Procedure for Operation of Rotary Wet Granulator

1. OBJECTIVE
To lay down the procedure for rotary wet granulator

2. SCOPE
This procedure is applicable to Production, in the granulation area of Tablet section

3. RESPONSIBILITY
• Supervisor/ Machine Operator
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• Normal electrical precautions should be followed.
• Gloves, eye and ear protection are required.
• While loading and unloading use hand gloves

5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.3 Before starting the operation production person get the line clearance from Q.A person and affix the status label with product name, batch details to equipment & area.
5.4 Put ‘ON’ the mains of the machine.
5.5 Fix the required sieve on the granulator.
5.6 Load the Granulator with Wet mass and switch on the supply.
5.7 Collect the Wet Granules in the tray.
5.8 Collect the Wet Granules open the sieve and remove the remaining mass from the blades of chopper with scraper.
5.9 Put “OFF” the mains after completion of operation.
5.10 Affix ‘To be Cleaned’ label
5.11 Fill the “Machine Usage Log Book”.

6. RELATED DOCUMENTS
Machine Usage Log Book – Annex. I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance
SOP Standard Operating Procedure

9. REVISION HISTORY