A Novel Proposal To Advance The Discipline And To Quantitatively Safeguard Important Hygienic Bio-Processes

Abstract

A novel proposal that will significantly advance the discipline of chemical engineering, through an improved understanding of unanticipated process risk, and which will safeguard risk in hygienic bio-processing of foods, water and wastes is presented and illustrated. The proposal builds on established chemical engineering unit operations principles. If adopted by the discipline a major outcome would be to expand the current knowledge base and scientific understanding of process risk. This is because a key insight is to show that an accumulation and combination of a series of indiscernible changes in otherwise well-operated plant parameters can lead unanticipatedly in one-direction and leverage highly significant, and sometimes catastrophic, changes in process or product. Currently bio-process engineers are limited to largely ineffective sensitivity analyses or semi-quantitative assessments such as HAZOP (HAZard and OPerability), HACCP (Hazard Analysis Critical Control Point) or Reliability Engineering (i.e. to "fail well"). Additional outcomes would include new technology and components to simulate the unanticipated risk of failure of hygienic processes in a novel library of risk-modules involving microbial growth and death. These new modules longer term will be able to be coupled with existing commercial design software for e.g. Aspen Plus® or Batch Process Developer® to provide significantly more powerful design and assessment techniques and tools than are currently used. These outcomes could then be used to quantitatively underpin new regulatory requirements for future bio-process plant and systems at the design, and operational stages and add intelligent and sophisticated new simulation capability to the discipline.