ISPE Releases Good Practice Guide On Process Gases
July 28, 2011
Guide focuses on international guidelines and regulations for gases used in biopharmaceutical and pharmaceutical industries.
Pharmaceutical science association ISPE has released a new guidance document that defines best practices within pharmaceutical manufacturing applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.
The document, titled “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 Food and Drug Administration 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.
Many facilities handle dangerous processes and products on a daily basis. Keeping everything under control demands well-trained people working with the best equipment.
Enhance the training experience and increase retention by training hands-on in Emerson's Interactive Plant Environment. Build skills here so you have them where and when it matters...
See how Rosemount™ 625IR Fixed Gas Detector helps keep workers safe with ultra-fast response times to detect hydrocarbon gases before they can create dangerous situations.
