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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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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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ASTM International Committee A01 on Steel, Stainless Steel and Related Alloys invites interested parties to participate in a revision and update of ASTM standard E 527 , Practice for Numbering Metals and Alloys (UNS). The standard is under the jurisdiction of the Committee A01 editorial subcommittee A01.91. E 527 provides the basis for the practice of the Unified Numbering System for all major…
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ASTM International Subcommittee A01.19 on Sheet and Strip Steel has made three significant changes to ASTM standards under its jurisdiction. The changes are: • Reporting of boron levels made mandatory; • Changes to size limitations of general requirements and product standards for hot rolled material; and • Addition of grades 90 and 100 for hot rolled sheet and strip products. Subcommittee A01.19…, Boron Reporting, Boron is often added to low carbon steels to achieve lower hardness and increased formability; however, the mechanical properties of cold reduced and annealed material produced from hot rolled coils containing boron are affected by its presence. The differences may or may not be desired, but the effects are important and cold rolled steel manufacturers need to be informed of the presence of…, Size Limitation Changes, The general requirements for hot rolled sheet and strip products are spelled out in Standards A 568/A 568M , Specification for Steel, Sheet, Carbon, Structural, and High-Strength, Low Alloy, Hot-Rolled and Cold-Rolled, General Requirements for, and A 635/A 635M , Steel, Sheet and Strip, Heavy-Thickness Coils, Hot-Rolled, Carbon, Structural, High-Strength Low-Alloy, and High-Strength Low-Alloy…, Ultra-High Strength Steel Grades, ASTM standards A 1011/A 1011M and A 1018/A 1018M were changed to include grades with 90 and 100 ksi [620 and 690 MPa] minimum yield strength. These grades have the designation ultra-high strength (UHSS) as a way to differentiate them from the high strength low alloy with improved formability (HSLAS-F) designation. The UHSS grades may achieve their high strength by some measure of transformation…
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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…
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The new online "Passport to Steel" now available from ASTM International provides the latest data on more than 50,000 steels with the ability to find comparable worldwide steel standards from organizations around the globe. Several search options, including product forms and alloy groups, make it easy to find needed information quickly. In addition, a Reference Center provides additional related…
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A proposed new standard currently being developed by ASTM International Committee F01 on Electronics will prove to be useful to the tantalum sputtering target industry. The proposed standard, WK9490, Test Method for Reporting Crystallographic Orientation of Sputtering Target Materials, is under the jurisdiction of Subcommittee F01.17 on Sputter Metallization. "The tantalum sputtering target…
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ASTM International Committee F01 on Electronics is currently developing a proposed new standard that will provide uniformity in the values reported for oxygen content in aluminum alloys used for sputtering targets in the manufacture of integrated circuits. The proposed standard, WK9120, Determination of Oxygen in High Purity Aluminum and Alloys in High Purity Aluminum Base by Inert Gas Fusion…