Matcon Blog / Articles

Quality Issues of Segregation and The Pharmaceutical Equipment to Use?

Published on 20 March 2018

Good better and best pharmaceutical equipment

Having got the building design right for your pharmaceutical manufacturing needs, whether that is a single story manufacturing floor or multiple floors, it is important to choose the right container-based materials transfer system that will ensure that your pharmaceutical equipment is functioning well and factory production flow is optimised.   As you start to investigate which IBC is the best, don't be driven by price alone.  What initially looks like a cheaper option may not give you the performance you ultimately need.  It is worth doing your research and understanding the benefits and limitations of the different types of IBC on the market today.  We have created a handy checklist of the types of questions to ask when making that selection.

The type of IBC you choose depends on many different factors which we will explore in a series of blogs over the coming weeks. This blog looks at what to consider if you have a product that is prone to segregation as it transfers between the pharmaceutical equipment.

How Segregation Can Occur:

  • Segregation occurs when particles separate due to differences in their size, shape, or density.  It can be caused by the way in which a powder blend is handled throughout the production process. 

  • If dry granulation using roll compaction is a process step in your pharmaceutical manufacture, again it is important to prevent material from segregating as the quality of the granules produced are dependent upon the quality of the in-feed from the IBC. 

  • It is well known in the industry that butterfly valve and slide valve IBCs can cause material segregation as they create core or funnel-flow during the discharge process.  Flow of material only occurs in a narrow vertical channel from the open area of the outlet to the top surface of the material in the container, creating a hole within the vessel, also known as ‘rat-holing’.  As the material on the top always prefers to flow towards the central core it results in material being held along the sides of the vessel, as the powder moves to the central core it enables particles to roll and separate creating segregation.

The Implications of Segregation Are Critical.

If the material de-mixes or segregates as it is being fed into the tablet press it will result in the incorrect proportions of active ingredient in each tablet – and result in batches having to be scrapped.  If you can’t guarantee production quality it will lead to issues with the regulatory authorities.

Solutions to Powder Blend Segregation

To prevent the problem of powder blend segregation you need to look for IBCs that promote mass-flow discharge. Upon discharge, all the material in the container moves at the same rate across the whole container, creating uniform flow – no stagnant material, no rat-holing and a first in-first out sequence of material movement.

cone valve discharge within the pharmaceutical equipmentMass-flow discharge can be achieved either by selecting a container with the correct angle of the hopper section or using Cone Valve IBCs.

At the heart of the Matcon IBC system is our unique Cone Valve that has been used by the Pharmaceutical industry for over 35 years.  As the cone lifts, it creates an annular gap at the outlet of the IBC which results in all product in the IBC cross-section moving at the same time.  Material prefers to flow down the vessel walls rather than the core, consequently there is no movement of individual particles across each other, or rolling or dead zones – hence no segregation. All material has a uniform residence time within the IBC.  It ensures a regular feed of product to the downstream pharmaceutical equipment, which is of a high quality and will meet the regulatory standards.

See Matcon’s Cone Valve IBC in Action

By using Matcon Cone Valve IBCs you maintain a perfectly homogenous mix right to the end of the batch, imperative to ensuring a top quality product every time and no scrapped batches of product. To see the Cone Valve in action, click this link to view the video.

How Matcon Helps Pharmaceutical Manufacturers

A further vital aspect to achieving a successful installation of an IBC system lies with the experience of how to apply the technology into the various processing steps and connect it to your existing pharmaceutical equipment. This is where the Matcon team offers great value – we strive to supply you with a system that brings you the maximum profitability and product quality. We aren’t just selling IBCs as a commodity, we take a full look at what your manufacturing needs are and designing a system that handles your batches in the right quantities, optimises the use of processing equipment and reduces the amount of manual handling needed to produce your product. We help you to make the right investment.

In order to help you select the right IBC for your needs, we have compiled a helpful checklist of questions to ask potential suppliers to ensure you make the right pharmaceutical equipment choices.

Selecting a Supplier of the Ideal IBC Sytem. Make sure you ask the right questions. Download the free checklist
Posted by Richard Lockwood

Topics: Pharmaceutical, Tablet Handling, Segregation