The International Society for Pharmaceutical Engineering (ISPE, http://www.ispe.org), a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new guidance document titled “ISPE Good Practice Guide: Process Gases.”
The guide aims to define current best practices within pharmaceutical manufacturing
applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams, such as nitrogen, oxygen, argon, and compressed air.
The guide focuses on defining cost-effective engineering approaches and practices used to deliver a process gas system for a manufacturing facility in a timely manner that will meet its intended purpose. The guide 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. Food and Drug Administration and the EMA. It promotes a science- and risk-based approach to provide an effective basis for this process, and is intended to align with ICH Q9 and ASTM-E2500 principles.
For more information on the ISPE Good Practice Guide: Process Gases, or to order a copy in either bound or electronic form, visit the ISPE website