By Jeff Clark, 7P Solutions™, LLC
Today's global transportation industry must confront daily challenges associated with managing regulatory changes and requirements around the world. In addition to the ever changing country regulations, companies providing services to the pharmaceutical industry also face Good Distribution Practices (GMP-GDP) regulations. As if this weren't enough to keep them busy during their daily routines, cargo theft must also be top of mind. Cargo thieves today use many tactics when looking for shipments to steal, and despite the current laws in place, the reward far exceeds the risk involved.
By Hemi Sagi, Director, ATC, Inc.
Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications. As product leakage is typically a micro-flow phenomenon, there are difficulties in applying relevant tools for testing, correlating, and analyzing leak tightness during product manufacturing and quality control.
By Stephen E Szabo Ph.D., Manager Applications Development, Beckman Coulter, Inc.
Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other byproducts.
By Michael Gotz, QuickSTAT
In the previous blog post, "Infectious Biologicals Category A and B — Classification Guidelines," I provided definitions of infectious biologicals in categories A and B, and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.
By Brian Kohr, President and CEO, CSafe
Global sourcing is a 'business-essential' that continues to be of increasing importance to life sciences companies. As manufacturers adapt to changing market conditions, consolidate their operations, and focus thought leadership to work as one company across borders, continents, and markets, the drive to make cost and efficiency savings becomes ever more demanding.
By Maik W. Jornitz, Vice President, G-CON LLC
Since the introduction of single-use technologies into the biopharmaceutical processes in the early 1990s, a multitude of supplier companies mushroomed. The result is that these vendors market many unique single-use product designs, which makes it a chore for an end user to choose and to find a second supply source. The debate is whether single-use systems can be standardized or not. It is an intense debate, as some end users believe standardization restricts their process needs, and most vendors think that they would lose their competitive edge if they cannot customize their assemblies.
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit www.INTERPHEX.com.