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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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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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The rapid growth and variety of rides being developed within the water park industry has created a need for new standards to regulate the design and installation of water slides. While individual states within the United States had created rules and guidelines for water slides, these often varied greatly from each other. A new standard developed by ASTM International Committee F24 on Amusement…
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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.…
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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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A new publication about the performance of protective clothing is now available from ASTM International. STP 1462, Performance of Protective Clothing: Global Needs and Emerging Markets, 8th Symposium , includes 19 peer-reviewed papers that address topics related to the performance of protective clothing for government and industrial workers, first responders, and civilians. A vital resource for…
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Fostering government support for ASTM International Committee F23 on Protective Clothing and other standards developing committees related to protective clothing is the central goal of a new memorandum of understanding recently signed by ASTM International and the National Institute for Occupational Health and Safety. The agreement highlights the role of the NIOSH National Personal Protective…
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ASTM International Committee F24 on Amusement Rides and Devices currently has the following new proposed standards under development:, WK526 Netting, Subcommittee F24.24 on Design and Manufacture is currently developing WK526, Practice for Design, Manufacture, Installation and Testing of Climbing Nets and Netting/Mesh Used in Childrens Play Areas, Safety and Attractions. The purpose of the proposed standard is to reduce life-threatening and debilitating injuries associated with netted areas and attractions. "The amusement industry needed…, WK529 Water Slide Structures, Safety is at the heart of proposed new standard WK529, Guide for Classification, Design, Manufacture, Construction, and Operation of Water Slide Structures. The proposed standard, which is under the jurisdiction of Subcommittee F24.70 on Water Related Amusement Rides and Devices, will apply to water slides installed in public places such as water parks, hotels, resorts, and amusement parks.…, WK1074 Interactive Aquatic Play Equipment, In addition to WK529, Subcommittee F24.70 is also working on proposed new standard WK1074, Practice for Manufacture, Construction, Operations, Maintenance, and Water Quality of Interactive Aquatic Play Equipment. The proposed standard applies to interactive aquatic play equipment located in and around re-circulated and potable water, including swimming pools, activity pools, wave pools, lazy…