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Outbreaks of the H1N1 influenza this year have increased the public’s awareness and use of leave-on hand antiseptics, popularly known as hand sanitizers. ASTM International Committee E35 on Pesticides and Alternative Control Agents is now developing a proposed new standard that will measure the antibacterial activity of hand sanitizers on people’s hands. ASTM WK23789 , Test Method for Evaluation…
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Biofilm, which is defined as microorganisms living in a self-organized cooperative community, is still under the radar for many industry, medical, professional and regulatory agencies. A newly approved ASTM International standard is the latest in a series of biofilm standards being developed by Committee E35 on Pesticides and Alternative Control Agents. The new standard, E2647 , Test Method for…
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ASTM International Committee E35 on Pesticides and Alternative Control Agents has now published the last in a series of three ASTM International standards that address the activity of hand hygiene agents against microbes that can be transmitted via contaminated hands. Subcommittee E35.15 on Antimicrobial Agents developed the new standard, ASTM E2613 , Test Method for Determining Fungus-…
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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…