A structural approach to the HAZOP – Hazard and operability technique in the biopharmaceutical industry

Abstract

Recently, the use of analytical techniques to identify, assess and address risks within the pharmaceutical industry is increasing from the initial and operating phases until the final use of products aiming to eliminate or reduce the severity of deviations. The hazard and operability studies – HAZOP establish that accidents are the result of failure modes in process variables out of operational parameters. In this paper, the HAZOP methodology was used to assess risks in the system for recombinant protein production where a multidisciplinary group used the brainstorming strategy to identify the risk level and deviations in nodes defined by functionality in the system. Nineteen critical nodes were identified, deviations were established in based on knowledge, and experience by the group, thus precluded the need of deviation's records to estimate frequency and impacts of events. It was also shown that in the pharmaceutical industry the most-critical risks are those that have adverse impacts on production like partial and total losses and when noncompliance of regulations are involved. The HAZOP risk assessment tool can be easily followed by people who are interested in starting to use this technique to improve the security environment within the institution and when required by regulatory agencies.