This question drives clients and critical valve makers crazy. There are loads of folks out there asking YOU to answer this question (it seems so logical, after all). Then, when we tell you we don’t know for sure, it kinda makes you the ham in the sandwich, caught between a demand for information and the
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by Tom Moss, Applied Process Solutions First, I would like to thank the Boston Area Chapter of ISPE for honoring me with the second issuance of The Hank Moes Founders Award. It is truly great to be honored by one’s peers and it is really a wonderful thing to see something I started (the Boston
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by Brian J. Uhlenkamp, DCI, Inc.and Ken K. Kimbrel, Central States Industria The most common metallic material of construction for product contact surfaces in BioPharm applications continues to be 316L stainless steel. In more demanding and corrosive environments, higher alloyed Super-Austenitic (6-Moly) stainless steels, such as AL6XN® (N08367) and 254SMO® (S31254) or Nickel-Chrome-Moly alloys such
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What should you expect from vendors? In this article, we offer some philosophical observations on “mission-critical” components that we hope will serve as a guide for managing your manufacturing future. They could change your ideas about the characteristics you should demand of aseptic component makers. They might also give you a concrete idea of what
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Author: Paul L. Sturgill, Sturgill Welding & Code Consulting In any biopharmaceutical application, material specifications are a critical component to the success of the project. Engineering firms specify the materials that must be used based on the process conditions those materials will be exposed to during processing. Vendors like ASEPCO provide products that conform to
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For many of you, the phrase “mission-critical components” might conjure up an image of the gold foil-covered shields found on space satellites or the mil spec parts found in an F-16. But in truth, you are using mission-critical components in your facility right now. In our industry, the combination of product value along with the
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Recently, a customer asked this question: “When issuing a performance specification for a bottom mounted magnetic mixer, what are the critical pieces of information required by the mixer vendor to facilitate the correct sizing and end performance of the mixer?” This is an excellent question and it is often overlooked in the rush to get
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Having been through a few facilities, it always amazes me that they run as smoothly as they do. There’s so much different equipment that is required to make a bioprocess system work, it’s a wonder that people are able to master it all. Of course, it helps if the equipment suppliers provide well-designed equipment. As
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Most of us have some familiarity with the ASME BPE Standard. While you may know of the ASME BPE and you may even know a little bit about the details, you should also know that the Standard is a living document that is constantly evolving to provide the best possible requirements for equipment and fabrication
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