Search
Advanced search
Filter by category
Filter by committee
Search results
-
ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
-
A proposed new ASTM International standard will provide the electrical power industry with a relatively straightforward test for oxidation stability of natural esters. Natural esters, also known as vegetable oils, can be used as an alternative to mineral oil as an insulating liquid in power transformers and other electrical equipment. The proposed standard is ASTM WK21616 , Test Method for…, ASTM Committee D27 Next Meeting:, Nov. 9-11, 2014, November Committee Week, New Orleans, La., Technical Contact:, Kevin J. Rapp, Cargill Industrial Specialties, Brookfield, Wis., Phone: 262-797-5584; kevin_rapp@cargill.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9618
-
ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
-
A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
-
ASTM grain size is a property written into many specifications for metals, with finer grain sizes generally indicating better mechanical properties, such as formability. While measuring certain materials for such properties can be difficult, electron backscatter diffraction can provide precise determinations as well as give information on grain size distribution and statistics. A new ASTM…
-
A recent revision to ASTM International standard E384 , Test Method for Knoop and Vickers Hardness of Materials, expands the range of its coverage. The standard is under the jurisdiction of Subcommittee E04.05 on Microindentation Hardness Testing, part of ASTM International Committee E04 on Metallography. The revision incorporates ASTM E92 , Test Method for Vickers Hardness of Metallic Materials…
-
ASTM International Committee D27 on Electrical Insulating Liquids and Gases is continuing its work on standards for natural esters with the development of a proposed new standard, WK21616 , Test Method for Oxidation Induction Time of Natural Ester Insulating Fluids by Pressure (PDSC) or Regular Differential Scanning Calorimetry (DSC). The proposed standard was submitted under the jurisdiction of…
-
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…
-
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…
-
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…