1. OBJECTIVE
To lay down the procedure to Silver-son homogenizer with 500 liter mixing tank to reduce the particles and disperse throughout a fluid and to make uniform in consistency.
2. SCOPE
This procedure is applicable to Production, in the mixing area of syrup 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 Deionized water is transferred through pump to in the tank
5.6 Load the measured quantity of the mixture into the 500 liter mixing tank as per batch manufacturing record.
5.7 Ensure that the condition for your mixture is appropriate.
5.8 Press the green button of board attached to tank for rotation of paddles as in side syrup tank there are paddles which rotate at the variable speed
5.9 Give the proper time of mixing as per batch manufacturing record
5.10 Press the red Button to stop the paddle rotation after completion of process
5.11 After thorough mixing syrup is transferred to SS storage tank
5.12 Send the Sampling request to Quality control department
5.13 After released from QC department, Tank is attached to filling line for transferring syrup to filling machine
5.14 Put Off the mains after completion of operation
5.15 Affix ‘To BE CLEANED’ status label
5.16 And fill the equipment log book
6. RELATED DOCUMENTS
Equipment Usage Log Book – Annex. I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Production Department | 01 | , |
8. ABBREVIATIONS
SS Stainless Steel
SOP Standard Operating Procedure
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 06/09/2022 | 00 N/A | First Version |