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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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ASTM International Committee F41 on Unmanned Maritime Vehicle Systems will meet on Aug. 17, 2011, at the Walter E. Washington Convention Center in Washington, D.C. The meeting will take place in conjunction with the AUVSI Unmanned Systems North American 2011 Conference. The F41 executive subcommittee meeting will begin at 7:00 a.m. on Aug. 17. in room 149A. In addition, all interested parties are…
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A request from the United States Navy was the impetus behind the development of a new ASTM International standard, E2630 , Test Method for Luminance Ratio of a Fluorescent Specimen Using a Narrow Band Source. The new standard was developed by Subcommittee E12.05 on Fluorescence, part of ASTM International Committee E12 on Color and Appearance. Richard Harold, consultant, Color and Appearance…
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First generation gonioapparent colorants are materials pigmented with metal flakes that change lightness as illumination angles change. Used heavily in automotive coatings, the first generation of gonioapparent materials was covered by ASTM International standard E2194 , Practice for Multiangle Color Measurement of Metal Flake Pigmented Materials, first published in 2003. Now, a second generation…
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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 E12 on Color and Appearance has approved a new standard that describes techniques for planning and analyzing the results of an interlaboratory study conducted for certain test methods within E12. E 2480 , Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method with Multi-Valued Measurands, is under the jurisdiction of Subcommittee…
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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 F41 on Unmanned Undersea Vehicle Systems invites all interested parties to participate in a new task group, F41.90.01 on Unmanned Surface Vehicles. With the addition of this new task group, the name of Committee F41 will be changed to Unmanned Maritime Systems. Task Group F41.90.01 is seeking new members with expertise in unmanned surface vehicles to complement the…
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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…