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Handling of FBD bag

  • 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.

  • History:
Date Revision Number
Reason for Revision
00
New SOP

 Annexure-I

                                Issuance, Usage, Cleaning and Retrieval of FBD bag

Date Issued to Product B. No. Issued

By

Received

By

Usage Time Cleaning Cleaning Done By Cleaning Checked By Retrieval Date Retrieved By
From To From To

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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