Handling Power Failure Situation (SOP) in Plant

Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant.

Procedure for Handling of Power Failure in Pharma

1.0   Purpose:Power Failure

    • To lay down a procedure for handling power failure situations.

2.0   Scope:

    • This procedure is applicable to handling power failure situations in the production area, Quality Control, Microbiology, Utility, and Stores at the Pharmaceuticals Drug Manufacturing Plant.

3.0   Responsibility – Handling of Power Failure:

    • Officer/ Executive – Production, Stores, Quality Control, Quality Control (Microbiology) for monitoring and reporting of power failure.
    • Head, Utility, Head– Production, Stores, Quality Control, Quality Control (microbiology). Head-Quality Assurance: for compliance with the procedure.

4.0   Procedure for Handling of Power Failure Situation:

  • Action to be taken in granulation area during power failure for more than 10 minutes:

    • Switch off the power supply to the equipment.
    • Cover the material with a lid / fresh poly bag.
    • After the resumption of power, wait for not less than 20 minutes and checks the following points:
    • Check the temperature and relative humidity of the area.
    • Check air differential pressure of the area.
    • If all environmental parameters are within limit, Switch on the mains of the machines.
    • Check the time elapsed and the required time for completion activity.
    • Check and record the environmental conditions in the respective formats.
  • Action to be taken in the compression area during power failure for more than 10 minutes

    • Unload in-process granules from the hopper into containers and close it properly.
    • Secure the containers to ensure proper storage and integrity of in-process granules and compressed tablets container.
    • After the resumption of power, wait for at least 20 minutes and checks the following points:
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Remove the upper punches.
    • Switch on the power supply to the equipment.
    • Check the direction of rotation of machine in ‘inch’ mode.
    • Ensure that the physical parameters are within the limit.
    • Record environmental conditions.
    • Replace the upper punches and discard the initial two rotation tablets.
    • Check all the in-process parameters as per BMR.
    • Record the downtime in the equipment usage and cleaning log sheet as per reference SOP.
  • Action to be taken in coating area during power failure for more than 10 minutes

    • Take out the gun assembly from the coating pan.
    • After that, Unload the tablets into the in-process container and close the containers properly.
    • After the resumption of power, at least 20 minutes and checks the following points:
    • Check the temperature and relative humidity of the area.
    • Check the air differential pressure of the area.
    • Ensure that the parameters are within the limit.
    • Switch ‘on’ the main of the machine.
    • After getting all the parameters including the coating parameter within the limit, load the tablets into the pan for further processing.
    • Record the environmental conditions in the respective formats.
    • Load the tablets into the coating pan and start coating operation as per BMR.
  • Action to be taken in Inspection area during power failure more than 10 minutes

    • Switch off the Power supply to the equipment.
    • Unload the tablets from the hopper/ inspection belt into a double-lined polybag/ in-process container with a proper status label. Secure the polybag/ in-process container.
    • After the resumption of power, wait for at least 20 minutes and checks the following points.
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Ensure that all the parameters are within the specified limit.
    • Switch ‘on’ the main of the machine.
    • Discard the leftover tablet between two belts.
    • Check and record the environmental conditions in the respective formats.
    • Load the tablets into the hopper and start the inspection activity as per BMR.
  • Action to be taken in the Capsule filling area during power failure more than 10 minutes:

    • Switch off the Power supply to the equipment.
    • Unload the powder/granules from the hopper in the double-lined polybag with proper status label.
    • Remove empty capsule from empty capsule hopper and sorter elevator and put into double polybag lined container or in-process containers and tie the poly bags with the status label. Secure the polybag.
    • Remove filled capsule from capsule polishing machine and put in the polybag and tie it. Label it and secure it.
    • After the resumption of power, wait for at least 20 minutes and checks the following points:
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Ensure that all the parameters are within the specified limit.
    • Switch ‘on’ the main of the machine.
    • After getting the set parameter within the limit, load the powder/granules into the hopper and start the further activity, and record the activity in the respective BMR.
  • Action to be taken in Packing area during power failure for more than 10 minutes

    • Switch off the power supply ‘’ main’’ of the machine (strip/blister/bulk/pouch packing).
    • Unload the contents from the hopper into the double polybag lined container or in-process container with a proper status label.
    • Remove the contents from the feeding box, feeding channel, guide track, and store properly.
    • After the resumption of power, wait for at least 20 minutes and checks the following points:
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Switch ‘on’ the main of the machine.
    • Discard the strips/blisters/sachets under the sealing roller, forming roller of the machine and containers under discharge chute in case of bulk packing.
    • Check the temperature of sealing, and forming sealing roller for blister machine and side sealing for the sachet machine.
    • After getting the set parameter within the specified limit, start the operation as per BMR.
  • Action to be taken in the Sampling & dispensing area during power failure for more than 10 minutes:

    • Switch off the ‘’ main’’ of the machine (RLAF).
    • Stop the sampling & dispensing activities, closed the open container with lid & double lined poly bag.
    • After the resumption of power, wait for 20 minutes and checks the following points.
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Switch ‘on’ the main of the machine (RLAF) and wait for 10 minutes.
    • Restart the sampling and dispensing activities.
    • Make appropriate entries in logs and BMR, as and where applicable
  • Action to be taken in water system during power failure for more than 10 minutes:

    • Switch off the ‘’ main’’ of the system.
    • Avoid the use of water during power failure conditions.
    • After the resumption of power, the following activities shall be done
      • Sanitize the water distribution system as per SOP.
      • After sanitization, water sampling shall be done from all user points of the distribution loop.
      • Based on pH and conductivity, allow using of water for production purposes.
  • Action to be taken in the stability chamber during power failure for more than 24 hour

  • Action to be taken in Sterility and MLT room during power failure for more than 10 minutes:

    • LAF in MLT and sterility area have UPS connectivity.
    • Continue the activity during power failure.
    • For those sterility and MLT areas where UPS is not provided to LAF , switch off the Power supply to LAF.
    • Come out from the room.
    • After the resumption of power, wait for 10 minutes. Carry out environmental monitoring of the concerned area.
    • Repeat the sterility & MLT process.
    • Record the power failure duration time in the respective logbook.
  • Action to be taken in Oral Dry powder filling area during power failure for more than 10 minutes:

    • Switch off the Power supply to equipment.
    • Then Unload the in powder from the hopper.
    • After that Tie the poly bags containing oral dry powder and label it as per the procedure.
    • After resumption of power, wait for 20 minutes and checks the following points.
    • Check the temperature and humidity of the area.
    • Check the air differential pressure of the area.
    • Switch on the power supply to the equipment.
    • Ensure that physical parameters are within the limit.
    • Record environmental conditions.
    • Check all the in-process parameters as per BMR.
    • Record the downtime in the equipment usage and cleaning log sheet.
  • Action to be taken in Dry powder injectable area during power failure for more than 5 minutes:

    • Switch off the Power supply to the equipment.
    • All the activities in the filling area shall be stopped.
    • After the resumption of power, carry out viable and non-viable air particle count in the area.
      • For Class 100:
      • Particle of ³5 m particles/m3 : NMT 3520  
      • Particle of ³0 m particles/ m3 : NMT 29
      • For Class 1000:
      • The particle of ³5 m particles/m3: NMT 35200   
      • The particle of ³0 m particles/ m3: NMT 293
      • For Class 10000:
      • The particle of ³5 m particles/m3: NMT 352000
      • The particle of ³0 m particles/ m3: NMT 2930
    • The limit for viable particle count (By Active air sampling):

      • For Class 100: Less than 1 cfu/plate
      • For Class 1000: NMT 3 cfu/plate
      • Class 10000: NMT 5 cfu/plate
    • Check for the desired differential air pressure.
    • Check the temperature and relative humidity of the area.
    • After the attainment of defined cleanliness in the filling area, carry out local disinfection. Finger dab test shall be taken for operators and recorded.
    • On the basis of non-viable particle count, temperature, RH and differential pressure, completion of sampling for the viable count, start filling activity.
    • In case of any failure in viable particle count and finger dab test (after microbiological testing), the investigation shall be carried out.
    • Re Calibrate all equipment/ instruments after power failure.
    • Store all materials or product in a manner that is in line with material or product storage conditions as defined in specification or BMR
    • Perform the Risk analysis / CAPA as per respective SOPs if required and at the discretion of Head, Quality Assurance.

REFERENCE (S)

    • SOP For Making entries in equipment usage and cleaning log sheet

 

 

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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