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.
PEOPLE ALSO READ: SOP for Operating Procedure of Auto Dust Extractor
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
PEOPLE ALSO READ: SOP for Operation and Cleaning of Turn Table
0 Comments