Clearinghouse

    Are Single-Use Technologies Changing the Game? - By Kevin Ott
    Published in BioProcess International, May 2011, Supplement

    Indicators suggest that Single-Use Technologies (SUTs) will continue to emerge as reliable and affordable enabling technologies within a complex future drug market that is just now coming into focus. The ultimate wide-scale adoption of SUTs will still be based on performance, price, safety, risk, and user-comfort factors. The extent to which SUTs become a real game changer – and how fast it happens – will depend on many factors, not the least of which is the ultimate performance of these systems compared with traditional facilities. As we have seen, the benefits are comparable at a greatly reduced economic scale.

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    Standardizing Single-Use
    From Life Science Leader November Edition

    Interview with BPSA member company representatives Bill Hartzel of Arkema, Inc, John Boehm of Colder Products, Inc. and Paul Priebe of Sartorius-Stedim Biotech on development of best practices for validation of single use systems as published in the November 2010 edition of Life Science Leader.

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    Validating Single-Use Systems
    By Tony Hitchcock and George Saunders (RecipharmCobra Bio),

    Authors discuss validation of single use systems incorporating the established approach of user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Changes of emphasis within these steps specific to single-use systems are discussed.

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    This article is part of a special feature on single-use systems that was published in the October issue of Pharmaceutical Technology Europe Digital, available at http://www.pharmtech.com/ptedigital1010

        

        

    CMO Industry Adoption Of Single-Use Technology
    By: Mark Kruszynski (Senior Principal Engineer, Baxter)
    Published October 1 in PharmTech

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    BPSA Marketing Committee Chairman Todd Kapp of BPSA Member American Renolit Corp. speaks on Single Sourcing with Single-Use Technologies during Interphex, March 2010

    Single Sourcing with Single-use Technologies - Todd Kapp, Business Development Manager, American Renolit Corporation and Marketing Committee Chairman, Bio-Process Systems Alliance (BPSA) speaks on Single Sourcing with Single-Use Technologies during Interphex, March 2010

        

        

        

        

    Extractables & Leachables Testing for Single-Use Bioprocessing Equipment: Assessing Risk, Leveraging Knowledge, and Protecting Patients

    Extractables & Leachables Testing for Single-Use Bioprocessing Equipment: Assessing Risk, Leveraging Knowledge, and Protecting Patients - On-demand webcast featuring Michael Ruberto, PhD, President, Material Needs Consulting, on sources of extractables and leachables from plastics and elastomers, Jerold Martin, Sr. VP, Global Scientific Affairs, Pall Life Sciences and Chairman of the Board and Technology Committee, BPSA, on BPSA's recommendations for extractables analysis and the updated BPSA Extractables Guide (2010), and Dennis Jenke, Principal Scientist Physical and Chemical Sciences, Baxter Technology Resources, on risk-based approaches to assessing the impact of extractables and leachables on product quality and structuring an E&L program to address those risks. Recorded March 23, 2010; 60 minutes.

        

        

    Challenges in Sterilizing Grade Filtration

    Challenges in Sterilizing Grade Filtration - Jerold Martin, Pall Life Sciences and Chairman of the Board and Technology Committee, BPSA, along with BPSA members; Maik Jornitz of Sartorius-Stedim Biotech and Maurice Phelan of Millipore Corporation discuss best practices for sterilizing filtration during Interphex, March 2010; "12" minutes.