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There has been a renewed interest in instrumental qualification and standardization by the fluorescence community over the last 10 years, driven by the increasing number of quantitative chemical assays that use fluorescence detection and the presence of regulations in some of these areas. After revising three test methods for fluorescence instruments, stakeholders decided that a standard guide…
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While drug products must be tested for chemical and physical stability in their market packages, the testing process can be long and expensive. A proposed new ASTM International standard under the jurisdiction of Committee D10 on Packaging will provide a quick and accurate method to minimize the necessary package testing. The proposed standard, WK21601 , Test Method for Measuring Water Vapor…
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While the use of radio frequency identification transponders has become common for inventory tracking purposes, RFID system performance can be affected by product and packaging materials. A new ASTM standard can be used to provide a framework for testing RFID system performance that can be applied to, and compared across, all RFID manufacturer systems in any industrial application that involves a…
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ASTM Committee F10 on Livestock, Meat and Poultry Evaluation Systems has approved a new standard, F2717 , Guide for the Development of Independent Third-Party Verification. The standard, which was developed by Subcommittee F10.20 on Device Performance Criteria, provides an internationally recognized set of guidelines for companies that test the accuracy of livestock, meat and poultry evaluation…
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The need to create a more realistic simulation for the small parcel shipping and handling environment was the impetus for the development of a new ASTM standard, D7386 , Practice for Performance Testing of Packages for Single Parcel Delivery Systems. Subcommittee D10.21 on Shipping Containers and Systems—Application of Performance Test Methods, under the jurisdiction of ASTM International…
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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 D10 on Packaging will present a Distribution Packaging Workshop on April 7, 2008, from 10 a.m. to noon. The workshop, which is being organized by the committee’s university liaison subcommittee, will occur during the Committee D10 meeting at the ASTM committee week in Anaheim, Calif. Workshop topics will include the following: • Single-Parcel Shipping Environment—…
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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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Committee F10 on Livestock, Meat, and Poultry Evaluation Systems invites all interested parties to join in the standards developing activities of a new task group on radio frequency identification (RFID). The new task group, which is under the jurisdiction of Subcommittee F10.20 on Device Performance Criteria, will have its first meeting Nov. 1 at the November Committee Week in Tampa, Fla. 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…