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  1. Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644
    10/28/2014

    This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.

  2. A Five-Step Approach To Optimizing Cost And Performance In The Temperature-Controlled Transport Of High-Value Pharmaceutical Shipments
    10/24/2014

    Important things come in packages of all sizes, especially in the world of temperature-controlled, pharmaceutical transport, where it is not uncommon for even the smallest shipment to have a far-reaching impact on researchers, manufacturers, healthcare providers and patients.

  3. EMC® Documentum® Submission Store And View
    10/17/2014

    Are you having a hard time finding and keeping track of your organization’s growing volume of electronic submissions and regulatory correspondence? You’re not alone. Efficient access to archived submissions, along with their associated correspondence, has become a challenge that almost every life sciences firm grapples with.

  4. EMC® Documentum® Submission Store And View Brochure
    10/17/2014

    Are you having a hard time finding and keeping track of your organization’s growing volume of electronic submissions and regulatory correspondence? You’re not alone. Efficient access to archived submissions, along with their associated correspondence, has become a challenge that almost every life sciences firm grapples with.

  5. A 15 Minute Guide For Life Sciences Quality And Manufacturing Organizations
    10/17/2014

    Life Sciences quality and manufacturing organizations face three critical industry forces:  increasingly stringent regulation; globalization; and virtualization of supply networks.

  6. 3 Ways Mobile Supply Chain Solutions Make A Difference
    10/17/2014

    Try to remember the days before ubiquitous smart mobile devices. They seem like prehistoric times now, but it was less than 10 years ago.

  7. EMC® Documentum® Quality And Manufacturing
    10/17/2014

    Getting to market quickly is critical to the success of your business. In short, that requires running lean, efficient and uninterrupted manufacturing production at the lowest possible cost. But how efficiently you manage document creation, review, approval and change management can impact time to market, especially when you're dependent upon a global, virtual extended enterprise.

  8. EMC® Documentum® Research and Development
    10/16/2014

    Accelerate the creation, review and approval of regulatory submission documentation.

  9. EMC® Documentum® Research and Development Brochure
    10/16/2014

    Accelerate the creation, review and approval of regulatory submission documentation.

  10. Advances In Protein Production Bring New Options For Flexibility In Bioprocessing
    10/15/2014

    Advances in protein production, including biomaterials and cell culture, have resulted in new methods for bioprocessing that can increase both yield and quality as well as decrease cost and time. Trisha Gladd, editor of Pharmaceutical Online and Bioprocess Online, spoke with Dr. Mike Ultee, Chief Scientific Officer at Gallus Biopharmaceuticals, about not just these new options but also the future of bioprocessing.

     

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