1.0 PRE STARTUP
1.1 Visually check the equipment and area for its cleanliness. Ensure that no remnant of previous product / batch is present.1.2 Check the temperature and relative humidity of the area and record the details in the respective log books.
1.3 If the environmental conditions are not within the limit, do not start the operation and inform to the maintenance department.
1.4 If the conditions are within the limit start the operation.
1.5 Ensure the status label on the machine.
1.6 Get the approval from In Process Quality Assurance Officer to start the operation.
2.0 OPERATION
2.1 Switch “ON” the main electric supply of the machine.2.2 Check the machine for any abnormal noise by pushing the start switch button.
2.3 Place the tare polythene lined duly labeled high density polyethylene container below the discharge chute of the machine for collection of inspected tablets.
2.4 Bring the trolley of tablets which is to be inspected near to the tablet inspection machine.
2.5 Feed the tablets to be inspected into the hopper of machine.
2.6 Set the vibration of the vibrator as per the requirement.
2.7 Switch on the conveyor belt.
2.8 Check the tablets for any physical defects.
2.9 Collect the recoverable tablets from rejection box into a duly labeled high density polyethylene container.
2.10 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.
2.11 Remove the container and tighten the bag with tie band and placed on a separate trolley.
3.0 SHUT DOWN
3.1 After completion of operation switch OFF the machine.3.2 Switch OFF the main electric supply of machine.
3.3 Transfer the tablets to the respective area.
3.4 Remove the status label from the machine and tear it off and put in the waste-bin.
3.5 Affix duly filled “TO BE CLEANED” Label on the equipment.
4.0 CLEANING
4.1 Remove the “TO BE CLEANED” Label from the equipment. Tear the label after checking the details on it.4.2 Clean the hopper and conveyor belt using lint free cloth dipped in purified water.
4.3 Send rinse water sample intimation to IPQA.
4.4 Finally clean the machine using lint free cloth dipped in purified water followed by dry lint free cloth.
4.5 Clean the machine body with dry lint free cloth.
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