STANDARD OPERATING PROCEDURE (SOP)

for
SEIVING WITH RO-TAP SHAKER

Toronto Institute of Pharmaceutical Technology

Department of Pharmaceutical Manufacturing Technology
Code: # MT-13-3-005 Date of issue: 15/09/2013
Written by: Ashish, W; Cherian, V.
Reviewed by: Narinder, K; Niranjani, T. Date of review: 17/09/2013
Authorized by: Shipar, MAH
Objective: To carry out proper sieving procedure of granules according to Good
Manufacturing Practices (GMP).
Scope:
• When: After completion of the granulation.
• Where: Wet Preparation Room
Responsibility: Manufacturing Technician with Supervisor

Precautions:
1. Use proper PPE before entering into the plant
2. Do visual inspection for cleanliness of the room and equipments
3. Keep safe distance from the equipment while in operation
4. Keep the tapping bar of the Ro-tap shaker down all the time to avoid
accidental injury
5. Do proper cleaning after finishing the operation6. Put yellow sign on
wet floor.

Equipment(s):
1. Personal Protective Equipment (PPE)
2. Sieves [according to the Master Manufacturing Instructions (MMI), e.g.
USA Standard Testing Sieve, A.S.T.M. E – 11 Specification, VWR
Scientific, USA., for sieve sizes #10, #14, #16, #18, #20, #30, #40, #50,
#60, #80, etc.]
3. Electronic balance/ Scale (e.g. Precisa Instruments Ltd., Switzerland;
TIPT ID #WS04003)
4. Container (plastic bags), scoops/ spatulas/ spoons, etc.
5. Ro-tap shaker (e.g. W.S. TYLER, USA; TIPT ID # TE97001).

Procedure:
1. Wear proper PPE
2. Fill the Plant Entry Logbook
3. Fill the Production Line Control Logbook for booking the Dispensing
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 Wet Preparation Room and Equipment
7. Collect plastic containers, sieves, scoops/ spatulas/ spoons and
dry granules
8. Fill the Equipment Usage and Cleaning Log Book partially
9. Check if the Scale is validated and labelled
10. Weight each sieve separately and record the weight
11. Arrange the sieves on the Ro-tap shaker followed by increasing sieve
size numbers (according to the MMI), e.g. #10, #14, #16, #18, #20, #30,
etc.
12. Place the pan at the bottom of the sieves
13. Charge the granules to the top sieve (not more than 60%)
14. Place the lid on the top of the “top sieve” Firmly
15. Place the sieves, pan, and lid with granules on the base of the Ro-Tap
Shaker by keeping carefully the tapping bar in the raised position
16. Place the cap and cork on the top holder of the Ro-Tap Shaker and put
carefully the tapping bar down
17. Plug the power cord of the Ro-tap Shaker to the outlet
18. Set the timer between 3 to 5 minutes and start the Ro-Tap Shaker
19. Unplug the power cord of the Ro-Tap Shaker when it stops completely
20. Raise the tapping bar and remove the cap and cork assembly
21. Remove the whole set of sieves and pan
22. Weight each sieve individually to find the amount of granules on each
sieve
23. Put granules of each size in separate container or poly bag
24. If there is any spillage/tailing, record it for reconciliation
25. Clean the Equipment and Room according to the SOP
26. Fill the Equipment Usage and Cleaning Logbook, sign, and counter
signed by Senior Technician

27. Fill the Production Time Control Log

28. Change the status of the Room from Occupied to Vacant
29. Sign out from the plant and exit