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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 market growth and wide acceptance of glass mat gypsum panels has led to the development and approval of a new ASTM International standard. C 1658/C 1658M , Specification for Glass Mat Gypsum Panels, is under the jurisdiction of Subcommittee C11.01 on Specifications and Test Methods for Gypsum Products, which is part of ASTM International Committee C11 on Gypsum and Related Building Materials…
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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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A proposed new standard being developed by ASTM International Committee B09 on Metal Powders and Metal Powder Products offers a solution to the challenge of handling and characterizing very fine powders. Subcommittee B09.02 on Base Metal Powders is developing the proposed standard, WK13023 , Test Method for Determination of Tap Density of Metallic Powders by a Constant Volume Measuring Method. …
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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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Conventionally processed powder metallurgy materials often exhibit open microporosity at the surface. While it is a natural part of the process, this microporosity can affect the measurement of surface finishes. To cover this and other issues that arise from measuring the surface finish of powder metallurgy, ASTM International Committee B09 on Metal Powders and Metal Powder Products has developed…
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Dried blood represents the greatest challenge to cleaning surgical instruments. To meet this challenge, ASTM International Committee D12 on Soaps and Other Detergents has developed a new standard, D 7225 , Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. The new guide is under the jurisdiction of Subcommittee D12.16 on Hard Surface Cleaning. Water-soluble components of…
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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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Although abuse-resistant gypsum panel products have been on the market for sometime, until recently, there was no standard way to evaluate or classify their various abuse-resistant properties. However, a new standard developed by ASTM International Committee C11 on Gypsum and Related Building Materials and Systems, now fills this need. The standard, C 1629, Classification for Abuse-Resistant…