ASME BPE
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ASME BPE
ASME BPE ( American Society of Mechanical Engineers: Bioprocessing Equipment) is an international Standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by thASME Board of Pressure Technologies The first edition of this Standard was approved as an American National Standard on May 20, 1997. The most recent edition was approved by ANSI on March 21, 2022. New editions of the standard are generally approved and published every two years. Purpose and Scope The ASME Bioprocessing Equipment (BPE) Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required. The Standard typically applies to (a) components that are in contact with the product, raw materials, or product intermediates during manufacturing, ...
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ASME
The American Society of Mechanical Engineers (ASME) is an American professional association that, in its own words, "promotes the art, science, and practice of multidisciplinary engineering and allied sciences around the globe" via "continuing education, training and professional development, codes and standards, research, conferences and publications, government relations, and other forms of outreach." ASME is thus an engineering society, a standards organization, a research and development organization, an advocacy organization, a provider of training and education, and a nonprofit organization. Founded as an engineering society focused on mechanical engineering in North America, ASME is today multidisciplinary and global. ASME has over 85,000 members in more than 135 countries worldwide. ASME was founded in 1880 by Alexander Lyman Holley, Henry Rossiter Worthington, John Edison Sweet and Matthias N. Forney in response to numerous steam boiler pressure vessel failures. Kno ...
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Biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological ...
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ISO 2852
ISO 2852 ''Stainless steel clamp pipe couplings for the food industry'' was an international standard that defines a non-permanent sanitary food-grade piping interconnect method, commonly used in the food processing industry and with dairy farm equipment. The interconnect consists of: * a lip flange on the ends of pipes with a grooved indentation on the flange. * a polymer sealing gasket placed between sections of pipe, squeezed between the flanges. This ring has a raised groove on both sides mating with the indentations of the two pipes on either side. * an enclosing clamp with C-shape clamping sections that cover the outer circumference of the flanges, applying pressure to squeeze the two pipe sections together onto the sealing ring. The clamp also provides structural strength and rigidity to the pipe sections. The combined lip flange and gasket do not impede the flow of fluids through the piping. The clamping system may be permanent, using a hose clamp A hose clamp (hose ...
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Single Use Systems
A disposable (also called disposable product) is a product designed for a single use after which it is recycled or is disposed as solid waste. The term is also sometimes used for products that may last several months (e.g. disposable air filters) to distinguish from similar products that last indefinitely (e.g. washable air filters). The word "disposables" is not to be confused with the word "consumables", which is widely used in the mechanical world. For example, welders consider welding rods, tips, nozzles, gas, etc. to be "consumables", as they last only a certain amount of time before needing to be replaced. Consumables are needed for a process to take place, such as inks for printing and welding rods for welding, while disposable products are products that can be thrown away after it becomes damaged or otherwise unuseful. Etymology "Disposable" is an ''adjective'' meaning something not reusable but is disposed of after use. Many people now use the term as a noun or substant ...
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Biology Organizations
Biology is the science, scientific study of life. It is a natural science with a broad scope but has several unifying themes that tie it together as a single, coherent field. For instance, all organisms are made up of Cell (biology), cells that process hereditary information encoded in genes, which can be transmitted to future generations. Another major theme is evolution, which explains the unity and diversity of life. Metabolism, Energy processing is also important to life as it allows organisms to Animal locomotion, move, grow, and reproduce. Finally, all organisms are able to regulate their own internal environments. Biologists are able to study life at multiple Biological organisation, levels of organization, from the molecular biology of a cell to the anatomy and physiology of plants and animals, and evolution of populations.Based on definition from: Hence, there are multiple Outline of biology#Branches, subdisciplines within biology, each defined by the nature of thei ...
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