Pharmaceutical Technology Europe - October 2010 - (Page 3)

Harnessing the advantages of single-use systems There are several key advantages that single-use systems offer over conventional stainless steel equipment. Some of the most important include no cleaning and associated cleaning validation, mitigation of cross-contamination and faster changeover campaigns. The extent to which the above advantages can be harnessed, however, is predicated on the infrastructure and stage of a given pharmaceutical manufacturer. In reality most manufacturers tend to incorporate both single-use and conventional technologies. and feasibility or predicated on size; for example, the maximum capacity for a single-use bioreactor is 2000 L. Biopharma, as a subset of the pharmaceutical industry, has been an early adopter of single-use systems. This is, in part, due to the compatibility of the biological manufacturing processes, which are largely aqueous based, with current single-use materials technology. In contrast, the pharmaceutical industry, which predominantly uses chemical synthesis, has not been able to implement single-use systems as readily because of inherent solvent compatibility challenges with first-generation product contact materials such as polyethylene, which is predominantly used in biocontainers. The challenges with respect to reaction conditions remain largely unaddressed, processing operations, which will also provide the opportunity for process streamlining and the promise of further economic benefits. Ultimately, the implementation of single-use systems, however, will be derived from the industry market drivers themselves, such as the need to use manufacturing innovation as a means for cost control. PTE Christian Ju lien Overcoming challenges Single-use systems also impose challenges. One of the most prominent issues is supplier dependency, with other challenges being mainly based on technical merit although the issue of inherent material incompatibility is now being mitigated somewhat with the development of more chemically resistant product contact materials. During the next few years, one of the most important trends in the evolution of single-use systems implementation is likely to be the integration of fluid management systems and single-use unit Based on a contribution by Christian Julien, One-Touch Single-Use Systems, Business Development Manager, at Meissner Filtration Products. To read the full version of this article, go to www.pharmtech.com/julien www.meissner.com 1 CONTENTS 8 MATERIAL COMPATIBILITY 3 HARNESSING THE ADVANTAGES 10 SINGLE-USE BIOREACTORS 6 CMO ADOPTION 11 QUALITY AGREEMENT TEMPLATE 7 VALIDATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/julien http://www.meissner.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2010

Table of Contents
Pharmaceutical Technology Europe - October 2010
Our Survey Says...
Harnessing the Advantages of Single-Use Systems
Should You Implement Single-Use Systems?
CMO Industry Adoption of Single-Use Technology
Validating Single-Use Systems
Material Compatibility and Single Use Systems
Achieving More Effective Cell Culture with Single-Use Systems
The Pros and Cons of Single-Use Bioreactors
Developing a Quality Agreement Template for Single-Use Systems
Ten Top Single-Use Technologies Showcased

Pharmaceutical Technology Europe - October 2010