Saturday, July 24, 2021

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

Also Read:

SOP for Rapid Mixing Granulator.

SOP for Spiral Mixer/Sigma Mixer

SOP for Double Cone Blender.

Monday, July 19, 2021

Problems During Granulation|Granulation Defects

Granulation is a process of converting fine powders into large agglomerates by using binder solution, solvent or application of pressure.

Granulation is the most widely used method in pharmaceutical industries for manufacturing tablets.

The process of granulation in which we use binder solution or solvent to convert fine powders to granules is known as wet granulation and the process in which we convert fine powder into granules by applying pressure is known as dry granulation.  

In this article, we will discuss the common problems which may occur during granulation and affect product quality.

Thursday, July 8, 2021

Kyron|Polacrilin Potassium

Polacrilin Potassium also known as PP is an excipient used in pharmaceutical formulations.This excipient is not used in the majority of pharmaceutical industries because it is not a common excipient but it has many good properties and is used in pharmaceutical dosage forms.

Other Names

  • Kyron

  • Potassium Salt