Wet Granulator/ Wet Mill
SOP For Wet Granulator, Wet Mill
Standard Operating Procedure for a Wet Granulator or Wet Mill.
1.0
Purpose
The
purpose of this SOP is to establish a standard procedure for operating the Wet
Granulator or Wet Mill.
2.0 Scope
This SOP is applicable
for the wet Granulator or Wet Mill in the granulation area of the production
section.
3.0 Responsibility
3.1 Machine Operator
is responsible for operating the wet granulator or Wet Mill.
3.2 Production Officer
is responsible for implementation of this SOP.
3.3 The HOP is
responsible for ensuring the implementation of this SOP.
3.4 The Quality
Assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Production
Pharmacist will ensure that the wet granulator or wet mill and the area is
properly cleaned.
4.2 Production
Pharmacist will ensure that the wet granulator or wet mill and area is labelled
with Cleaned label status.
4.3 Before starting
the operation of a wet granulator or wet mill, take line clearance from the QA
officer and affix product related labels to the wet granulator or wet mill 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 wet granulator or wet mill.
4.5 Place a SS container
below the discharging chute of the wet granulator or wet mill to collect the
sieved wet material.
4.6 Add wet mass to be
sieved in the hopper of wet granulator or wet mill and press the ON
button to start sieving operation.
4.7 After completing
the sieving process, press the off button and remove the SS container.
4.8 Affix it, to be
cleaned, label and record the activity in the logbook of the wet granulator or
wet mill and sign it.
5.0
Abbreviations
5.1
SOP: Standard Operating Procedure
5.2 BMR:
Batch Manufacturing Record
5.3
HOP:Head Of Production
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