Abstract
Introduction: The Hazard and Operability Study is considered a feasible tool to assess risks, where complex technologies, require new strategies to guarantee efficiency, safety, and quality of products. Objective: To perform a Hazop publications review, to establish the state of the art, current procedures and perspectives in the pharmaceutical industry. Method: Hazop methodology and improvements to satisfy actual needs were structured. Subsequently, its application and integration with other risk tools, and experts systems, were analyzed to define the current approach and future perspectives. Results: The review allowed the understanding where models, simulations and specialized software offered adequate support to assess risk in current complex processes. In addition, an efficient definition of causes and consequences depends of expert systems, where simulations acquire experience through the creation of databases, reducing the need of specific process knowledge, which is a typical limitation of the conventional Hazop methodology. Conclusions: A review of the Hazop stateof- the-art highlighted the importance to assess risks within the process industry. However, the use of new technologies designed to meet regulatory affairs to guarantee safety and quality principles would require the ongoing improvement of the Hazop methodology, restricting the dependence of specialists, and increasing the use of expert systems.
Highlights
The Hazard and Operability Study is considered a feasible tool to assess risks, where complex technologies, require new strategies to guarantee efficiency, safety, and quality of products
This methodology is widely used in the process industry to identify and assess failures that may lead to potential hazards for the personnel and equipment involved in the process, as well as to failures that prevent an efficient operation or are responsible for abnormal operations
Since it was created in the mid-1970s, the hazard and operability studies (Hazop) methodology has been widely employed in the process industry as a reliable tool for risk assessment
Summary
The fact that the pharmaceutical industry follows one of the highest standards of regulations at national and international levels, because of the impact its products have on human health, is well known. The application of such standards is not an easy task to carry out, because only process engineers and managers involved directly in the process or similar facilities can understand the scope and fundament of such regulations and the impact on their processes when applied[9] This is how the hazard and operability studies (Hazop) provides to the group of specialists a structured procedure to develop a risk analysis systematically and comprehensively[10]. Hazop methodology can be defined as a structured and systematic process analysis, which can be applied in early stages of the project such as conception and basic steps until operational and post-operation stages This methodology is widely used in the process industry to identify and assess failures that may lead to potential hazards for the personnel and equipment involved in the process, as well as to failures that prevent an efficient operation or are responsible for abnormal operations.
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