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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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Three proposed ASTM International standards will provide a base for the evaluation of the antimicrobial efficacy of solid copper materials. The proposed standards are being developed by Subcommittee B05.06, Methods of Test, part of ASTM International Committee B05 on Copper and Copper Alloys . The three proposed standards are: • ASTM WK42235 , Test Method for Efficacy of Copper Alloy Surfaces as…, ASTM Committee B05 Next Meeting:, Oct. 21-23, 2013, October Committee Week, Jacksonville, Fla., Technical Contact:, James H. Michel, Copper Development Association Inc., New York, N.Y., Phone: 212-251-7210; j ames.michel@copperalliance.us, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9439
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A newly approved ASTM copper standard focuses on the mechanical properties of machining brasses. ASTM B981/B981M , Specification for Low Leaded Brass Rod, Bar and Shapes, was developed by Subcommittee B05.02 on Rod, Bar, Wire, Shapes and Forgings , part of ASTM International Committee B05 on Copper and Copper Alloys . “Since 1997, there has been increasing legislation, regulation and voluntary…, ASTM Committee B05 Next Meeting:, April 15-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, Larry Muller, Chase Brass and Copper Co., Montpelier, Ohio, Phone: 419-485-8932; lmuller@chasebrass.com, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9307
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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Honeycomb ceramics, porous with linear hollow channels, are being used worldwide in automotive catalytic converters and as diesel particulate filters for trucks. Flexural testing of this type of ceramics is addressed in a new ASTM International standard, ASTM C1674 , Test Method for Flexural Strength of Advanced Ceramics with Engineered Porosity (Honeycomb Cellular Channels) at Ambient…
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ASTM International Committee B05 on Copper and Copper Alloys has created a new task group, TG9018, which will be focused on the Antimicrobial Applications of Copper and Copper Alloys. The task group was formed following the U.S. Environmental Protection Agency's announcement of its registration of copper alloys as antimicrobial materials with specific health claims. According to James Michel,…
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New Advanced Ceramics Standards from ASTM Cover Fracture Mirror Size Analysis, Tensile Strength DataSubcommittee C28.01 on Mechanical Properties and Performance, part of ASTM International Committee C28 on Advanced Ceramics, has recently approved two new standards, ASTM C1678 , Practice for Fractographic Analysis of Fracture Mirror Sizes in Ceramics and Glasses, and ASTM C1683 , Practice for Size Scaling of Tensile Strengths Using Weibull Statistics for Advanced Ceramics., ASTM C1678 —Bringing Consistency to Fracture Mirror Size Analysis, Fracture mirror size analysis is a powerful quantitative tool for the interpretation of broken ceramic and glass articles. While this type of analysis can be used to determine the stress in a part at the instant of fracture, inspection and interpretation procedures have often varied, resulting in uncertainty in stress estimates. ASTM C1678, Practice for Fractographic Analysis of Fracture Mirror…, ASTM C1683 —Scaling Strength Values, ASTM C1683, Practice for Size Scaling of Tensile Strength Using Weibull Statistics for Advanced Ceramics, provides methodology to convert fracture strength parameters estimated from data obtained with one test geometry to strength parameters representing other test geometries. Stephen Duffy, chair of civil engineering, Cleveland State University, and C28 member, says that companies producing…
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Ceramic and glass companies, as well as universities and government laboratories, will be the primary users of a new ASTM standard that allows for the flexural strength determination of components made in a round shape or after finish machining with minimal waste. The standard, ASTM C1684 , Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature-Cylindrical Rod Strength, was…
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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…