Pharmaceutical Technology Europe - October 2010 - (Page 8)

Material compatibility and single-use systems Life science industry users of single-use devices have legitimate questions about the potential for leachables to impact the quality of their pharmaceutical products. Extractables data using model solvents can be a useful indicator of leachables risk, but until now users have struggled to make like-for-like comparisons between the various single-use technologies they are considering. The Bio-Process Systems Alliance (BPSA) guides do a great job of clearing the fog and demystifying the myths surrounding the extractables and leachables debate, establishing which testing is most valuable and which testing is less so. This has obvious benefits, not only for users, but also for suppliers. before. In fact, when our customers are planning to implement a new single-use technology, the biggest hurdle they face is probably materials validation — raw materials need to be more traceable, the supply chain needs to be entirely free of animal-derived components and change control needs to be more rigorous. What was considered acceptable just a few years ago would not pass muster today. …when our customers are planning to implement a new single-use technology, the biggest hurdle they face is probably materials validation… If we can offer new technology made from a material that the client has already validated for contact with their product, the validation hurdle can be eased dramatically. If the client already has a mixing bag film validated for contact with their drug We are not quite there yet, but the BPSA guides are a critical step in the right direction. I look forward to a not-too-distant future when contact material harmonisation will allow users to pick the technology that works best for them without worrying about materials compatibility at all. PTE Richard Bhe lla Validation Pharmaceutical contact materials for single-use processes are under the microscope now more than ever product, for example, then validating the same film for storage applications should take much less effort than if the client was to use a new film. Today, every end-user must still use their own knowledge and intuition to decide on what tests are required for materials used for single-use systems. I would love to see end-users and single-use suppliers reach a strong and clear consensus on materials compatibility testing. Based on a contribution by Richard Bhella, Global Product Manager, Single-Use Storage and Delivery Technologies at ATMI Lifesciences. To read the full version of this article, go to www.pharmtech.com/bhella www.atmi-lifesciences.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/bhella http://www.atmi-lifesciences.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