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| Oscillating Granulator |
SOP For Oscillating Granulator
Standard Operating Procedure for a Oscillating Granulator
1.0
Purpose
The
purpose of this SOP is to establish a standard procedure for operating the
Oscillating Granulator.
2.0 Scope
This SOP is applicable
for the Oscillating Granulator in the granulation area of the production
section.
3.0 Responsibility
3.1 Machine Operator
is responsible for operating the Oscillating Granulator.
3.2 Production Officer
is responsible for implementation of this SOP.
3.3 The Head Of
Production is responsible for ensuring the implementation of this SOP.
3.4 Q.A Officer
monitors the compliance of this SOP.
4.0 Procedure
4.1 Production
Pharmacist will ensure that the Oscillating Granulator and the area is properly
cleaned.
4.2 Production
Pharmacist will ensure that the Oscillating Granulator and Area is labelled
with Cleaned label status.
4.3 Before starting
the operation of a Oscillating Granulator, take line clearance from the QA
officer and affix product related labels to the Oscillating Granulator
and Area.
4.4 During line
clearance,take a cleaned sieve or mesh as mentioned in BMR and verify it by the
Pharmacist & Q.A officer and install it to the granulator.
4.5 Attach a polythene
bag to the lower side of the oscillating granulator to collect the sieved
material.
4.6 Add dried
granules/powders to be sieved in the hopper of an oscillating granulator
and press the ON button to start sieving operation.
4.7 During sieving
operation cover the hopper of the granulator with a lid to prevent generation
of dust and to control line loss.
4.8 After completing
the sieving process, press the off button and remove the polythene bag to check
the weight of granules to calculate the product yield.
4.9 Affix it, to be
cleaned, label and record the activity in the logbook of the oscillating
granulator 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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