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  • VICTREX (R) PEEK Meets NORSOK M710 Compliance and Continues to Aggressively Test its Polymers in Support of Industry-Leading Test Standards
    (DRAFT), offer. a wider scope of test environments and classifications. for the temperature 'index' of the approval rating. Both of these recent documents still rely on an. Arrhenius approach and specifically have limits of. testing temperature which end at 225°C (437°F). Although
  • Interphex Stands Test of Time (and Economy)
    By Paul Thomas, Senior Editor Budzar offers custom-built heat transfer systems specific to pharma, whether temperature control modules, low temperature chillers, biowaste systems, process skid packages, or a portable vessel heating/cooling system. Each custom unit or system design includes approval
  • ISA100.11a Multi-Vendor Industrial Wireless Products in Sction (.pdf)
    Within days of approval of the ISA100.11a standard by the ISA Standards and Practices Board, the ISA100 Wireless Compliance Institute installed a multi-vendor User Test of the technology at an Arkema plant in Crosby, Texas. This User Test demonstrates interoperability among multiple vendor devices
  • The Future of Barrier Packaging
    are already examining how to use barrier packaging to reduce stability testing overhead in two separate arenas: pre- and post-approval. In the pre-approval world, if barrier packaging can reduce the time to approval, it will benefit the company, either by accelerating stability testing or enhancing
  • Design of Lugs
    cases, a very costly test programme is then quickly performed to provide data that then have to be validated for approval by the certification or regulatory authorities. A trend has been noted where the availability of validated (specialised) material properties increasingly dominates material selection.
  • How Part 11 Compliance Impacts QbD
    two years, pilot programs have shown an increased approval speed for new products drawing on elements of Quality by Design. Despite this progress, the largest question remains: given that so many FDAregulated firms view their preclinical product development process as ?outside the box? of FDA
  • Bayer Warms Up to Cold Chain Supply
    , to design, test and qualify trailers for frozen and refrigerated conditions. Skelton had already introduced some innovations. It was one of the first carriers to link temperature monitors and controls inside the trailer with an in-cab alarm system that notifies drivers of sudden changes in temperature
  • FDA's Chris Watts on New Directions for PAT at FDA
    advocated eating the elephant. Having come from industry, I knew that if you can prove the concept to management with moisture or blending or raw materials, then you get approval and funding for the next step. Prove it then move on from there. Low hanging fruit is one good way to characterize it. Looking
  • Peter Pande on Six Sigma Success: Don't Get Mired in the Details
    a promising product through the pipeline, from clinical to approval. In some sub-processes, classic Six Sigma wouldn 't apply, but it would apply to others. It must be tailored to the circumstance. What 's often misunderstood about Six Sigma is the fact that there are some principles bandied about
  • Advancing Your Career in a Changing Industry
    approval process has become significantly more complex and costly. The regulatory agencies are more sophisticated and capable in evaluating drugs than in the past. Consequently, their standards for approvals are significantly higher. This, in turn, is forcing pharmaceutical companies to test
  • How Early Communication with FDA Sped Up One RMM Implementation
    , and where did you want to apply it? Naturally, one of the major draws was faster product release, but RMM s sensitivity and ability to zero in on specific organisms were also key factors in the decision. We wanted to use RMM instead of traditional microbial limits test for end release products
  • How Part 11 Compliance Impacts QbD
    two years, pilot programs have shown an increased approval speed for new products drawing on elements of Quality by Design. Despite this progress, the largest question remains: given that so many FDAregulated firms view their preclinical product development process as ?outside the box? of FDA
  • Drug Security Gets (Nano-) Granular
    technology, and I think the appreciation of that technology. And first of all, I think it 's important that really, until this year, our technology was very much a ... nice concept. In February, we passed a factory acceptance test for our nanoencrypter for our number one client, who is a top ten

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