SAFETY ANALYSIS OF CONTAINED LOW-HAZARD BIOTECHNOLOGY APPLICATIONS

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 w ere obtained by employing the hazard and operability (HAZOP) assessmen t method and are discussed in the light of the appropriateness of this procedural tool for low-hazard biotechnology applications. The potent ial release of micro-organisms accounts only for a minor part of the h azardous consequences. However, in certain cases the release of a larg e or moderate amount of microorganisms would not be immediately identi fied. Most of the actions required to avoid these consequences fall in to the realm of operational procedures. As a major part of potential f ailures result from human errors, standard operating procedures play a prominent role when establishing the concept of safety management. Th e HAZOP assessment method was found to be adequate for the type of pro cess under investigation. The results also may be used for the generat ion of checklists which, in most cases, are sufficient for routine saf ety assurance.