Hazard study 2 guidelines preparation

This guide outlines a typical method for carrying out a process hazard study level 2 for a new or existing chemical process plant. It is based on guidelines originally prepared by IC I in the UK. For a more comprehensive treatment of hazard study procedures reference should be made to the hazard study guides listed in this book. 

The safety and biocompatibility of the dmg delivery system and its components have been extensively tested according to Tripartite Biocompatibility Testing Guidelines (Center for Devices and Radiological Health, 1993). Specifically, these studies have shown that PLA is nontoxic and the hazard potential of NMP is insignificant. Additional preclinical tests to evaluate tissue irritation potential, implantation effects, and biodegradation have been completed for formulations prepared with PLA, PLG, and PLC polymers dissolved in NMP or DMSO. The pharmacokinetics of these formulations have also been tested for specific dmg delivery applications. 

Among the petrochemical industries the increasing concern in safety, led to one of the major industries, the British company ICI, in 1963, to put in place the conception of an analytical method that would allow the study of possible hazards and operability problems, in order to eliminate or correct them, thereby making the facilities and the respective operation safer (Kletz, T. 1999). Since then, this method named as HAZOP (hazard and operability study), has evolved to became the reference for the sector. The International Electrotechnical Commission published lEC 61882 2001—Hazard and operability studies (HAZOP) Application guide, providing guidelines, which became a benchmark since then for the preparation those studies. 

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