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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