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

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

SCOPE
Applies to all the bags used in the all FBD machines at XYZ Ltd.

RESPONSIBILITY
Operators: To clean the bags after use as per the mentioned procedure.
Supervisor: To issue, store, retrieve the FBD bags as per this procedure and ensure that the procedure of cleaning is appropriately done.
IPQC: To verify the cleaning, issuing, retrieval of FBD bags. To advise destruction of FBD bags once deemed not fit for use.
QA Manager: To facilitate 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 possibility of any leakages in the bags during the drying operation.
  • Record the details in the issuing log book, as per format mentioned in Annexure-1

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 get rid of adhered material.
  • Rinse with potable water to remove the soap, if any.
  • Make 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 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 to dry again for few minutes, until completely dry.
  • After complete drying, remove the FBD bags from 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 labelled (i.e. “CLEANED”) polybags.
  • Transfer the cleaned / dried FBD bags with ‘cleaned’ label in 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 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 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

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