(TAMPA, FLORIDA, USA, 27 July 2011) – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, today announced that it 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.
ISPE Good Practice Guide: Process Gases 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 US 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, or to order a copy in either bound or electronic form, visit www.ISPE.org/ispegpg/ProcessGases.
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.