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ASTM International Committee E35 on Pesticides and Alternative Control Agents has begun work on the latest in a series of standards on biofilm. The proposed new standard, WK17813 , Test Method for Quantification of a, Pseudomonas aeruginosa, Biofilm Grown with Low Shear and Continuous Flow Using a Drip Flow Biofilm Reactor, is being developed by Subcommittee E35.15 on Antimicrobial Agents. According to Darla M. Goeres, senior research engineer, Center for Biofilm Engineering, and E35 member, biofilm is defined as microorganisms living in a self-organized cooperative community. These communities, which are embedded in slime and can be…, Pseudomonas aeruginosa, Biofilm Grown with High Shear and Continuous Flow Using CDC Biofilm Reactor; and E2196 , Test Method for Quantification of a, Pseudomonas aeruginosa, Biofilm Grown with Shear and Continuous Flow Using a Rotating Disk Reactor) is that biofilm is grown under low fluid shear close to the air/liquid interface and that the drip flow reactor is a plug flow reactor system, resulting in biofilm that is visible to the naked eye and smooth and slimy in appearance. Biofilm generated in a drip flow reactor could represent those found in a wide spectrum of…
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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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Biofilm, self-organized communities of bacteria that can have both positive and negative effects in a variety of industries, is the subject of a new ASTM International standard, E 2562 , Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow Using CDC Biofilm Reactor. The new standard is under the jurisdiction of Subcommittee E35.15 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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Responding to a new emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments, ASTM International Committee E35 on Pesticides and Alternative Control Agents has begun to develop a proposed new standard, WK12880 , Guide for Evaluation of Clean Room Disinfectants. WK12880 is under the jurisdiction of Subcommittee…
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A new standard developed by ASTM International Committee F37 on Light Sport Aircraft covers the instructions a kit producer must provide to a consumer regarding how to assemble and safely flight-test a recreational aircraft to ensure compliance with applicable ASTM standards. The new standard, F 2563 , Practice for Kit Assembly Instructions of Aircraft Intended Primarily for Recreation, is under…
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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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Executives from the Federal Aviation Administration (FAA) met with ASTM International members and staff at this years Airventure - a premier show and convention in the aviation world, hosted by the Experimental Aircraft Association (EAA). The briefing provided an update to the FAA on the status of ASTMs standards initiatives in the aviation sector. Among the representatives for the…