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| Homogenizer |
SOP For Homogenizer
Standard Operating
Procedure for Homogenizer.
1.0 Purpose
The purpose of this
SOP is to develop a standard procedure for operating the Mixing Homogenizer.
2.0 Scope
This SOP is applicable
for the Mixing Homogenizer used in the granulation area for binder preparation,
in the coating area for preparation of coating suspension & in the liquid
manufacturing area of the production section
3.0 Responsibility
3.1 Machine Operator
is responsible for operating the Homogenizer.
3.2 Production
Pharmacist is responsible for the implementation of this Standard Operating
Procedure.
3.3 The HOP is
responsible for ensuring the implementation of the current SOP.
3.4 Quality Assurance
Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Relevant area
Pharmacist shall ensure that the Homogenizer
& the area
is properly cleaned.
4.2 Production
Pharmacist shall ensure that the line clearance is awarded &
product-related labels are attached to the equipment & area.
4.3 Ensure that air
pipes are connected to the specific connectors of the homogenizer for lifting
the homogenizer shaft up & down.
4.4 Insert the wire
plug into the wall-mounted socket & press the ON button.
4.5 Open the air
supply valve & press the Up button for lifting the shaft of the
homogenizer.
4.6 Place the cleaned
container below the homogenizer shaft & press the Down Button.
4.7 Add Solvent &
other materials according to the BMR & start its operation by adjusting the
RPMs mentioned in BMR.
4.8 After completion
of the mixing process stop working by pressing the Off button, press the up
button to lift the shaft & remove the container.
4.9 Press the down
button to bring its shaft back, Press the Off Button & remove the wire.
4.10 Attach the 'To be
cleaned' label to the homogenizer, record the activity in the logbook of the
Homogenizer and sign it.
5.0 Abbreviations
5.1 SOP: Standard
Operating Procedure
5.2 BMR: Batch
Manufacturing Record
5.3 QA: Quality
Assurance
5.4 HOP:Head Of
Production
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