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A proposed new ASTM International standard will provide a method for a comparative evaluation of limestone sources available for use in flue gas desulfurization (FGD) applications. The proposed standard, WK20129 , Test Method for Evaluating Limestone for Use in Wet Flue Gas Desulfurization Applications by Reactivity, is being developed by Subcommittee C07.05 on Chemical Tests, part of ASTM…
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A workshop on the role of standards in the emerging field of nanotechnology will be held Oct. 8-9, 2008, at the National Institute of Standards and Technology near Washington, D.C. The workshop, "Enabling Standards for Nanomaterial Characterization," is being co-sponsored by the National Cancer Institute's Nanotechnology Characterization Laboratory, the National Institute of Standards and…
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The battle against cancer is being fought on many fronts. Among the most cutting-edge research efforts are attempts to engineer nanotechnology-based therapies. To aid in this endeavor, the Nanotechnology Characterization Laboratory, part of the National Cancer Institute’s Alliance for Nanotechnology in Cancer and the National Cancer Institute at Frederick, has developed methods for nanoparticle…, E2524, , Test Method for Analysis of Hemolytic Properties of Nanoparticles, -E2524 is a protocol for examining the destruction of red blood cells (hemolysis) that can lead to anemia, jaundice and other issues. All intravenously administered drugs must be examined to determine potential for hemolysis. • , E2525, , Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies, -E2525 describes a method for evaluating nanoparticle stimulation or inhibition of the maturation of certain bone marrow cells (macrophages). A common side effect of anti-cancer drugs is inhibition of this process, and bone marrow cells may be particularly sensitive to nano-scale material. • , E2526, , Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials on Porcine Kidney Cells and Human Hepatocarcinoma Cells, -Because studies have indicated that many nanoparticles are cleared from the body through the kidney or liver, these organs are good choices for target organ toxicity evaluation. E2526 presents a method for evaluation of nanomaterial toxicity by examining effects on kidney and cancerous liver cells. Martin Fritts is senior principal scientist at the Nanotechnology Characterization Laboratory and…
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E56 on Nanotechnology has approved its first standard, E 2456 , Terminology for Nanotechnology. The new standard is under the jurisdiction of Subcommittee E56.01 on Terminology and Nomenclature. Because of the great need for a terminology document that is globally recognized and because of the cooperation of several organizations in making the document a reality,…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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Although ASTM International Committee E56 on Nanotechnology was just established this year, it has already begun an ambitious program of developing new standards. Committee E56 is currently developing the following proposed standards, which deal with environmental safety issues, hemolytic properties and particle size measurement. Interested parties are invited to participate in the development of…, WK8985, Guide for Handling Unbound Engineered Nanoparticles in Occupational Settings, Academic, government and industrial laboratories are currently performing nanotechnology research and development and the scope and breadth of this work is expected to grow dramatically. Manufacturing processes involving nanomaterials have begun and commercially available nano-based products have been introduced. All of this activity in the nanotechnology realm has created the need for the…, WK8997, Practice for Analysis of Hemolytic Properties of Nanoparticles, Subcommittee E56.02 on Characterization has begun working on proposed new standard WK8997, Practice for Analysis of Hemolytic Properties of Nanoparticles. This proposed standard would provide a suitable procedure for establishing the safety of nanoparticulate materials that will be used in vivo , such as nanoparticles for therapeutics and diagnostics. "Nanotechnology products will be used in…, For further technical information, contact Scott McNeil, director, Nanotechnology Characterization Laboratory, Frederick, Md. (phone: 301/846-6939; mcneils@ncifcrf.gov )., WK8705, Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS), Subcommittee E56.02 was formed to answer questions regarding characterization, such as size and shape of materials. Another proposed new standard under the jurisdiction of Subcommittee E56.02 is WK8705, Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS), which deals with the vital issue of size characterization. The purpose of the…