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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