PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Volume 15, Issue 2
Displaying 1-5 of 5 articles from this issue
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Regular Article
  • HIGH VOLUME PRODUCTION: INJECTABLE DEVICES ON THEIR PATH TO SUCCESS
    Reiner Zeidler
    2013 Volume 15 Issue 2 Pages 25-32
    Published: 2013
    Released on J-STAGE: December 10, 2013
    DOIhttps://doi.org/10.11347/pda.15.25
    JOURNAL FREE ACCESS
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      In this item, Reiner Zeidler, Sales Manager Medical Systems, teamtechnik Group, summarises the benefits of the company's modular TEAMED device production system, and its application and ready scaleability from prototype/Phase I clinical trials up through to Phase III to market.
      “This is made possible only with a very strong modular design of the teamed platforms, using individulally replaceable processes and a machine concept with pre-validated servo-actuated motors and cam-driven units”
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Technical Report
  • 3P'S ASEPTIC FILL2WEIGHTTM POWDER DISPENSER: AN ENABLING TECHNOLOGY FOR PARENTERAL RECONSTITUTION DEVICES
    Tom Bailey, Dave Seaward
    2013 Volume 15 Issue 2 Pages 33-46
    Published: 2013
    Released on J-STAGE: December 10, 2013
    DOIhttps://doi.org/10.11347/pda.15.33
    JOURNAL FREE ACCESS
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      The trend within the pharmaceutical industry towards large-molecule biologic drug substances is well documented. Due to the fragile nature of these compounds, they often need either cold-chain logistics or reconstitution prior to administration. Innovation in reconstitution devices and in formulations has been stifled by the inability of conventional powder handling systems to dispense small and precise amounts of reconstitution powders aseptically.
      This paper, from Tom Bailey, Managing Director, and Dave Seaward, Projects Director, both of 3P Innovation, describes how the company's innovative gravimetric Fill2WeightTM system overcomes these technical challenges to enable advances in both formulations and parenteral device design.
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  • A NEW ELECTRONIC MULTIUSE AUTO-INJECTOR: THE FLEXI-Q EMU
    Menachem Zucker
    2013 Volume 15 Issue 2 Pages 47-52
    Published: 2013
    Released on J-STAGE: December 10, 2013
    DOIhttps://doi.org/10.11347/pda.15.47
    JOURNAL FREE ACCESS
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      In this article, Menachem Zucker, PhD, Vice-President and Head of the Injectable Drug Delivery Devices (I3D) Division at Elcam Medical, provides insights into the world of biological drugs and Elcam Medical's innovative drug delivery solutions.
      “Elcam believes that pharmaceutical companies will have a significant and growing need for different auto-injectors.
      Each pharmaceutical company will require a unique design and shape of the delivery device to fit their specific drug and users.”
      “Elcam medical delivers not just a product, but a promise: to combine excellence with commitment; to weave together reliability with integrity; and to offer competitive pricing for superior results”
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Topics Review
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