1.0 PURPOSE: 1.1 To lay down Standard Operating Procedure for storage and movement of unlubricated/graded granules and their transfer to the blender room.
2.0 SCOPE: 2.1 This SOP is applicable to the storage and movement of all unlubricated / grade granules and their transfer to the blender room in the Manufacturing Department of the Pharmaceutical industry.
3.1 Well Trained worker / Operator shall be responsible for the movement of material in the Production Area as per this SOP. 3.2 Officer Production is responsible for the implementation of this SOP.
3.3 Head Production is responsible for ensuring overall compliance with this SOP.
4.1 Storage of Unlubricated / Graded Granules:
4.1.1 Receive the Unlubricated Granules in a closed Conta-bin or in In-process containers in double-lined fresh polybags, along with sifted lubricant in double-lined fresh polybags in HDPE drums.
4.1.2 Ensure that proper Status Label is affixed on Conta Bin or In-process containers of Unlubricated granules and on the HDPE drum containing the sifted lubricant.
4.1.3 Record the inward details of Unlubricated Granules as per Annexure I “Unlubricated Granules movement Record.”
4.2 Procedure for transfer of Unlubricated Granules to Blender Room:
4.2.1 Ensure cleanliness of the Blender Room and its Line Clearance before transferring the Unlubricated granules to the blender room.
4.2.2 Ensure the correct product name and B.No. On unlubricated granules and lubricants to be sifted before transferring it to a blender room.
4.2.3 Transfer the Unlubricated granules and record their outward movement as per Annexure-I “Unlublicated Granules Movement Record.”
PRECAUTIONS: Ensure proper handling of materials during the transfer process. Also, check persons who involve in the materials handling are following the gowning procedure. Properly check the cleanness of the conta bin wheels while transferring them to a blender room.
SOP: Standard operating procedure
HDPE: High-density polyethylene
B.No. Batch Number
IPC: In process container
ANNEXURE-I: Unlublicated Granules Movement Record