Extruder Spheroniser , Extruder and Spheronizer

Extruder & Spheroniser, Extruder & Spheronizer

In the production of pharmaceutical pellets, the process of Extrusion & Spheronization  is commonly used . This four step process consists of wet mixing, extrusion, spheronization, and drying/coating. The pellets are then encapsulated, tabeleted, or dosed into sachets. Pharmaceutical pellets range in size from 0.6 to 1.2 mm. Spheronization, is the third step in the Extrusion and Spheronization process. During this step, cylindrical extrudates (from the previous step) are converted into spheres.

Explanation as per wikipedia 

Step 1: Wet Mixing

The ingredients are generally mixed (or granulated - the process is called granulation) in either a high-shear granulator or a more simple planetary mixer.

Step 2: Extrusion

The wet mass (or granulation) is extruded to form cylindrical extrudates of a constant diameter (normally 0.6 - 1.2 mm). The wet mass is passed through the screen forming soft, pliable extrudates (similar to pasta) which break by their own weight into shorter units. The size of the final pellets (spheres) is principally determined by the hole diameter of the screen (or die) used in the extrusion step. For example in order to obtain spheres with a diameter of 1 mm, a 1 mm screen is used on the extruder, although spheres with a distribution of 0.8-1.2 mm may often be obtained.

Types of Extrusion and Extruders for making pellets

All extrusion processes are based on the generation of pressure within the material and when materials are put under pressure heat is generated. This cannot be avoided but different extrusion types generate different amounts of heat. There are basically three different types of extruder and the one chosen may have far reaching implications on production operations. It is vitally important that the right type of extruder is chosen as this is a critical decision that will have long term implications.

Screw driven extruders (with radial or axial output) Screw driven extruders move the product to the extrusion die head along an axis by the use of a screw thread. The product is worked hard for quite a long time and it is a fact that this process generates a huge amount of heat. This cannot be avoided and all screw extruders do this. The generation of heat is useful in many industries such as plastics or food but for pharmaceutical products or any other products that can be damaged by heat this can be a disaster. This is especially true when high volumes and continuous extrusion are required. It is possible to add cooling systems to screw driven extruders but these are often not very efficient at keep the product cool during the process even though they may keep the equipment cool! It is recommended if you have restrictions on the amount of heat allowed, that any screw driven extruder is avoided. This is particularly true if you want to extrude product through very small holes (which you will if you need very small pellets). The diameter of the final pellets is largely determined by the diameter of the extrudate you will be extruding through small holes in the extrusion die. A screw extruder film

Basket or screen extruders: There are two main types of mechanisms. One type scrapes the product through the screen and the other type uses rollers that push the product through the screen. The type with the roller action is marginally gentler on the product but both types do generate some heat. The heat generated in screen extruders is significantly less that the amount of heat generated with screw driven extruders. Screen extruders are generally suitable for a great number of pharmaceutical formulations and they are widely used in the pharmaceutical industry. They are also the lowest cost extruder to make for any particular required capacity. This is why they are widely used. A production screen extruder in operation

Gear Extruders: Gear extruders are less well known but have significant and real advantages when extrudate is required of products that are sensitive to heat. The principle of operation is quite different from other extruders. The product is allowed to fall between two rotating gears. The base of the gear form has holes so that the product is pushed through the base of each gear tooth into the hollow centre of the gear and falls out of the front of the gear. A small film of how gear extruders operateThis process is the type of extrusion that generates the least possible amount of heat. This low generation of heat is principally for three reasons;

1. Very little work is done to the product before it enters the extrusion teeth and the actual moment when the product is pushed through the holes in the die.

2. The product moves through the extrusion holes very quickly and emerges into the centre of the gear. Because the extrusion is very quick and the time the product is under pressure is short very little heat is generated.

3. Finally because the gears themselves are significantly large and solid lumps of steel any small amount of heat generated is easily transferred away. The point of extrusion in both screw fed and screen extruders is much less solid and therefor the transfer of heat away from the product is significantly slower.

Step 3: Spheronization

Spheronization is a batch process. Extrudates are charged to the spheronizer and falls on the spinning plate. During the first contact of the cylindrical granules with the friction plate, the extrudates are cut into segments with a length ranging from 1 to 1.2 times their diameter. These segments then collide with the bowl wall and they are thrown back to the inside of the friction plate. Centrifugal force sends the material to the outside of the disc. The action of the material being moved causes the extrudate to be broken down into pieces of approximately equal length related to the diameter of the extrudate. These cylindrical segments are gradually rounded by the collisions with the bowl wall and the plate and each other. The ongoing action of particles colliding with the wall and being thrown back to the inside of the plate creates a “twisting rope movement” of product along the bowl wall. The continuous collision of the particles with the wall and with the friction plate gradually converts the cylindrical segments into spheres, provided that the extrudates are plastic (pliable) enough to allow the deformation without being destroyed or sticking together. It is essential that this rope movement is present for an optimal spheronization. When the particles have reached the desired level of sphericity, they are then discharged from the spheronizer.

Step 4: Drying/Coating

Wet pellets are collected and dried in a vertical fluid bed drier (FBD) or in some instances a tray hot with a flow of hot air covering the pellets. The FBD can also be used to coat the pellets (using a Wurster insert) if so desired.

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