Foreign Particulate Matter Investigations

Building a Successful Foreign Particulate Matter (FPM) Program

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  • 9:00AM Dec 15, 2014
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Stories of foreign particulate matter (FPM) found in medication and food products often occur in the news. FPM doesn’t just influence the effectiveness of a product; it can lead to product recall and regulatory action from government entities. Investigating the cause can be expensive, but a carefully designed Quality by Design (QbD) particulate program can […]

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Addressing Polystyrene Manufacturing Issues at the Micro/Nano Scale

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  • 1:26PM Dec 01, 2014
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Challenge: A manufacturer was experiencing production issues associated with polystyrene vessels in a life science application. Our challenge was to investigate the problem, which was impacting multiple product lines, to determine the root cause of failure and provide a means of resolution. Material: Polystyrene is critical to biomedical research and science. Its optical clarity and […]

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glass delamination pharmaceutical vial root cause

Making the Case: Using the SEM in Glass Delamination Investigations

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  • 10:07AM Mar 10, 2014
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The life sciences industry faces persistent challenges in assuring glass compatibility with products. One of the most serious challenges is that of glass delamination. Glass delamination, which occurs in vials, is a complex result of various factors including product composition, glass composition, glass forming temperature, and surface treatment. When delamination results in lamellae (flakes) or […]

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Working Together to Prevent Pharmaceutical Counterfeiting

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  • 3:40PM Dec 13, 2013
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Counterfeit drugs are a significant threat — to patient safety, to public health, to supply chain integrity — raising concerns over potential liability for consumers, manufacturers, distributors, pharmacies, governments, and other entities. As supply chains become more complex and global, efforts to combat the use of counterfeit drugs pose new challenges. In 2010 alone, counterfeit […]

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Can Raman Spectroscopy Shed Light on your Biotechnology Challenges?

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  • 5:04PM Oct 29, 2013
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Challenges in the field of biotechnology are always evolving. So, too, must our tools and techniques for solving novel problems. Although Raman analysis has been around since 1928, the scientific community is only now beginning to embrace this technology’s improved capabilities, portability, and low cost. Raman analyses provide insight across the entire product lifecycle, from […]

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Discover Electron Microscopy’s Role in Glass Defect Investigations at the PDA Visual Inspection Forum

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  • 12:59PM Sep 25, 2013
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Wow, I can’t believe that fall has arrived – but with the changing of the seasons comes the 2013 Parenteral Drug Association (PDA) Visual Inspection Forum.  After perusing the agenda, I can’t wait to attend the session presentations and learn from industry case studies. I expect there will be many regulatory updates as well – […]

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Download Our Webinar: “From Detection to Investigation: Know Your Product’s Connection with FPM”

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  • 11:38AM Sep 21, 2013
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In case you missed it, I recently teamed up with Carol Whitinger of SoloHill Engineering to present a free webinar on Foreign Particulate Matter (FPM) entitled, “From Detection to Investigation: Know Your Product’s Connection with FPM.”  I want to invite you to download a copy of the webinar, in case you were unable to attend […]

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Wash. State Working to Ease Burden on Small Businesses that Use Hazardous Drugs

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  • 5:54AM Jul 25, 2013
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The Washington State Department of Labor & Industries recently released Draft Model Program Templates designed to help employers create the hazardous drug control plan required by the Hazardous Drug rule, WAC 296-62-500. Earlier this year we discussed the State’s new rules for the workplace that handles hazardous drugs including chemotherapy agents. Draft Model Programs were […]

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The Global Supply Chain: Risky Business for Pharmaceutical Ingredients

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  • 1:17PM Apr 15, 2013
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By Crystal Morrison, Ph.D. Diversity within the global supply chain may provide competitive benefits for industry, but its complicated nature may also mask risk and liability. Recent headlines regarding adulterated pharmaceuticals have provided a sobering reminder of the importance of supply chain security and quality control. While regulatory agencies are doing what they can to […]

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