- Transfer the required quantity of seals from warehouse to decartoning room on the receipt of the packing material requisition slip.
- Decartoning of Seal
- Decartoning of Rubber Stopper
- Transfer the required quantity of stopper from warehouse to decartoning room on the receipt of the packing material requisition slip.
- The production officer shall verify the Quantity, Analytical Report Number, and Batch Number as per Requisition slip.
- The production officer shall check the issued materials for any physical damage on boxes or bags.
- Clean the outer surface of Box with lint free cloth.
- Open the box and take out the poly bag containing rubber stopper.
- Clean the outer surface of poly bags with a dry lint free cloth.
- Put the status tag on the poly bag and transfer the poly bag containing rubber stoppers to washing and sterilization room for sterilization.
- Decartoning of Primary Packing Material
- Procedure:
- Production Head.
- Accountability
- Officers or above – Production.
- Abbreviations
- SOP: Standard Operating Procedure.
- WFI : Water for Injection
- Responsibility
- This SOP is applicable for Decartoning of primary and secondary packing materials.
- Scope
- To lay down a procedure for Decartoning of primary and secondary packing materials.
- Objective:
- Clean the outer surface of corrugated boxes containing the seals with a lint free cloth. Open the corrugated box and take out the poly bags containing seals.
- Clean the outer surface of the poly bags with a clean lint free cloth.
- Open the poly bags and disinfect the seals by spraying 70% I.P.A. on the seals.
- Close the poly bags with a cable tie and shake for approximately one minute for the uniform distribution of the disinfectant.
- Open the poly bags and transfer the seals to another poly bags
- Close the poly bags containing disinfectant seals, with a cable tie.
- Put the status tag on the bag and transfer the seals through Dynamic Pass Box to the vial sealing room.
- Decartoning of Secondary Packing Materials:
- The warehouse officer to transfer the required quantity of Labels, cartons, pack insert inner Box, shipper boxes and water for injection(WFI) ampoules from warehouse to packing hall as per the packing requisition slip.
- Clean the outer boxes of the Labels, cartons, pack inserts, inner Box, shipper boxes and Water for Injection (WFI) with dry lint free cloth.
- Decarton the corrugated box and take out the Labels, cartons, pack inserts, inner Box, & Water for Injection Ampoules in Plastic Crates & Shipper Boxes in poly bags.
- Put the status tag on it and transfer the Decartoned material to the packing line.
- Dispose of the empty corrugated box and poly bags collected during decartoning.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores,
- History
Date Revision Number Reason for Revision
– 00 New SOP
