What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support...
Although other industry publications have explored the effect of surface finish on biofilm formation, background data indicating that imperfections exceeding the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standard are detrimental to chemical cleaning performance...
As part of their quality risk management (QRM) programs, many biopharmaceutical manufacturers have made deliberate efforts to classify systems, equipment, and components by their potential to affect product quality. In assessing these risks, it is...