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SOP for Operation and Cleaning of Tablet Inspection Machine

OBJECTIVE
To provide a procedure for operation and cleaning of Tablet Inspection Machine.

SCOPE
It applies to operation and cleaning of Tablet Inspection Machine.

RESPONSIBILITY
Operator: To operate and clean the machine as per this SOP.
Supervisor: To ensure that the procedure is followed.
Production Manager: To enforce the procedure.

PROCEDURE

Pre-Startup:
  • Visually check the equipment and area for its cleanliness. Ensure that no remnant of previous product / batch is present.
  • Check the temperature and relative humidity of the area and record the details in the respective log books.
  • If the environmental conditions are not within the limit, do not start the operation and inform to the maintenance department.
  • If the conditions are within the limit start the operation.
  • Ensure the status label on the machine.
  • Get the approval from In Process Quality Assurance Officer to start the operation.


Operation:
  • Switch “ON” the main electric supply of the machine.
  • Check the machine for any abnormal noise by pushing the start switch button.
  • Place the tare polythene lined duly labeled high density polyethylene container below the discharge chute of the machine for collection of inspected tablets.
  • Bring the trolley of tablets which is to be inspected near to the tablet inspection machine.
  • Feed the tablets to be inspected into the hopper of machine.
  • Set the vibration of the vibrator as per the requirement.
  • Switch on the conveyor belt.
  • Check the tablets for any physical defects.
  • Collect the recoverable tablets from rejection box into a duly labeled high density polyethylene container.
  • When the high-density polyethylene container gets filled at the discharge chute of machine replace it with another tare duly labeled high density polyethylene container.
  • Remove the container and tighten the bag with tie band and placed on a separate trolley.

Shut Down:
  • After completion of operation switch OFF the machine.
  • Switch OFF the main electric supply of machine.
  • Transfer the tablets to the respective area.
  • Remove the status label from the machine and tear it off and put in the waste-bin.
  • Affix duly filled “TO BE CLEANED” Label on the equipment.

Cleaning:
  • Remove the “TO BE CLEANED” Label from the equipment. Tear the label after checking the details on it.
  • Clean the hopper and conveyor belt using lint free cloth dipped in purified water.
  • Send rinse water sample intimation to IPQA.
  • Finally clean the machine using lint free cloth dipped in purified water followed by dry lint free cloth.
  • Clean the machine body with dry lint free cloth.

ABBREVIATIONS
SOP: Standard Operating Procedure.
rpm: Rotations per minute.
No.: Number.
SS: Stainless steel.

REVISION HISTORY
Nil

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