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Standard Operating Procedure (SOP) for Cleaning, Handling, and Storage of Fluid Bed Dryer FBD Bags for a different group of the drug product in the pharma plant. 

Procedure for Cleaning, Handling, and Storage of FBD Bags

1.0   PURPOSE:

• • The purpose of this SOP is to define the cleaning, handling, and storage of FBD bags.

2.0   SCOPE:

• • This procedure is applicable for the cleaning, handling, and storage of all FBD bags of different groups of products at the pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • In House

4.0   RESPONSIBILITY- SOP OF FBD BAGS:

• • The operator shall be responsible for Cleaning and Storage of the FBD bags as per the defined procedure.

• • The production Supervisor shall ensure the cleaning and storage of the FBD bags as per the defined procedure.

Visit to copy this SOP

• • The production Supervisor shall ensure the numbering of the FBD bags.

• • Officer / Chemist of the production department shall arrange for the destruction of damaged FBD bags.

• • Production Supervisor shall provide training to the new operators before involving in operation and maintain all necessary records.

• • Department Head/Designee shall be responsible for the follow-up and review of the SOP.

• • Quality Assurance shall ensure proper usages of the FBD bags before use and to authorize the destruction of damaged FBD bags.

• • Maintenance shall arrange for the destruction of damaged FBD bags.

• • Quality Head shall be responsible for the Compliance and approval of the SOP.

5.0   ABBREVIATIONS USED IN SOP OF FBD BAGS:

• • BMR: Batch Manufacturing Record

• • Dept: Department

• • NA: Not Applicable

• • NLT: Not Less Than

• • PO: Purchase Order

• • QA: Quality Assurance

• • SOP: Standard Operating Procedure

• • FBD: Fluid Bed Dryer

• • DEFINITION: NA

6.0   PROCEDURE – HANDLING, STORAGE, AND CLEANING OF FBD BAGS:

• • FBD Bags cleaning procedure after use:

  • Batch to Batch Cleaning:

• • • Remove the adhere powder from FBD bags by manually shaking.

• • • Lower FBD bag holding ring and check the bag for its integrity and intactness.

Note: The cleaned FBD bag remains valid for 48 hours, if the bag is not used within 48 hours, then it should be cleaned before use as per below cleaning procedure.

• • Cleaning procedure during a changeover:

  • Remove the adhered powder from FBD bags by manually shaking.

• • Remove the bag from FBD and reverse the FBD bag sleeves manually and then tap gently for 2 – 3 times.

• • Wash the bag with running potable water for 10 minutes for 150 kg Capacity FBD bag, and NLT 15 minutes for 250 kg capacity FBD bags, and NLT 20 minutes for 400 kg capacity FBD bag inside and outside of the bags.

• • Clean the FBD bag with a 2.0 % non-ionic detergent solution using nylon scrubber.

• • Rinse the FBD bag of 150 kg capacity with running potable water for NLT 10 minutes. and for 250 kg capacity FBD bag with running potable water for NLT 15 minutes and for 400 kg capacity FBD bag rinse with potable water for NLT 20 minutes.

Related: SOP for Batch Size Determination

• • Finally rinse the 150 kg capacity FBD bag with purified water for NLT 5 minutes, 250 kg capacity FBD bag with purified water for 10 minutes and 400 kg capacity FBD bag with purified water for NLT 15 minute.

• • Ensure the cleanliness of the FBD bag, if not, then re-clean as per the above steps.

• • Forward the sleeves of the FBD bag manually.

• • Then attach the FBD bag in cleaned FBD chamber & dry it at a temperature of 60ºC for about one hour.

Note: The cleaned FBD bag remains valid for 48 hours, if the bag is not used within 48 hours, then it should be cleaned before use as per the above cleaning procedure.

• • FBD Bag Cleaning Procedure before use:

  • Take the FBD bags as per the requirement of the product from its dedicated duly labeled container.

• • Ensure the cleaning validity of FBD bags.

• • Wash the FBD bag as per above, from step mentioned under “Cleaning procedure during a changeover”

• • Dry the bag in FBD and ensure complete drying of it.

• • After completion of the drying of the bag, the product can be dried.

• • Handling and Storage of FBD Bags:

• • Remove the bag from FBD after completion of the drying process.

• • Ensure the complete dryness of the FBD bag.

• • Visually check the intactness of the FBD bag (any damage or defects) before and after use.

• • Keep the bag in a polyethylene bag and affix duly signed Cleaned label with product name for which it is
  • used.

• • Keep this labeled bag in its dedicated container, labeled with Product name.

• • Close the container lid properly.

• • The issuance, return and cleaning of FBD bag to be recorded in the FBD bag utilization register. (Annexure-1)

• • Handling of new FBD bag:

• • Check the newly received FBD bag against challan.

• • Certificate received from the external party of the newly received FBD bag shall be verified by the Engineering head and Production head or designee.

• • Check the no of sleeves as per FBD.

• • Check the intactness of the newly received FBD bag.

• • Record spot observation in the FBD bag receipt checklist as per Attachment-3.

• • If any rupture or damage observed at the time of receipt, the FBD bag shall be rejected and returned to the supplier.

• • Allocate the code no of newly received FBD bag as FBD-capacity/ No. of finger/ serial no. For Example, FBD 250 kg having 19 fingers then FBD bag no. will be ‘FBD-250/19/001’ for the first bag for FBD 250 kg. 1st FBD bag of 400 kg capacity having 37 no. of the finger then FBD bag no. will be FBD-400/37/001 and enter in FBD bag inventory register as per Annexure-2

• • Inventory register to be maintained on every first week of every month.

• • Clean the newly received FBD bags as per product to product cleaning procedure and to be recorded in the FBD bag utilization register (Annexure-1).

• • Destruction of FBD bag:

• • Destroy the FBD bag after 8 years of completion of usage or found any defect, whichever is earlier.

• • But after completion of 5 years, the bag shall be re-inspected for its physical intactness and if found satisfactory FBD bag shall be used for further 3 years after taking approval from production head and Q.A. Head or Designee (As per Annexure-5)

• • Then destroy the bags by cutting into pieces by scissors after taking disposal approval from the department head and QA in “Disposal Record for FBD bag” and then hand over to the maintenance dept. or send to scrap yard for disposal.

• • The user department shall assign Disposal record number as 00X.

• • Where X is the serial number. (Example: Very first damaged FBD disposal record number shall be assigned as 001 then followed by 002, 003…..)

• • The disposal details shall be recorded in the FBD bag Inventory register (Annexure-2).

7.0   ANNEXURES:

Annexure 1: FBD Bag Utilization Register

Create the Utilization Register / Log with following table contents

• • FBD Bag Code No.

• • Issue Date

• • Issued by

• • Product name

• • Batch No.

• • Cleaned by

• • Checked by

• • Returned By

• • Returned Date

• • Weight after drying

• • Remarks

Annexure 2: FBD Bag Inventory Register

Annexure 3: FBD Bag Receipt Check List

Annexure 4: Disposal Record for FBD Bag

Annexure 5: FBD Bag Re-inspection Check List