Safety analysis of contained low-hazard biotechnology applications

Abstract

A technical safety analysis has been performed on a containment-level-2 pilot plant in order to assess an upgrading of the existing facility, which should comply with good manufacturing practices. The results were obtained by employing the hazard and operability (HAZOP) assessment method and are discussed in the light of the appropriateness of this procedural tool for low-hazard biotechnology applications. The potential release of micro-organisms accounts only for a minor part of the hazardous consequences. However, in certain cases the release of a large or moderate amount of micro-organisms would not be immediately identified. Most of the actions required to avoid these consequences fall into the realm of operational procedures. As a major part of potential failures result from human errors, standard operating procedures play a prominent role when establishing the concept of safety management. The HAZOP assessment method was found to be adequate for the type of process under investigation. The results also may be used for the generation of checklists which, in most cases, are sufficient for routine safety assurance.