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Standard Operating Procedure (SOP) for Dry Blending

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STANDARD OPERATING PROCEDURE (SOP)

For
DRY BLENDING
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-13-3-002

Supersedes: Revision 002

Written By: Ashish, W; Cherian, V. Date Written: 10/09/2013 Title: Technician

Reviewed By: Narinder, K; Niranjani, T. Date Reviewed: 11/09/2013 Title: Technologist

Authorised By: Shipar, MAH Date Authorized: 12/09/2013 Title: Supervisor

Purpose: To carry out proper dry blending procedure of granules according to Good

Manufacturing Practices (GMP).

Scope:

When: After dispensing of Active Pharmaceutical Ingredients (API) and Excipients.

Where: Blending room.

Responsibility: Manufacturing Technician with Supervisor.

Material(s): API and Excipients.

Equipment(s):

1. Personal Protective Equipment (PPE)

SOP: Dry blending Shipar, MAH et al.

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2. Twin shell V-blender (e.g. The Patterson – Kelley Co. Inc., USA; TIPT ID #

PE95002).

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. Do not fill more than 60% of the V-blender with the ingredients

4. Keep safe distance from the equipment while in operation

5. Bring up the dispensing port of the V-blender during collecting the mix into the

container.

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 powders from in-process storage (already dispensed according to the Master

Formula Working Record [MFWR])

SOP: Dry blending Shipar, MAH et al.

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10. Plug the power cord of the V-blender to the outlet and check the machine working

with agitation bar; then, unplug the power cord.

11. Attach the dispensing port

12. Fix the agitation port

13. Attach one of the charging ports

14. Transfer the powders from the container into the blender accordingly (e.g. excipient,

API, excipient; or API, excipient, API [if there are two API])

15. Attach the second charging port

16. Plug the power cord of the V-blender to the outlet again to start the machine, and

then, start the agitation

17. Continue the blending until the time specified in the Master Manufacturing

Instructions (MMI)

18. Unplug the power cord of the V-blender

19. Collect the dry blending mix in the container by opening the dispensing port

20. Dismantle the charging ports and agitation port from the blender

21. Collect spillage/tailing and record it for reconciliation

22. Place the dry blending mix with the required label in in-process storage

23. Clean the Equipment and Room according to the SOP

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.

SOP: Dry blending Shipar, MAH et al.

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Figure 1: Twin shell V-blender (The Patterson – Kelley Co. Inc., USA; TIPT ID # PE95002).

Figure 2: Agitator

SOP: Dry blending Shipar, MAH et al.

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