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SOP for cleaning of FBD bag

SOP for cleaning of FBD bag

Standard Operating Procedure (SOP)

Objective

  • To lay down a procedure for cleaning of FBD bags.

Scope

  • This SOP is applicable for the cleaning of FBD bags in the formulation plant.

Responsibility

    • Production Operator/ Technician – For cleaning of the equipment.
    • Production Officer/ Executive – For checking the cleanliness of the equipment.

Accountability

  • Production Head shall be accountable for the compliance of SOP.

Cleaning Procedure:

    • Before start the cleaning ensure that all the manufacturing operation in the area has been completed.
    • At the end of drying process in FBD.
    • 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 Above step two times more.
    • Finally, rinse the FBD bag again with purified water.
    • Open the drain of IPC container and keep the FBD bag for 20-30 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.
    • Open the polybag and remove the FBD bag and ensure that cleaned FBD bag should not be touched with floors and walls.
    • 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 50-60 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.
    • Transfer the dried FBD bag to storage area with status label “CLEANED”. 

List of Annexure / Format

  • Not Applicable.

References (if any)

  • Instruction Manual.

Reason for revision

  • Periodic Revision.

Abbreviations

  • SOP:   Standard Operating Procedure.
  • B.D. : Fluid Bed Dryer.
  • IR: Infra-Red

END OF SOP

Test requirements & Stability studies as per WHO TRS

 

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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