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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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Understanding how blood within a human body will interact with any substance with which it comes in contact is a crucial part of any medical process. A new practice recently approved by ASTM International Committee F04 on Medical and Surgical Materials and Devices is one of a series of standards that evaluates the complement activating properties of solid materials intended for use in contact…
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ASTM International Committee C24 on Building Seals and Sealants invites interested parties to participate in the development of a proposed new standard that will use photographs to illustrate various types of sealant failures. WK11731 , Guide for Diagnosing Sealant Failure by Comparison to Reference Photographs, is under the jurisdiction of Subcommittee C24.10 on Specifications, Guides and…
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A new standard, developed by ASTM International Committee F04 on Medical and Surgical Materials and Devices, establishes performance requirements for single-use, enteral feeding devices with retention balloons. These devices are used by medical professionals to provide nutrition or administer medication to patients through a natural orifice (nasal, oral, transluminal) or through a surgically…
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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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ASTM International Committee F04 on Medical and Surgical Materials and Devices is now developing a proposed new standard, WK8619, Test Method for the Measurement of Crystallinity and Melting Point of Ultra High Molecular Weight Polyethylene via Differential Scanning Calorimetry. The proposed test method, under the jurisdiction of Subcommittee F04.15 on Material Test Methods, will focus on the…
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ASTM International Committee C24 on Building Seals and Sealants is currently working to fill a need for a weatherproofing sealant field test standard. The result, proposed standard WK7800, Guide for a Non-Destructive, Continuous, Field Test of Installed Weatherproofing Sealant, features a field test that has been used by sealant professionals for years, but has not, up to this point, been…
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ASTM International Subcommittee F04.35 has recently undergone a name change. Formerly known as F04.35 on GI Endoscopes, the subcommittee, which is under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, is now known as Gastroenterolgy (GI). The name change indicates a broadening of the scope of activities for the subcommittee. James Bardwell, Leading Medical…
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ASTM International Committee C24 on Building Seals and Sealants is now working on a proposed new standard, WK6920, Fatigue Resistance of Structural Silicone. The standard, which is under the jurisdiction of ASTM Subcommittee C24.20 on General Sealant Standards, is intended to serve as an enhancement to current performance requirements for structural silicones and to help users ascertain that…