SOP for Cleaning of FBD Bag

Standard operating procedure to clean the FBD bag.

1.0 OBJECTIVE:

To lay down the cleaning procedure for FBD Bag.

2.0 SCOPE:

This SCP shall be applicable for FBD Bag in Granulation 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 Shake the FBD Bag properly before removing from Hanger after completion of process.
5.2 Collect the FBD Bag in a polybags and tide it properly with “To be cleaned” label. Then send to washing area.
5.3 Take the potable water in HDPE drum and dip the FBD bag properly.
5.4 Flush the Bag 2 to 3 times by reversing the sleeves.
5.5 Drain the water from the drum and again filled with fresh potable water and add the cleaning agent.
5.6 Flush the bag with fresh potable water till the entire residue washed off.
5.7 Finally rinse with purified water till the entire residue washed off.
5.8 Hang the bag in washing area at least 30 minutes for removal of water.
5.9 Take the bag in a polybags and send to the respective area for drying with “CLEANED” label.
5.10 Dry the bag in FBD and collect it in polybags then tide it properly with “CLEANED” label.
5.11 Store the bag in carats having lid with proper labeling and filled.

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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