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SOP on Handling Product During Power Failure

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1.0 Objective: To establish a procedure for handling products during power failures in the production area.

2.0 Scope: This procedure applies to the handling of products during power failures in the production area.

3.0 Responsibility: Officers and Executives in the Production Department are responsible for this procedure. The Production Department Manager also has a role.

SOP on Handling Product During Power Failure

4.0 Definitions: NA

5.0 Procedure:
5.1 Granulation Area:

  • Cover in-process material with lids or polybags.
  • Do not move any material or machines during a power failure.
  • After power resumes, check the temperature, humidity, and air differential pressure of the area.
  • Ensure parameters are within limits.
  • Switch on the machine mains.
  • Check elapsed and required time for drying, mixing, and blending.
  • Allow balances to stabilize before weighing.
  • If the power doesn’t resume within 30 minutes, unload material from the RMG/FBD/vibratory sifter and affix the status label.

5.2 Compression Area:

  • Discard tablets in the de-dusting machine.
  • Cover granule containers, hoppers, and tablets with polybags.
  • After power resumes, check the temperature, humidity, air differential pressure, and rotation direction of the machine in ‘inch’ mode.
  • Allow analytical balance to stabilize.
  • Ensure in-process parameters are within limits before continuous compression.
  • QA certification is required after parameter alignment.
  • If the power doesn’t resume within 30 minutes, unload granules from the hopper and affix the status label.

5.3 Coating Area:

  • Remove the gun assembly from the coating pan.
  • Turn off the machine’s ‘main’.
  • After power resumes, check temperature, humidity, and air differential pressure.
  • Ensure parameters are within limits.
  • Switch on the machine’s ‘main’.
  • Start spraying when the tablet bed reaches a specified temperature.
  • QA certification is required after parameter alignment.
  • If the power doesn’t resume within 30 minutes, unload tablets from the coating pan and affix the status label.

Related: SOP on Making entries in equipment usage and cleaning log sheet

5.4 Inspection Area:

  • Turn off the machine’s ‘main’.
  • If power doesn’t resume within 30 minutes, unload tablets from the hopper and affix the status labels.
  • Remove tablets from the inspection belt.
  • After power resumes, check temperature, humidity, and air differential pressure.
  • Ensure parameters are within limits.
  • Switch on the machine’s ‘main’.
  • Discard leftover tablets between belts and place them in the hopper.

5.5 Packing Area:

  • Turn off the machine’s ‘main’ for strip/blister packing.
  • Cover product containers and hoppers with polybags.
  • If the power doesn’t resume within 30 minutes, unload products from a hopper, feeding box, feeding channel, and guide track.
  • After power resumes, check temperature, humidity, and air differential pressure.
  • Switch on the machine’s ‘main’.
  • Discard strips/blisters/sachets under sealing and forming rollers if the machine stops for more than 2 minutes.
  • Check sealing and forming roller temperatures and set parameters before continuous operation.
  • Perform a leak test before running the machine.
  • Allow check weighing balances to stabilize before weighing.

6.0 Abbreviations:
PLC: Programmable Logical Controller
RMG: Rapid Mixer Granulator
FBD: Fluidized Bed Drier
BMR: Batch Manufacturing Record
SS: Stainless Steel
SOP: Standard Operating Procedure
QA: Quality Assurance

7.0 References:
NA

8.0 Annexures:
None available.

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