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A revision to an important ASTM nanotechnology standard incorporates a large-scale interlaboratory study that took place in 2008. The revised standard, ASTM E2490 , Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS), is under the jurisdiction of Subcommittee E56.02 on Characterization: Physical, Chemical and Toxicological…
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Once approved, a proposed new ASTM standard would provide the U.S. Food and Drug Administration and personal lubricant manufacturers a means to evaluate the effect of a lubricant on the physical integrity of condoms. No standard currently exists for this type of testing. Manufacturers of condoms and rubber gloves as well as personal lubricants are welcome to join in the development of ASTM…
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The growing number and severity of healthcare association infections has increased interest in standardization efforts for antimicrobial gloves. In order to explore this area, ASTM International Committee D11 on Rubber has created a new task group on antimicrobial medical gloves. Glove suppliers, manufacturers and distributors, as well as contract test labs, government agency…
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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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Responding to requests from the food service industry, ASTM International Committee D11 on Rubber has developed and approved a new standard, D7329 , Specification for Food Preparation and Food Handling (Food Service) Gloves. The new standard, under the jurisdiction of Subcommittee D11.40 on Consumer Rubber Products, will serve as a referee and guide to glove manufacturers, distributors and the…
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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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Testing for potent allergens in rubber is the purpose of a proposed new ASTM standard. WK16334 , Test Method for the Immunological Measurement of Four Principal Allergenic Protein (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products, is being developed by Subcommittee D11.40 on Consumer Rubber Products, part of ASTM International Committee D11 on Rubber. According to Timo Palosuo and…
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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…