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Abstract

A technical safety analysis has been performed on a containment level 2 pilot plant in order to assess an upgrade of the existing facility which should comply with good manufacturing practices (GMP). The results were obtained by employing the hazard and operability (HAZOP) assessment method and are discussed in view of the appropriateness of this procedural tool for low hazard biotechnology applications.

The potential release of microorganisms accounts only for a minor part of hazardous consequences. However, in certain cases the release of a large or medium amount of microorganisms will 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 (SOP) play a prominent role when setting up a safety management concept. 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. .

Additional information

Authors: PETTAUER D, JRC Ispra (IT);VAN DEN EEDE G, JRC Ispra (IT);KÄPPELI O, BATS, Basel (CH)
Bibliographic Reference: Article: Applied Microbiology and Biotechnology (1998)
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