SOP for Cleaning of Blister Packing Machine

1.0 OBJECTIVE:

To lay down the cleaning procedure for Blister Packing Machine.

2.0 SCOPE:

This SCP shall be applicable for Blister Packing Machine in Packing area in 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 electrical supply.
5.2 Remove the tablets from the hopper, chute, disc & feeder assembly and other parts of the machine. Remove the foil pieces, scrap from cubicle.
5.3 Dismantle hopper, disc, chute, tablet transfer bowl and cover it in polythene bags and transfer to general wash area with “To be cleaned” label.
5.4 Clean the dismantle parts with 2.5 % “Teepol” solution and 15 liter potable water for at least two times. Finally rinse with 15 liter purified Water. Wipe off the parts with dry lint free clean cloth. Finally wipe with 70 % v/v solution of Isopropyl Alcohol (IPA).
5.5 Clean Blister Forming Roller, Blister Sealing Roller & guide tracks with the help of compressed air jet and then wet cloth. Allow the parts to dry.
5.6 After cleaning, cover the change parts in polythene bag with “Cleaned” label and transfer to Tool room or to the respective product cubicle.
5.7 Clean the sealing roller while hot with the help of metal brush and liquid paraffin. Clean the film heater with the help of dry clean lint free cloth after cooling.

5.8 Affix the “Cleaned” label and fill the “Equipment Log Book” .
5.9 Re-cleaned if not used within 72 hours.

6.0 ABBREVIATIONS:

SCP :Standard Cleaning Procedure
IPA :Isopropyl Alcohol

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