired temperature is obtained.
- Note the Relative humidity with the help of Digital hygrometer /Sling hygrometer.
- If the Relative humidity is in acceptable limit of NMT 30%, carry on with the Production activities.
- If the Relative humidity is outside the limits immediately stop the production till 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.
- 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.
- 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 bags of rubber stoppers and send for re-sterilization.
- Sanitize the entire area as per schedule.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP