Silver Homogenizer operation SOP

1.0 OBJECTIVE:

To lay down the operation procedure for Silverson homogenizer with 500 liter mixing tank to reduce the particles and disperse throughout a fluid and to make uniform in consistency.

2.0 SCOPE:

This SOP shall be applicable for the operation of Silverson homogenizer with 500 liter mixing tank used in mixing area of Syrup Section in Production department.

3.0 RESPONSIBILITY:

3.1 Supervisor/ Machine Operator.

3.2 Production Pharmacist & above.

4.0 ACCOUNTABILITY:

4.1 Manager-Production department.

5.0 MATERIAL AND EQUIPMENT:

5.1 Silverson homogenizer.

5.2 500 liter mixing tank.

6.0 PROCEDURE:

6.1 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.

6.2 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.

6.3 Put ‘ON’ the mains of the machine.

6.4 Load the measured quantity of the mixture into the 500 liter mixing tank as per batch manufacturing record.

6.5 Ensure that the condition for your mixture is appropriate.

6.6 Maximum and minimum volumes for the unit should be followed at all times.

Maximum _______________

Minimum _______________

6.7 Consider the appropriate mixture-to-solvent ratio.

6.8 Mixture should be approximately the same size as the generator diameter. Some initial fragmentation may be required to achieve this.

6.9 It may be preferable to run the motor in short burst (~15 seconds) rather than for an extended time.

6.10 Put ‘OFF’ the mains after completion of operation.

6.11 Affix ‘To be Cleaned’ status label.

6.12 And fill the ‘Equipment Log Book’.

6.13 Precautions:

6.13.1 Normal electrical precautions should be followed.

6.13.2 Gloves, eye and ear protection are required.

6.13.3 While loading and unloading use hand gloves.

7.0 REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

8.0 REFERENCES:

8.1 Not Applicable.

9.0 ANNEXURES:

9.1 Not Applicable.

10.0 ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
PM	Production machinery
PM_O	Production machinery operation
F	Format
kg/cm²	Kilogram per centimeter square
QA	Quality assurance