SOP for Receipt, Numbering, Usage and Destruction of FBD Filter Bag

1.0 OBJECTIVE

To lay down the procedure for receipt, numbering, usage and destruction of FBD filter bag.

2.0 SCOPE

This SOP shall be applicable for operation of all FBD finger bags in the Production area.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 RECEIPT OF FBD FINGER BAG

5.1.1 Raise the requisition note to purchase department with the required specifications for ordering the new finger bag.
5.1.2 On the receipt of new finger bag from the manufacturer, check the quantity as per delivery challans.
5.1.3 After receiving the finger bag, if found ok record the entry.
5.1.4 Check the intactness of the FBD finger bag visually for physical damage, if any and record the same.
5.1.5 Inform details of damaged finger bag if any, to the purchase department/ manufacturer and return the same.

5.2 NUMBERING OF FBD FINGER BAG

5.2.1 Follow the below-mentioned procedure for numbering of FBD finger bag
5.2.1.1 Number each finger bag as
5.2.1.1.1 FB/100/01

5.2.1.1.2 FB - for finger bag
5.2.1.1.3 100 - for 60 kg capacity FBD.
5.2.1.1.4 01 - for the number of finger bag.
5.2.1.1.5 After receiving new finger bag, number the finger bag serially with a subsequent number as FB/100/01
Note: Number the finger bag after confirming the integrity and record the same in format.

5.3 STORAGE, ISSUE & USAGE OF FBD FINGER BAG

5.3.1 FBD bag should be stored in a polybag and kept into the carets having a lid with “CLEANED” label and maintain a record.
5.3.2 Production person shall issue the numbered FBD bag to the operator when it required and record it in format.
5.3.3 Check the intactness of the FBD bag before and after use and record it in format.
5.3.4 Ensure the cleanliness of the FBD bag both before and after use.
5.3.5 Whenever there is a product changeover, the operator shall return the cleaned and dried FBD bag with proper “CLEANED” status label to the production person.
5.3.6 Use only cleaned and numbered (product/API) dedicated FBD finger bag.
Related: SOP for Tablet Granulation, Compression and Coating

5.4 DESTRUCTION OF FBD FINGER BAG

5.4.1 If the finger bag found damage, torn or defective during use or at the time of receipt should be destroyed.
5.4.2 Before sending the finger bag to scarp yard for destruction, cut the finger bag by using a scissor.
5.4.3 Record the entry of destruction in format.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department

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