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 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
-
ASTM International Committee E11 on Quality and Statistics has approved the last in a series of ASTM standards that preserve military sampling standards that were originally under the jurisdiction of the U.S. Department of Defense. The new standard, ASTM E2910 , Guide for Preferred Methods for Acceptance of Product, preserves MIL-STD-1916 in its original form. ASTM E2910 is under the jurisdiction…, ASTM Committee E11 Next Meeting:, May 8-10, 2013, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Dean V. Neubauer, Corning, Inc., Corning, N.Y., Phone: 607-974-6777; neubauerdv@corning.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 #9317
-
Personal protective equipment manufacturers, material manufacturers and end users with an interest in impact resistance are encouraged to contribute to the development of a proposed new standard on measuring transmitted impact force on protective clothing. The proposed standard, ASTM WK38096 , Test Method for Measuring Transmitted Impact Force Through Materials Used in Protective Clothing, is…, ASTM Committee F23 Next Meeting:, Jan 29-31, 2013, January Committee Week, Jacksonville, Fla., Technical Contact:, Angela Fisher, Wells Lamont Industrial, Palatine, Ill., Phone: 612-940-1316; afisher@wellslamont.com, ASTM Contact:, Ashley Wiand, Phone: 610-832-9551; awiand@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9268
-
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…
-
In many testing laboratories, it can be necessary to qualify a new test method, instrument or lab itself with respect to one or more performance characteristics. One such key characteristic is bias, or mutual agreement of average test results run on the same material. A proposed ASTM standard will aid in the determination of bias equivalency. ASTM WK37659 , Guide for Testing for Bias Equivalency…
-
For several years, ASTM International Committee E11 on Quality and Statistics has been preserving military sampling standards no longer supported by the U.S. Department of Defense. The latest ASTM standard to emerge from this program is ASTM E2819 , Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL. “The reason for preserving military…
-
Interested parties are invited to join in the development of a new proposed standard being developed by ASTM International Committee E11 on Quality and Statistics . ASTM WK32565 , Guide for the Use of Non-Parametric Statistical Methods, is under the jurisdiction of Subcommittee E11.10 on Sampling/Statistics . According to Stephen Luko, statistician, Hamilton Sundstrand, Shared Engineering…, ASTM Committee E11 Next Meeting:, Oct. 26-28, 2011, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Stephen N. Luko, Hamilton Sunstrand, Shared Engineering Services, Windsor Locks, Conn., Phone: 860-654-3447; stephen.luko@hs.utc.com, ASTM Staff Contact:, Christine Sierk, Phone: 610-832-9728; csierk@astm.org Release #8978
-
New Standard for Chemical Permeation Testing Approved by ASTM Personal Protective Clothing CommitteeChemical protective clothing has been widely used to protect skin from health hazards that can be found in the workplace or during a terrorist attack. A new ASTM International standard provides directions in using a computer program, called a permeation calculator, to analyze data following a permeation test, in order to determine when chemicals have gotten inside the clothing. The new standard,…
-
Due to risk of infection from blood-borne pathogens such as human immunodeficiency virus and hepatitis C, hypodermic needle sticks pose a life-safety risk to healthcare professionals, law enforcement officials, sanitation workers and others. A new ASTM International standard addresses the unique mechanics of hypodermic needle puncture as related to protective clothing. ASTM F2878 , Test Method…