SOP for Cleaning of Semi-Automatic Cartoning Machine

Standard operating procedure for cleaning of Semi-Automatic Cartoning Machine for tablet packing in pharmaceutical manufacturing area.

1.0 OBJECTIVE:

To lay down the cleaning procedure for Semi-Automatic Cartoning Machine.

2.0 SCOPE:

This SCP shall be applicable for Semi-Automatic Cartoning Machine in Packing hall 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 Before cleaning stops the machine, Switch “OFF” all the switches and the main switch.
5.2 Switch “OFF” the pneumatic supply.
5.3 Clean the outer and inner surface of cartoning machine with dry / wet clean lint free cloth.
5.4 Clean the inner surface of machine with dry lint free cloth.
5.5 Affix “CLEANED” status label indicating the details of last product.
5.6 Record the details of the activities in the equipment log book.
5.7 Reclean if not used within 72 hours.

6.0 ABBREVIATIONS:

IPA :Isopropyl Alcohol
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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