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SOP for Cleaning of Deblistering Machine

Standard operating procedure to clean Deblistering machine.
2024-04-17T14:38:58Z PrintOnline CoursesQuestion Forum No comments
✔ Technical Review by: | Last Verified:2024-04-17T14:38:58Z

1.0 OBJECTIVE:

To lay down the cleaning procedure for Deblistering machine.

2.0 SCOPE:

This SCP shall be applicable for Deblistering 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 Switch “OFF” the main supply.
5.2 Wipe external surface of the deblistering machine with dry / wet clean lint free cloth until visually clean.
5.3 Clean shaft, blades, SS tray etc with dry / wet lint free cloth.
5.4 Wash with potable water and rinse with purified water.
5.5 Affix ‘Cleaned’ status label indicating the details of the last product.
5.6 Record the details of the activities in the equipment log book.
5.7 Re-clean if not used within 72 hours.

6.0 ABBREVIATION:

SCP :Standard Cleaning Procedure
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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