Affiliated Industry Groups

ASME-BPE

American Society of Mechanical Engineers – Bioprocessing Equipment

ASME-BPE is a set of internationally recognized engineering standards that defines requirements for the design, materials, fabrication, inspection, testing, and documentation of equipment and components used in biopharmaceutical and other high-purity processing systems.

ASTM

ASTM International — Committee E55

ASTM International Committee E55 is responsible for developing standards related to manufacturing equipment used in pharmaceutical and biopharmaceutical processes.

E55 develops a family of standards covering pharmaceutical and biopharmaceutical manufacturing equipment and systems.

BPSA

Bio-Process Systems Alliance

Bio-Process Systems Alliance (BPSA) is an industry collaboration focused on developing common approaches and best practices for single-use systems in biopharmaceutical manufacturing.

Unlike ASME-BPE, BPSA is not primarily an engineering code or regulatory standard. It is better thought of as an industry group that develops guidance and recommendations to help biopharmaceutical manufacturers and suppliers address common problems associated with single-use technologies.

ISPE

International Society for Pharmaceutical Engineering

International Society for Pharmaceutical Engineering (ISPE) is a professional organization that helps the pharmaceutical and biopharmaceutical industry design, build, operate, and improve manufacturing facilities and processes.