sop on Handling of FBD bag
Objective:To lay down a procedure for handling of FBD bag.
Scope:This SOP is applicable receipt, issuance, usage cleaning and retrieval of F.B.D Bag to the formulation plant of (Pharmaceutical Company Name).
Responsibility
Operator/ Technician of production shall be responsible for issuance, usage, cleaning and retrieval of FBD bag.
Production and QA Officer/Executive shall be responsible for implementation of the SOP.
Accountability
Production and QA Head shall be accountable for compliance of SOP.
Abbreviations and Definitions
SOP :Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
PD:Production
No.:Number
FBD:Fluidized Bed Dryer
Procedure
Procedure for cleaning and storage of FBD bag
Cleaning of FBD bag shall be performed after every usage of the FBD bag
Before start the cleaning ensure that all the manufacturing operation in the area has been completed.
At the end of drying process in FBD, allow the FBD bag to
Remove the FBD finger bag from the hooks.
Fold the FBD bag and make it compact as per size of polybag.
Put the FBD bag in the polybag and close the polybag.
Affix the status label “TO BE CLEANED” on the polybag.
Transfer the FBD contained polybag to washing area.
Open the polybag and place the FBD bag in the IPC bin.
Fill the IPC bin with purified water above the FBD bag and ensure that FBD bag is fully dipped in the water.
Manually wash the FBD bag and drain the water used for washing.
Repeat the same process two times again.
Finally rinse the FBD bag again with purified water.
Open the drain of IPC container and keep the FBD bag for 25-30 minutes.
Fold the FBD bag and put in the cleaned polybag.
Affix the status label “CLEANED” on the polybag.
Transfer the FBD contained polybag to processing area and ensure that FBD is cleaned.
Hang the FBD bag in the hooks provided and integrate the FBD bowl.
Dry the FBD bag with dry heat air at temperature 35°C – 40°C for 60 minutes.
Check the FBD for dryness, if not dried again allow the dry heat air for few minutes.
After complete drying, remove the FBD bag from hooks and fold it and put in the cleaned polybag.
Ensure that FBD bag storage area is clean and free from dust and foreign particles.
Transfer the dried FBD bag to storage area with status label “CLEANED”.
Procedure for Issuance of FBD bags
At the time of requirement, Issue the product specific FBD bag from its storage area.
Ensure that FBD bag is cleaned.
IPQA personnel shall check the issuance of correct product specific FBD bag.
Production and IPQA personnel shall check the integrity of the FBD bag and shall
Ensure that there is no leakage in the FBD Bag.
Record the Issuance of FBD bag in the annexure of this SOP.
Before transfer of the FBD bag, ensure that processing area is cleaned and line clearance has been taken to start the operation.
Bring the FBD Bag to processing area
Procedure for Usage of FBD Bag
Wear the hand gloves before assembling the FBD bag with the FBD.
Assemble the FBD bag on the ring and hooks provided.
After assembling of the FBD bag, integrate the FBD bowl with the FBD.
Start the operation of FBD as per SOP.
After Completion of the FBD operation, Shake the FBD bag in manual mode of FBD operation
Unlock the FBD bowl and remove it aside.
Manually remove the FBD bag from the ring and it`s hooks
Affix the status label “TO BE CLEANED” and transfer to cleaning and washing area.
Procedure for Retrieval of FBD Bag
After completion of cleaning and drying of the FBD bag, transfer the FBD bag to it`s respective storage area.
Ensure that storage area is cleaned and free from dust and foreign particles.
Production and IPQA personnel check the integrity and cleanliness of FBD Bag and stored it in lock & keys.
Record the Retrieval of the FBD bag to in the format.
Procedure for Issuance of the new FBD Bag
Production officer/Executive shall raise the material issuance request to issue the new FBD bag.
Engineering store personnel shall issue the new FBD bag
Production personnel shall receive the new FBD bag and shall check the correctness of FBD bag against PO specifications.
Before use of the new FBD bag, handle the new FBD Bag as mentioned in steps 6.2, 6.3 and 6.4.
List of Annexure / Format
Issuance, usage, Cleaning and retrieval of FBD Bag-Annexure-I.
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production.
For More Pharma Updates Visit –https://pharmaguidances.com
