SOP on Steps to be taken in case of Environmental Failure

• 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

 

 

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