SOP on Precautions during power failure in production area

• Objective:To lay down a procedure for precautions during power failure and checks to start the operation.

• Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company.

• Responsibility
  • Production Operator / Production Supervisor / Officer shall be responsible for implementation of this SOP.
  • Head-Production / designee shall be responsible for compliance of this SOP.
• Accountability:
  • Head-Production and Head QA shall be accountable for compliance of this SOP.
• Abbreviations and Definitions:
• PLC – Programmable Logic Control
• Deptt.-Department

• Procedure
  • General Precautions
    • The emergency lights shall ‘ON’ automatically in the department at the time of power failure.
    • Stop any manual manufacturing process, in- process control tests and note down the time.
    • Avoid the transfer of material in the department.
    • Avoid the labeling on any container or any process stage.
    • Stop the weighing of any type of material. Start the weighing process after power resumption.
    • In the following processes, time is the parameter, so note down the time of power failure and power resumption and do the following process for extra time period on power resumption to compensate power failure time.
      • Dry mixing and binding of granules in RMG / FBP.
      • Mixing process using stirrer.
      • Milling process using colloid mill / Comuniting mill.
      • Homogenization using homogenizer.
      • Blending of granules in Blender.
      • Sometimes 3 phase power supply is on but single phase power supply fails, stop all manufacturing processes and in process control tests except the processes.
    • Sifting / Milling and Granulation
      • Switch ‘OFF’ all the equipments of sifting / milling and granulation area and restart them when power restarts.
      • Close the steam valve of FBD to prevent overheating of material.
      • Open the steam valves of Steam pan and FBD after power resumption or as per requirement.
    • Compression
      • Switch ‘OFF’ all the compression machines, de-dusting units, metal detector, dust extract systems and vacuum system.
      • On power resumption, switch ‘ON’ all the above machines and systems.
      • Collect the tablets of first 2 to 3 rotations from the compression machines and keep as non recoverable residual tablets.
      • Check all the parameters of the tablets as per BMR.
    • IPQA test
      • If D.T. test / determination of moisture content / friability test are going on at the time of power failure, stop the process. Take the new sample and repeat the test on power resumption.
    • Coating
      • In case of coaters with PLC,
        • Switch ‘OFF’ the printers. Turn the ‘DOSING’ switch to ‘STOP’ position at main panel board.
        • On power resumption, press the button ‘HOOTER ACK.’
        • Press the button ‘AUTO START’ at main panel board.
        • Turn the ‘DOSING’ switch to ‘START’ position at main panel board.
      • In case of coaters without PLC,
        • Switch ‘OFF’ the machine from panel board.
        • Switch ‘OFF’ the Stirrer and Colloid mill.
        • On power resumption, press the green push button of ‘START’.
        • Press green push button of blower motor.
        • Ensure that atomization air pressure is as per requirement of respective product.
        • Press green push button of pan motor to start the pan rotation.
        • Turn the ‘PERISTALTIC PUMP’ switch to ‘ON’ position at panel board.
        • Switch ‘ON’ the Stirrer and Colloid mill. 

• Inspection
  • Switch ‘OFF’ the Inspection belt.
  • On power resumption, Switch ‘ON’ the Inspection belt.
  • Wait for some time as tube lights flickers on starting and then continue the inspection of product.
• Packaging
  • Stop any manual packaging operation, in-process control tests, weighing of any type of material.
  • Avoid transfer of any type material in the department.
  • Avoid the labeling on any process stage.
  • Switch ‘OFF’ all the Strip, Blister, Labeling machines and Non Filling Detector.
  • Switch ‘OFF’ the filling and sealing machine.
  • On power resumption switch ‘ON’ the machines and start the packaging operations.
  • Start the weighing process after power resumption.
  • Collect the bottles / tubes of initial rotation of machines and reject as non-recoverable.
  • In case of leak test of strip / Blister, stop the leak test apparatus. On power resumption, again perform the leak test with new strip / blister
• Forms & Records

            Nil

• Distribution
  • Master Copy – Documentation Cell (QA)
  • Controlled Copies – Production & Quality Assurance.
• History

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