Novel Manufacturing Strategy: Continuous Manufacturing - Development Case Study

The pharmaceutical industry is still dominated by 'frozen' batch processes with little, if any, automatic feedback control. This paradigm is predicated on the mindset that uniform products can only be produced by batch processes having a 'frozen' manufacturing process. This perspective also presumes a dated interpretation of regulatory quality requirements, where the process is "validated" and never changed afterwards, missing the reality of continuously changing raw materials and other process inputs.

In reality, batch processes are not particularly good for product quality assurance, and possess a number of drawbacks such as poor controllability, low yield, problematic scalability, and energy inefficiency. In addition, batch processes are labor intensive and typically exhibit low plant productivity. One of the advantages of the batch processes is flexibility. Thus, ongoing efforts have focused on designing significant flexibility into continuous processes, to remove this "advantage" of batch systems.

Given the unique confluence of the patent cliff and the growing quality expectations of the regulatory system, the time is now for the pharmaceutical industry to evolve from the 'frozen' batch manufacturing process characteristic of the 19th century, to automatic controlled continuous manufacturing which will dominate the 21st century.>

The previous is an excerpt from a short paper of  Prof. Dr. Fernando Muzzio from Rutgers University, USA, and his team. To read the complete paper please see "Flexible Multipurpose Continuous Processing of Pharmaceutical Tablet Manufacturing Process".

Prof. Dr Fernando Muzzio from Rutgers University, USA, is one of the leading experts in the field of Continuous Manufacturing. He will address "Material Properties in the Design of a Direct Compression Continuous Manufacturing System" at the Universtiy of Heidelberg QbD/PAT Conference 2012 from 26 - 27 September 2012 in Heidelberg. A number of material properties of pure ingredients and blends are critical to the performance of continuous manufacturing processes for solid dosage forms. Prof. Muzzio will review those methods for measuring these material properties and assess their impact on the process and on the product.  

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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