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
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
|
kg/cm2
|
Kilogram per centimeter
square
|
|
QA
|
Quality assurance
|