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In the field of personal protective clothing, a temperature rating indicates the lowest acceptable air temperature at which an average person would be comfortable when wearing a certain set of clothing. While manufacturers believe that providing temperature ratings is helpful to consumers when they are comparing garments, there have been different methods of testing for a temperature rating. The…
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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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Healthcare workers who inspect radiation protection garments will be the primary users of a proposed new ASTM International standard, WK15823 , Practice for the Fluoroscopic Inspection of Radiation Protection Garments. The proposed practice is being developed by Subcommittee F23.70 on Radiological Hazards, part of ASTM International Committee F23 on Protective Clothing. “Besides visual…
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A proposed new standard is being developed for the industrial radiation processing industry and irradiation research facilities where absorbed-dose measurement is critical. The proposed standard, WK15409 , Practice for Dosimetry in Radiation Processing, is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, which is part of ASTM International…
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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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Two proposed new standards currently being developed by ASTM International Committee F23 on Protective Clothing will each contribute to the safety of protective clothing. Interested parties are invited to participate in the development of both proposed standards, which are WK14247 , Specification for Air-Fed Protective Ensembles and WK14442 , Antimicrobial Activity of Textiles Following Multiple…, WK14247, Specification for Air-Fed Protective Ensembles, Subcommittee F23.30 on Chemicals invites users and manufacturers of air-fed protective ensembles to participate in the development of a proposed new standard WK14247 . This proposed specification would establish design, performance, documentation, labeling and certification requirements for protective ensembles that rely on principal air supply to the wearer via an air line or air filtered…, WK14442, Antimicrobial Activity of Textiles Following Launderings with Bleach, Antimicrobial treatments often are applied to textiles to impart durable efficacy, reducing the survival and growth of microorganisms on the textile. A proposed new ASTM standard, WK14442 , under the jurisdiction of F23’s biological subcommittee, F23.40 , would ensure these antimicrobial agents would continue to work throughout a garment’s life span. “Over the last 10 years, the industry has…
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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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Questions raised at a dosimetry symposium in 1998 have led to the development of a proposed new ASTM International standard, WK13464 , Guide for Performance Characterization of Dosimeters for Use in Radiation Processing. WK13464 is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, part of ASTM International Committee E10 on Nuclear Technology and…
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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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ASTM International Committee F23 on Personal Protective Clothing and Equipment has developed a new standard in response to a United States Food and Drug Administration ruling to change how the marketing of surgical gowns is regulated. The new standard, F 2407 , Specification for Surgical Gowns Intended for Use in Healthcare Facilities, is under the jurisdiction F23’s biological subcommittee, F23.…