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 ###
-
ASTM International Committee C08 on Refractories will celebrate its 100th anniversary on March 26 during the March 25-26 C08 meetings to be held in St. Louis, Mo., in conjunction with the St. Louis section of the American Ceramic Society. For more information on the March meetings and celebration, contact Kathleen McClung, manager, ASTM (phone: 610-832-9717; kmcclung@astm.org ). To register for…, ASTM Committee C08 Next Meeting:, March 25-26, 2014, St. Louis, Mo., ASTM Staff Contact:, Kathleen McClung, Phone: 610-832-9717; kmcclung@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9578
-
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
-
Research and field experience have shown that fines free of clay and other harmful materials can be non-detrimental, and even beneficial, for concrete properties. A proposed new ASTM International standard will be used to distinguish between harmful and non-harmful fines in construction aggregate. ASTM WK36804 , Test Method for Rapid Determination of the Methylene Blue Value for Fine Aggregate…
-
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…
-
Users of standards involving kinetic parameters need reference materials to qualify individual laboratories and to validate procedures and software. A new ASTM International standard will provide such parameters to accommodate apparatus configurations and kinetic models. ASTM E2781 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis, was developed by…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone:, 302-559-6827; roger.l.blaine@gmail.com ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8893
-
Proposed ASTM Kinetic Parameters Standard Being Developed by Hazard Potential of Chemicals CommitteeA proposed new standard being developed by ASTM International Committee E27 on Hazard Potential of Chemicals will provide needed reference materials for instruments, applications and software used for the evaluation of kinetic data used for hazard evaluation. The proposed new standard, ASTM WK27880 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis,…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone: 302-559-6827; roger.l.blaine@gmail.com, ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8611
-
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…