Articles by Benjamin Romero
Benjamin Romero is a Senior Engineer in the Pharmaceutical & Packaging Engineering department of Genentech. He has over 12 years of regulated packaging experience, most of which focused in the field of thermal package design, validation and manufacturing for the biopharma industry. He has been deeply involved in most areas of cold chain packaging including insulation, phase change material science, electronic temperature monitors, and predictive simulation. His work in the field of cold chain has yielded a US patent, as well as peer recognition in the form of a 2004 IOPP Ameristar, and WPO Worldstar awards in the pharmaceutical category. He has a BS in mechanical engineering from Stevens Institute of Technology, and is a CPP (IOPP Certified Packaging Professional).
Temperature profile selection for cold chain qualification is a topic of much discussion for the pharmaceutical industry. A temperature profile describes the external temperatures used to challenge a thermal shipper in a laboratory test, therefore providing evidence of performance when testing against extreme conditions. The question is what should these extreme conditions be to fully represent...Full Article »
The nomenclature used for describing testing of cold chain packaging used to demonstrate its performance is somewhat controversial. Here we discuss Qualification and Validation, the two most popular terms used to describe such testing. Validation is documented testing, under highly controlled conditions , that demonstrates that a process consistently produces a result meeting pre-determined...Full Article »Events of Interest