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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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One of the goals of Subcommittee E54.05 on Building and Infrastructure Protection is to provide guidance for the design of doors, windows and other opening protectives that are part of the exterior security envelopes of buildings. As one path to achieve that goal, the subcommittee is currently developing a proposed new standard, WK14650 , Test Methods for Forced Entry and Ballistics Resistant (…
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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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An ASTM International task group is developing a proposed new standard, WK11343 , Test Method for Performance Verification of Blast Resistant Trash Receptacles (BRTR). Manufacturers of BRTR and related products, transit and other security organizations that may deploy them, organizations that could conduct testing and other interested parties are welcome to attend a task group meeting from 9:00…
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ASTM International Committee E54 on Homeland Security Applications invites all interested parties to participate in the development of a proposed new standard, WK8908 , Guide for School Preparedness and All-Hazard Response. WK8908 is under the jurisdiction of Subcommittee E54.02 on Emergency Preparedness, Training and Procedures. WK8908 will cover concepts, principles and best practices for all…
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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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A proposed new ASTM International standard will help emergency responders develop succinct, usable emergency response guidance in the event of a radiological event, which may include an intentional release or an attack involving a radiological dispersal device (also known as a “dirty bomb”). The proposed standard, WK7020 , Guide for the Development of a Radiological Emergency Response Playbook,…
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ASTM International, one of the largest voluntary standards development organizations in the world, announced the approval and availability of a new standard for collecting, packaging, and transporting visible powder samples suspected of being biological agents. ASTM E 2458 ,, Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces, is the first standard to address the subject. E 2458 incorporates reference guidance to comply with appropriate federal regulations regarding biosafety and biosecurity. The standard is applicable to nonporous surfaces only., Cooperative Interagency and Stakeholder Effort, The development of a sample collection standard was initiated by the U.S. Department of Homeland Security (DHS) in order to address the problems associated with haphazard sample collection and screening. DHS assigned the National Institute of Standards and Technology (NIST) to coordinate and lead a task group whose charge was to develop a standard protocol for the collection of powders that are…, ASTM Committee E54 on Homeland Security, Currently there are over 500 stakeholders in Committee E 54 on Homeland Security, representing diverse groups including first responders, manufacturers, suppliers, trade and professional associations, and federal, state and local government. The committee was first organized in 2003. E 2458 is the third standard issued by Committee E54 on Homeland Security, and the first standard of Subcommittee…, Two-Step Procedure, E 2458 is a two-step procedure that is performed after an initial risk assessment is conducted and a visible powder is deemed a credible biological threat. The first step of the procedure, or Method A, covers the bulk collection and packaging of the suspicious visible powders from solid nonporous surfaces. Bulk samples are collected and transported in a manner that permits public health and…, Sample Collection Procedure Proven to Work, A study was conducted in March 2006 to validate the reliability of the sampling procedure at the U.S. Army Dugway Proving Ground. The study demonstrated that the sampling procedure can be used by trained Emergency Responders in simulated emergency conditions to consistently recover samples. The study also proved that sufficient number of Bacillus anthracis spores can be detected by Emergency…, after, all bulk samples have been collected. The evaluation study was designed to determine the recovery efficacy on seven environmental surface types that included stainless steel, food-grade painted wood, rubber, tile, concrete, finished wood, and plastic. The study involved six teams that included four National Guard Civil Support Teams (CST), the Navy’s Chemical Biological Incidence Response Force (…, Contacts, ASTM standards are available from Customer Service (610-832-9585); https://www.astm.org/contact/ ) or the ASTM web site store ( www.astm.org ). For further technical information, contact E54.01 Chairman Alim A. Fatah, Program Manager, Chemical Systems & Materials, Office of Law Enforcement Standards, NIST (phone: 301/975-2753; alim.fatah@nist.gov ). The next meeting of Committee E54 is Jan.…
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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…