SOP for Issuing, Cleaning, Storage and Destruction of FBD Bags

OBJECTIVE

To lay down procedures for Issuing, cleaning, storage and destruction of FBD bags.

SCOPE

This applies to all the bags used in all FBD machines at XYZ Ltd.

RESPONSIBILITY

Operators: Clean the bags after use as per the procedure mentioned.

Supervisor: To issue, store, and retrieve the FBD bags as per this procedure and ensure that the procedure of cleaning is appropriately done.

IPQC: To verify the cleaning, issuing, and retrieval of FBD bags. To advise destruction of FBD bags once deemed not fit for use.

QA Manager: To facilitate the destruction of FBD bags once deemed not fit for use.

PROCEDURE

(Note: Preferably, each bag should be dedicated to a specific product)

Issuing:

• Issue the FBD bag to the operator according to the type of FBD machine in which it is to be used.
• Issue FBD bag according to the product to be run on the FBD machine.
• Production Supervisor and IPQA personnel to check the integrity of FBD bag before issuing, to avoid the possibility of any leakages in the bags during the drying operation.

• Record the details in the issuing log book, as per the format mentioned in Annexure-1

ALSO READ: SOP for Operation and Cleaning of Fluidized Bed Dryer

Cleaning

• Ensure that all manufacturing operations are completed in the area before dismantling the FBD bags from the machine.
• Remove the FBD bags from the hooks.
• Put the FBD bags in a polybag. Affix the label ‘To be cleaned’ on the polybag and transfer to the Granulation washing area.
• Wash the FBD bags with potable water.
• If required dip FBD Bags in 1 % soap solution and allow to soak to remove adhered material.
• Rinse with potable water to remove the soap, if any.
• Make the final rinse with purified water.
• Squeeze to get rid of water.
• Allow water to drip for 20/30 minutes by hanging on the hanger / in the drum.
• Fold the FBD bag and put it in the cleaned polybag. Affix the label ‘Cleaned’ on the polybag.
• Transfer the FBD-contained bag to the processing area and ensure that the FBD machine is cleaned. Dry it in the FBD at 60°C for at least 30 minutes.
• Check the FBD bags for dryness. If not dried, allow drying again for a few minutes, until completely dry.
• After complete drying, remove the FBD bags from the hooks and fold it and put in the cleaned polybag. Affix the Status label ‘CLEANED’ on the polybag.
• Return FBD bag to supervisor for storage.

Frequency of cleaning:

• Once after 3 batches, in case of batch change-over
• At every product change-over.

Storage

• Ensure that the cleaned/dried FBD bags are kept in appropriately labeled (i.e. “CLEANED”) polybags.
• Transfer the cleaned/dried FBD bags with the ‘cleaned’ label to the FBD bag storage area.
• Store the FBD bags in the designated places in the Storage area.

Destruction

• Destruction of the bag to be done in the following cases:

1. if the bag got a hole or cut that cannot be repaired
2. if the bag is damaged to the extent deemed “not fit for use” by Authorized personnel.

• Take authorization in Annexure-2 before the destruction
• Fill bag destruction record as per Annexure-2.

ABBREVIATIONS

FBD: Fluid Bed Drier

PF: Purified Water

IPQC / IPQA: In-process Quality Control / In-process Quality Assurance

QA: Quality Assurance

ANNEXURE

REVISION HISTORY

Nil

ALSO READ: Working Principle and Applications of FBD (Fluid Bed Dryer)