1.0 Purpose: To lay down a procedure for the operation of Box Cutting and Vial loading.
2.0 Aim: This Standard Operating Procedure is applicable to the operation of Box Cutting and Vial loading.
3.0 Responsibility:
3.1 Trained operators shall be responsible for Box cutting and vials
3.2 Officers/Sr. Officer for working operation of Box Cutting and Vial loading.
3.3 Manager/ Designee of Production shall be responsible for checking/ training the activity.
3.4 Maintenance Engineer for upkeep and maintenance of the equipment.
3.5 IPQA shall be responsible for enquiring about compliance as per SOP.
3.6 Head/Designee Quality Assurance shall be responsible for the authorization of the SOP.
4.0 Safety considerations:
4.1 Safely remove broken vials.
4.2 Always run the turn table and conveyor belt at optimum speed.
4.3 Personal protective equipment (equipment (Gloves, safety gloves, safety goggles, masks) should be used where ever required.
5.0 Procedure:
5.1 Check the status of box cutting and vial loading.
5.2 Check the status of the turn table.
5.3 Take the line clearance from IPQA.
5.4 Bring the approved and issued Boxes of vials from the Primary packing material store which have to be loaded.
5.5 Prepare the 70 percent IPA solution
5.6 Outer surface of the corrugated boxes should be sanitized by spaying the 70% filtered IPA.
5.7 Cut the boxes with the help of a cutter.
5.8 Take out the corrugated trays of vials and remove the Polythene cover from the trays.
5.9 Load the vials on the loading tray of the turn table.
5.10 Push the Electrical switch “ON” located on the electric board.
5.11 Do Put the Lights of the Loading tray “ON” and Inspect the vials.
5.12 Remove Broken or Cracked vials safely.
5.13 Start the machine by pushing the “ON” switch located at VFD.
5.14 Set the speed of the turn table and Conveyor at optimum.
5.15 Waste and scrap generated during the activity are to be removed as per “Handling of Disposal“.
5.16 After completing the cleaning activity, clean the area as per the “cleaning and sanitization” of the area SOP.
5.17 Do the status Labeling as per the “Status Labeling” procedure.
6.0 Abbreviations:
HOD: Head of the Department
SOP: Standard Operating Procedure
VFP: Vaccine Formulation Plant
PR: Production
70% filtered IPA: 70% Filtered Isopropyl alcohol
VFD: Vacuum flow recount display
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