ASTM Addresses Machine Life

New standard, which includes packaging equipment, will help users determine the fitness of all systems used for drugs, biologicals, and even medical devices.


Seyer reports that “FDA requested that the International Society for Pharmaceutical Engineering (ISPE) team up with ASTM and develop a consensus standard to support a science- and risk-based approach to meet the regulatory requirement to [ensure that] systems are fit for use prior to manufacturing pharmaceutical products.”

ASTM reports that the standard covers “all elements of pharmaceutical and biopharmaceutical manufacturing systems including facility and process equipment, supporting utilities, associated process monitoring and control systems and automation systems that can potentially affect product quality and patient safety.”

New and existing systems are covered in E 2500. “The guide is applicable throughout the life cycle of the manufacturing system, from concept to retirement,” ASTM reports. It allows for “the implementation of changes to current systems as well as their improvement during operation.”

ASTM International standards are available for purchase. Please call 610/832-9585, e-mail, or visit

ASTM lists Seyer as the contact for technical information. She can be reached at 908/901-8834 or

Committee E55 meets May 6-8, 2008, at the May Committee Week in Denver, CO. For membership or meeting information, contact Pat Picariello, Technical Committee Operations, ASTM International at 610/832-9720 or


No votes yet