Abstract

CONTAINED IN VOL. 14.05, 2016 Pertains to the range of manufacturing systems described in Guide E 2500, specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	American Society for Testing and Materials
Pages
ISBN
Committee	E 55