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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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Vapor intrusion from contaminated soil and groundwater into structures can potentially create significant liability and have a material impact on property value. Because of this, accurately determining whether a property has vapor intrusion issues is a concern for property owners, prospective purchasers and environmental professionals conducting due diligence. ASTM International Committee E50 on…
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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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Subcommittee D30.05 on Structural Test Methods, part of ASTM International Committee D30 on Composite Materials, has been standardizing a series of methods that are related to the analysis and substantiation of mechanically fastened joints composed of composite materials. The latest in this series of standards, D 7332/D 7332M , Test Method for Measuring the Fastener Pull-Through Resistance of a…
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Information on light nonaqueous-phase liquids and their impact on the environment has grown significantly in the last 20 years. This accumulation of knowledge means that different remediation strategies are now available for sites that contain these substances. In order to facilitate decision making, ASTM International Committee E50 on Environmental Assessment has developed a new standard, E 2531…
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ASTM International Committee E50 on Environmental Assessment, Risk Management, and Corrective Action is seeking participation in the development of a proposed new standard, WK15256, Guide for Investigation of Petroleum Underground Storage Tank Equipment Problems and Releases. The proposed guide, under the jurisdiction of Subcommittee E50.04 on Corrective Action, is intended to assist with the…
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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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Mold, or even the prospect of mold, can create a level of fear and misperception that can have a significant negative impact on all phases of the real estate market. However, in an effort to replace fear with facts, ASTM International’s Committee E50 on Environmental Assessment, Risk Management, and Corrective Action has developed a new standard, E 2418 , Guide for Readily Observable Mold and…
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An ASTM International environmental assessment standard has recently undergone major revisions to reflect relevant changes in federal law. The standard, E 1528 , Practice for Limited Environmental Due Diligence: Transaction Screen Process, is under the jurisdiction of Subcommittee E50.02 on Real Estate Assessment and Management, which is part of ASTM International Committee E50 on Environmental…