SOP for Operation and Cleaning of Tablet Inspection Machine

OBJECTIVE

To provide a procedure for operating and cleaning the Tablet Inspection Machine.

SCOPE

It applies to the operation and cleaning of the 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 the 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.

ALSO READ: SOP for Operation and Cleaning of Tablet/Capsule Counting Machine

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 the tablet inspection machine.
• Feed the tablets to be inspected in the machine hopper.
• 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 the rejection box into a duly labeled high-density polyethylene container.
• When the high-density polyethylene container gets filled at the machine's discharge chute, replace it with another tare duly labeled high-density polyethylene container.
• Remove the container and tighten the bag with a tie band and placed it on a separate trolley.

Shut Down:

• After completion of the operation switch OFF the machine.
• Switch OFF the main electric supply of the machine.
• Transfer the tablets to the respective area.
• Remove the status label from the machine and tear it off and put it 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 a lint-free cloth dipped in purified water.
• Send rinse water sample intimation to IPQA.
• Finally, clean the machine using a lint-free cloth dipped in purified water followed by a dry lint-free cloth.
• Clean the machine body with a dry lint-free cloth.

ABBREVIATIONS

SOP: Standard Operating Procedure.

rpm: Rotations per minute.

No.: Number.

SS: Stainless steel.

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Disposal of Tablets and Capsules after In-Process Checks