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 ###
-
Recent changes in technology are now covered in a significant ASTM International standard used to measure the particle size of metal powders. The standard, ASTM B330 , Test Methods for Estimating Average Particle Size of Metal Powders and Related Compounds Using Air Permeability, is under the jurisdiction of Subcommittee B09.03 on Refractory Metal Powders , part of ASTM International Committee…, ASTM Committee B09 Next Meeting:, April 14-16, 2014, Hollywood, Fla., Technical Contact:, Frank Venskytis, Clayton, N.C., Phone: 919-553-8050; fvastm@embarqmail.com , ASTM Staff Contact:, Katerina Koperna, Phone: 610-832-9728; kkoperna@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9544
-
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 Committee E61 to Maintain and Develop International Standards, ASTM International, one of the largest voluntary standards development organizations in the world, has announced that ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications has been reorganized as ASTM Committee E61 on Radiation Processing . The new main committee will revise and maintain the existing Subcommittee E10.01 standards and will develop new standards that cover…, ASTM Committee E61 Next Meeting:, Jan. 27-29, 2013, Jacksonville, Fla., ASTM Staff Contact:, Joseph Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9231
-
Flow characteristics of fine metal powders are important in filling dies for pressing of powder metallurgy compacts, which are later sintered and sometimes machined into finished parts. The flow rate, as measured by a new ASTM standard, determines the flow necessary for a precise quantity of powder to be introduced into the die. The new standard, B964 , Test Methods for Flow Rate of Metal Powders…
-
Two recently approved ASTM International standards provide user-friendly tests for properties of sintered metallurgy products. The new standards, developed by Subcommittee B09.04 on Bearings, are ASTM B962 , Test Methods for Density of Compacted or Sintered Power Metallurgy (PM) Products Using Archimedes’ Principle, and ASTM B963 , Test Methods for Oil Content, Oil-Impregnation Efficiency and…
-
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…