SOP for Cleaning of Tablet Compression Machine

1.0 OBJECTIVE:

To lay down the cleaning procedure for Tablet Compression Machine.

2.0 SCOPE:

This SCP shall be applicable for Tablet Compression Machine used in compression area at Production department.

3.0 RESPONSIBILITY:

3.1 Execution :Operator
3.2 Checking :Pharmacist and Above

4.0 ACCOUNTABILITY:

HOD-Production

5.0 PROCEDURE:

5.1 Put “OFF” the electric supply before the cleaning operation and disconnect the supply cable.
5.2 Remove the guard, hopper, feed frame, punches and dies, Wipe off all the surplus powder remaining on the turret. Remove the powder with the help of Vacuum cleaner. Wipe the oil/grease used for lubrication of cam tracks, punches, dies, pressure Rollers with the help of cotton cloth. Clean the other parts with nylon brushes if required.
5.3 Clean the hopper, feed frame and accessories with 25 liter potable water and finally rinse with 25 liter purified water.
5.4 Clean all and other parts mentioned above with 70% v/v solution of Isopropyl Alcohol (IPA).
5.5 Wipe all the parts with clean lint free dry cloth.
5.6 The cleaned machine should be adequately covered.
5.7 All dies & punches after cleaning are to be smeared with food grade oil.
5.8 Fix the “Cleaned” label and fill the “Equipment Log Book”.
5.9 Re-clean if not used within 72 hours.

6.0 ABBREVIATIONS:

SCP :Standard Cleaning Procedure
IPA :Isopropyl Alcohol

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