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 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. Micro-organism release accounts only for a minor part of hazardous consequences. As a major part of potential failures result from human errors, Standard Operating Procedures (SOPs) play a prominent role when setting up a safety management concept.
PETTAUER Dietmar;
KAEPPELI Othmar;
1998-06-04
JRC15429
https://publications.jrc.ec.europa.eu/repository/handle/JRC15429,
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