A guide intended to define best practices within pharmaceutical manufacturing applications addresses gases such as nitrogen, oxygen, argon and compressed air that come into direct contact with the biopharmaceutical and pharmaceutical process steams.
Released by ISPE, an association of pharmaceutical science and manufacturing
professionals, "ISPE Good Practice Guide: Process Gases" provides
information on how to avoid increasing facility installation and operation
costs. The primary focus of the guide is to address the process of designing,
constructing, commissioning and qualifying a process gas system regulated by international
regulatory authorities, including the U.S. FDA and the EMA. According to ISPE,
it promotes a science- and risk-based approach to provide an effective basis
for this process. It is intended to align with ICH Q9 and ASTM-E2500
For more information on the good practice guide or to order a copy in either
bound or electronic form, visit www.ispe.org.
Process Gases Guide for Pharmaceutical Applications
October 12, 2011