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| Propeller Mixer |
SOP For Propeller Mixer
Standard Operating Procedure for Propeller Mixer.
1.0 Purpose
The purpose of this
SOP is to develop a standard procedure for operating the Propeller Mixer.
2.0 Scope
This SOP is applicable
for the propeller Mixer used in the granulation,coating & liquid
manufacturing area of the production section.
3.0 Responsibility
3.1 Machine Operator
is responsible for operating the Propeller Mixer.
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 Pharmacist shall
ensure that the Propeller Mixer & the area is properly cleaned.
4.2 Production
Pharmacist shall ensure that the Propeller Mixer & Area is labeled
with Cleaned label status.
4.3 Before starting
the operation of Propeller Mixer, affix product-related labels to the
Propeller Mixer & Area and take line clearance from the QA officer.
4.4 After line
Clearance, rotate the lifting handle of the propeller mixer to lift the
propeller blades.
4.5 Place a mixing
container below the propeller blades & bring down the blades.
4.6 Add required
quantity of Solvent in container as mentioned in BMR.
4.7 Insert Wire plug
of Propeller mixer into the socket & press On button.
4.8 Adjust the RPMs of
the Propeller Mixer and add materials to be mixed according to the BMR.
4.9 When required mixing
operation is completed press Of button,remove wire plug,lift propeller blades
up & remove mixing container.
4.10 Attach Propeller
Mixer 'to be cleaned' label and record the activity in the logbook of the
Propeller Mixer 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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