Are you looking for production equipment to manufacture pellets or spheroids in the pharmaceutical or other industries?

People call us and ask....

Quite often we are contacted by companies looking to source and establish a pellet production manufacturing line based on the techniques of extrusion and spheronization. They usually begin by asking about production equipment availability, cost and through-put (or production rates) so that they can establish a base for budgeting and costing the production process. At first sight this may appear to be a sensible and normal way to begin to look at their production planning system. But are these the best questions to ask?

How we respond....

At Caleva, we normally respond by asking questions about the formulations they are planning to work with and the parameters that they may have established for the extrusion and spheronization of their products. Many companies already have and share this information. Generally we are able and willing and help in these cases. The more information that the company has, and the more they are willing to share with us (generally within the framework of a non-disclosure agreement) the more we are able to help. In this way the company can more accurately plan and assess the feasibility of commercial pellet production.

The issue that we have to resolve....

On the other hand a surprising number of companies try to estimate production equipment requirement and costs without first establishing, on a lab scale, the basic production parameters that the desired potential sales volumes will require. This makes the estimation of the costs associated with production difficult to meaningfully establish.

What other factors do you need to consider?

A Caleva Spheronizer 700 can effectively operate with a load between 1 kg to 15 kilos. Different load sizes can have an effect on the results. In a recent manufacturing installation, very small pellets were required but it was discovered that in loads greater than 4 kilos the size of the pellets increased slightly. Before making predictions regarding the optimum load in the spheronizer, it is advisable that full trials are undertaken on both laboratory scale and production scale equipment. Caleva can help you with this!

Spheronization time is generally around 3 to 8 minutes but we have experience of commercial applications where certain products spheronize outside this range. The shortest spheronization time (in actual commerical use) known to us is 27 seconds and the longest is 14 minutes.

The implications of this relatively simple factor is that if a company wishes to make budget estimates for a particular manufacturing requirement, then if the details of the process have not been determined at a laboratory level, or if there is no information available from other outside sources, to make these estimates from “guess work” and general observations could lead to very inaccurate figures. We recommend that laboratory trials to establish or modify general formulation properties are essential before any decisions are made about the investment required for manufacturing.

How do we resolve the issue of uncertainty?

In general (but not always) the slowest part of the extrusion and spheronization process is the spheronization step. In basic systems the overall productivity of the whole process is determined by how much you can get through the spheronizer in a fixed time period.

This is determined by the “residence time” (the length of time the product remains in the spheronizer).
For most “normal” products the residence time in a spheronizer is approximately 3 to 8 minutes.
If this time is added to the time required to load in the spheronizer for each run (say, 1.5 minutes) and to unload the spheronizer (say, another 1.5 minutes) then the total run time per batch can be calculated.
Therefore, an estimated productivity per hour can be established and estimations can be made of the equipment requirement and the potential investment.

caleva-production-extruder-spheronizer-to-manufacture-pellets-spheroids-or-extrudate_lrg

Is this relevant to you?

The notes above refer particularly to the extrusion and spheronization process, but as a general concept, any company planning scale up to production are well advised to ensure that proper development work is undertaken at an early stage.

If you are thinking about production equipment and need to complete some laboratory development trials then contact Caleva to see if our development laboratory is available for you to use.

Initial trials can be made in the Caleva laboratory using the Caleva Multi Lab (CML) that offers several advantages:-

The smallest samples requirement possible for meaning full results with minimum use of expensive or scarce product.
The smallest bench top space requirement compared to any other system available.
The fastest throughput of trial iterations.
The ability for you to test the effect on your product of different extrusion pressures.