Evaluating Disposable Mixing Systems - Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development. - BioPharm International

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Evaluating Disposable Mixing Systems
Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development.


BioPharm International
Volume 22, Issue 2


Andrew Sinclair
At the moment, single-use mixing systems are fast evolving. This is reflected by the extent of ongoing innovation, which is presenting potential users with difficult choices to make. In this article, we present an overview of the current offerings in this area, discuss end-user feedback, and provide the suppliers' perspective on the latest technologies.


Table 1. Typical mixing applications and disposable technology options for cell culture
The situation for mixing systems is more complex compared with the use of bags for holding liquids because mixing systems are used for processing and the duty varies depending on the application. Table 1 summarizes the key applications and disposable technologies for cell-culture available in the market today. We are certain that this situation will gradually resolve itself over the next few years as leading technologies and companies gain acceptance and market share.


Miriam Monge
It is, however, important in this current environment that you use a formal risk-assessment methodology to select the right mixing system on the basis of technology maturity, economics, supplier dependencies, supply chain, and validation. In our previous column published in the December 2008 issue of BioPharm International, we described an approach that we have developed and successfully implemented for many projects that use disposable systems.

Besides the technology selection methodology outlined in our last article, the following are a few key points to consider when evaluating disposable mixing systems:
  • What are the benefits of moving to disposable technology as opposed to working with stainless steel mixing technologies for your given process? Can you quantify these benefits? Does moving to disposable mixing systems reduce the overall cost of goods of your process, improve operation flexibility, and product security?
  • Can a given disposable mixing technology be acquired from more than one vendor? If so, is it possible to do that for both hardware and consumables?
  • Does the mixing technology have solid intellectual property (IP)? It is to be noted that there are numerous patent claims in this area—the IP situation is quite complex.
  • Is the technology scalable?
  • Is the level of particulate generation of a given disposable mixing technology within defined limits?
  • How much floor and cleanroom height does the system require? How cleanable is the hardware?

The above list is not exhaustive but it illustrates the type of factors that need to be considered when selecting disposable mixing systems.

TECHNOLOGY ROUNDUP

In the current market, there are a large number of companies offering disposable mixing systems that evolve as companies introduce new developments and extend existing ranges. In this section, we provide an overview of the leading large-scale single-use products.


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