The ISPE Glossary of Pharmaceutical and Biotechnology Terminology
is the result of many years of gathering material from sources such as scientific journals, industrial
magazines, professional organizations, the world wide web, industry seminars, company guides, vendor and
manufacturer information, national and international codes, and diverse individuals. This compilation of
abbreviations, acronyms, and terminology is a reference for engineers, designers, technicians, owners,
contractors, and others in the pharmaceutical and biopharmaceutical industries. It includes terms used in
water treatment, welding, metallurgy, medicine, biology, chemistry, computer technology, manufacturing
processes, HVAC, etc.
The Glossary includes terms from the following sources:
About the Author/Editor
Ms. Michelle M. González - Senior Principal Corporate Engineer - Director, Amgen Inc. (Retired) has had extensive experience in leadership activities dealing with facilities and process systems design, facilities engineering, and management of projects. Since relocating to the United States, she has held technical positions of increasing responsibility in mechanical and process engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen.
Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She has been a regular lecturer at the Stanford School of Engineering, and holds professional memberships in the American Institute of Chemical Engineers (AIChE), and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standard, where she serves as Chair of the BPE's Subcommittee on Surface Finishes, voting member of the Executive and Main Committees, as well as the Certification, and Dimensions & Tolerances Subcommittees.
Ms. González is also an active member of ISPE where she has been a speaker, a member of the Membership Committee (MSC), the North America Educational Committee (NAEC), and the Body of Knowledge Committee (BOKC); President of the Greater Los Angeles Chapter (2007-2008), and a participating member on the preparation of the ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing Facilities Baseline® Guide, the Packaging, Labeling and Warehou sing Operations Baseline® Guide, the Laboratories Baseline® Guide, and the revision of the Water & Steam Baseline® Guide. Ms. González has authored various technical papers dealing with materials of construction for the biopharmaceutical industry including "single use" products technology; facilities programming, pilot plants, and biotechnology process systems.