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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides 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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ASTM International Committee E53 on Property Management Systems has begun developing new standards to address the beginning of a challenging new era for asset managers – the era of lost laptops. Understanding how organizations reached this point – where entities are losing an increasing number of sensitive assets such as computers, some with sensitive information stored in the memory devices – is…
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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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Asset budgets are often the third largest line item (after personnel and information technology) for many organizations. Because of this, asset managers in both the public and private sectors need to present compelling arguments and demonstrate strategic value to core missions in framing asset decisions. With this in mind, ASTM International Committee E53 on Property Management Systems has more…
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Anyone who has ever lost time searching for a set of keys that simply are not where they’re supposed to be will appreciate the larger-scale, though similar concept behind E 2499 , Standard Practice for Classification of Equipment Physical Location Information, a new standard developed by ASTM International Committee E 53 on Property Management Systems. The goal of the standard, which is under the…
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ASTM International standards will play an important role in the National Property Management Associations National Education Seminar, to be held from Aug. 25-Sept. 1, in Minneapolis, Minn. Standards under the jurisdiction of ASTM Committee E53 on Property Management Systems will be the subject of a dedicated track at NES that will include several individual seminars, as well as breakout…
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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…