The International Society for Pharmaceutical Engineering (ISPE) released its ISPE Good Practice Guide: Process Gases, which focuses on international guidelines and regulations for gases used in biopharmaceutical and pharmaceutical manufacturing process streams.
According to ISPE, the new guide aims to define current best practices within pharmaceutical manufacturing applications, specifically regarding 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 an effective process gas system for a manufacturing facility in a timely manner. It also provides information on how to avoid increasing facility installation and operation costs.
ISPE says 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. The guide 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, click here.