Reviewed By: Narinder, K; Niranjani, T. Date Reviewed: 07/09/2013 Title: Technologist ... the time mentioned in Master Manufacturing Instruction (MMI). 16.
Page 1 of 4 STANDARD OPERATING PROCEDURE (SOP) For LOW SHEAR WET MASSING/ WET GRANULATION Prepared by: Shipar, M.A.H.; Ashish, W; Cherian, V; Narinder, K; Niranjani, T. Department of Pharmaceutical Manufacturing Technology Toronto Institute of Pharmaceutical Technology
SOP # MT-13-3-006 Supersedes: Revision 003 Written By: Ashish, W; Cherian, V.
Date Written: 06/09/2013
Reviewed By: Narinder, K; Niranjani, T. Date Reviewed: 07/09/2013 Authorised By: Shipar, MAH
Title: Technician Title: Technologist
Date Authorized: 09/09/2013 Title: Supervisor
Purpose: To carry out Wet Massing/ Wet Granulation by low Share according to Good Manufacturing Practices (GMP). Scope: Why: To get homogenous wet mass for wet screening. When: After Dry Blending and Binder Solution preparation. Where: Wet Massing Room. Responsibility: Manufacturing Technician with Supervisor. Material(s): Dry Blend, Binder Solution, De-ionized Water (if needed).
SOP: Low Shear Wet Massing/ Granulation
Shipar, MAH et al.
Page 2 of 4 Equipment(s): 1. Personal Protective Equipment (PPE) 2. Hobart Low Share Planetary Granulator (e.g. TIPT ID # PE9600). 3. Container (plastic bags), scoops/ spatulas/ spoons, etc. Precautions: 1. Use proper PPE before entering into the plant 2. Do visual inspection for cleanliness of the room and equipments 3. 4. Keep safe distance from the equipment while in operation 4. Do not put hand inside the bowl when the whisk of the Granulator is in rotation 5. Make sure the space between the bowl and the whisk is sufficient to rotate without any friction (at least 2mm space is required). Procedure: 1. Wear proper PPE 2. Fill the Plant Entry Log Book 3. Fill the Production Line Control Log Book for booking the Blending Room 4. Check differential pressure (above 5 Pascal), temperature (≈ 25°C) and humidity (≈20%) of the wet preparation room 5. Change the room status from Vacant to Occupied 6. Do visual inspection of the Blending Room and Equipment 7. Collect plastic containers, sieves, scoops/ spatulas/ spoons, etc. 8. Fill the Equipment Usage and Cleaning Log Book partially 9. Bring the Dry Blend and Binder Solution from in-process storage 10. Weigh the whisk and bowl and record the weight in Wet Massing Log Book
SOP: Low Shear Wet Massing/ Granulation
Shipar, MAH et al.
Page 3 of 4 11. Fix the Bowl and the Whisk to the Granulator 12. Transfer the Dry Blend Powder into the Bowl 13. Adjust the Bowl and Whisk to keep at least 2mm gap 14. Plug the power cord of the Hobart Planetary Granulator to the outlet and check the machine working properly 15. Adjust the speed of the Granulator to 1 (minimum speed) and run the machine up to the time mentioned in Master Manufacturing Instruction (MMI) 16. Then, increase the speed to 2 17. Add Binder Solution to the powder of the Bowl gradually by spraying in accordance with the MMI 18. Then, stop the machine and scratch the bowl with spoon/spatula to avoid collection of powder/particle on the base of the Bowl and start it again to continue mixing 19. After the time required by the MMI, stop the machine and conduct the Squeeze Test to check the End Point of the Wet Massing. If the End Point is reached, stop the machine. Otherwise, continue mixing and redo the Squeeze Test until the End Point is reached. 20. Then, unplug the machine 21. Remove the Whisk of the Granulator 21. Remove the Bowl 22. Transfer the Wet Mass from the Bowl into a labelled container and put it in-process storage 23. Collect spillage/tailing and record it for reconciliation 24. Clean the Equipment and Room according to the SOP
SOP: Low Shear Wet Massing/ Granulation
Shipar, MAH et al.
Page 4 of 4 24. Fill the Equipment Usage and Cleaning Log Look, sign, and counter signed by Senior Technician 25. Fill the Production Time Control Log 26. Change the status of the Room from Occupied to Vacant 27. Sign out from the plant and exit.
Figure: Hobart Low Share Planetary Granulator (TIPT ID # PE9600). SOP: Low Shear Wet Massing/ Granulation
Shipar, MAH et al.
