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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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In many testing laboratories, it can be necessary to qualify a new test method, instrument or lab itself with respect to one or more performance characteristics. One such key characteristic is bias, or mutual agreement of average test results run on the same material. A proposed ASTM standard will aid in the determination of bias equivalency. ASTM WK37659 , Guide for Testing for Bias Equivalency…
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For several years, ASTM International Committee E11 on Quality and Statistics has been preserving military sampling standards no longer supported by the U.S. Department of Defense. The latest ASTM standard to emerge from this program is ASTM E2819 , Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL. “The reason for preserving military…
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Interested parties are invited to join in the development of a new proposed standard being developed by ASTM International Committee E11 on Quality and Statistics . ASTM WK32565 , Guide for the Use of Non-Parametric Statistical Methods, is under the jurisdiction of Subcommittee E11.10 on Sampling/Statistics . According to Stephen Luko, statistician, Hamilton Sundstrand, Shared Engineering…, ASTM Committee E11 Next Meeting:, Oct. 26-28, 2011, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Stephen N. Luko, Hamilton Sunstrand, Shared Engineering Services, Windsor Locks, Conn., Phone: 860-654-3447; stephen.luko@hs.utc.com, ASTM Staff Contact:, Christine Sierk, Phone: 610-832-9728; csierk@astm.org Release #8978
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Measurement systems analysis is an important topic in statistics and quality for engineering, manufacturing, laboratory practice and business process applications. A new ASTM International standard, ASTM E2782 , Guide for Measurement Systems Analysis (MSA), covers many core issues of MSA. ASTM E2782 was developed by Subcommittee E11.20 on Test Method Evaluation and Quality Control, under the…
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Discussions concerning how easily test results for dimension stone test specimens can be influenced by improper or nonuniform preparation methods have led to the ongoing development of a proposed new ASTM International standard. The new standard, ASTM WK31179 , Practice for Selection and Preparation of Dimension Stone Test Specimens, is being developed by Subcommittee C18.08 on Selection of…
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Petrography is routinely performed on dimension stone for many construction projects in which new stone is being used, and it is often required in technical specifications. In order to facilitate this process, ASTM International Committee C18 on Dimension Stone has developed a new standard, ASTM C1721 , Guide for Petrographic Examination of Dimension Stone. The new standard is under the…, ASTM Committee C18 Next Meeting:, April 21-22, April Committee Week, St. Louis, Mo., Technical Contact:, Michael Scheffler, Wiss, Janney, Elstner Associates Inc., Northbrook, Ill., Phone: 847-272-7400; mscheffler@wje.com, ASTM Staff Contact:, Jeff Adkins, Phone: 610-832-9738; jadkins@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8432/Dec2009
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With the proposed new standard, WK11023 , Practice for Life and Reliability Testing Based on the Exponential Distribution, ASTM International Committee E11 on Quality and Statistics is continuing its program of preserving U.S. government military standards on acceptance sampling. WK11023 is an adaptation of the DoD quality control and reliability handbook document H-108, Sampling Procedures 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…