Aims to define best practices regarding gases used in pharmaceutical processes
ISPE, the International Society for Pharmaceutical Engineering, headquartered in Tampa, Florida, has released a new guide to the use of gases in pharmaceutical manufacturing.
The ISPE Good Practice Guide: Process Gases aims to define current best practices regarding gases that come into direct contact with 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. It 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 US FDA 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.