Inherently safer design

Kletz, Trevor; Amyotte, Paul

doi:10.1016/b978-0-12-810539-9.00030-6

Cited by 18 publications

(30 citation statements)

References 17 publications

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“…method, it is in the best interest of project teams to find an alternative synthetic route or substitute to mitigate the number of challenges associated with these materials in order to ensure that they can be safely executed at the desired manufacturing scale. Following the principles of inherently safer process design, these types of materials should be substituted with a less hazardous option, if available. If no suitable replacement can be located, ARC testing or the small-scale explosivity screening methods are required.…”

Section: Recommendations Arising From the Oreos Assessmentmentioning

confidence: 99%

Explosive Hazard Identification in Pharmaceutical Process Development: A Novel Screening Method and Workflow for Shipping Potentially Explosive Materials

Sperry

Azuma

Stone

2021

Org. Process Res. Dev.

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When a material is identified as potentially capable of explosive propagation by the Yoshida correlation, process safety scientists have few options for semiquantitatively assessing the hazards associated with the use of that material. Oxygen balance calculations, the Rule of 6, and the United Nations (U.N.) explosive functional group list are commonly employed qualitative/semiquantitative methods to assess explosivity without requiring additional experimental data. In contrast, a full United Nations Transportation of Dangerous Goods testing regimen requires, at a minimum, 2 kg of material for Test Series 1 alone, an excessive amount that is rarely available in early pharmaceutical development. A new assessment, called the O.R.E.O.S. method, has been developed that combines the three traditional methods for screening of explosive properties (Oxygen balance calculations, the Rule of 6, and the Explosive functional group list) with the Onset of decomposition determined by differential scanning calorimetry and the proposed Scale. This new assessment has been applied to known energetic materials that are flagged as potentially capable of explosive propagation by the Yoshida correlation and has been shown to be effective at classifying materials in a scale-dependent manner. The tool is customizable to fit any organization’s internal guidance on handling energetic materials. This assessment should find wide utility in both pharmaceutical development groups and contract research organizations as a means to classify compounds that may require further testing before scale-up or to steer project teams to discover safer alternatives. A brief description of the challenges associated with transporting materials for U.N. Series Testing is also presented with the aim of demystifying the process for obtaining such valuable data.

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Section: Recommendations Arising From the Oreos Assessmentmentioning

confidence: 99%

Explosive Hazard Identification in Pharmaceutical Process Development: A Novel Screening Method and Workflow for Shipping Potentially Explosive Materials

Sperry

Azuma

Stone

2021

Org. Process Res. Dev.

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“…The definition of Inherent Safety used in this paper was coined by Kletz (Kletz & Amyotte, 2010), when he stated the four principles of an inherently safer design. These are:…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…This concept is based on the idea that simple plants have fewer opportunities to fail than complex plants, due to having less equipment, or just simpler equipment. It is considered that in this work, this principle is followed by intensification and substitution, since applying these two usually result in a simpler plant (Kletz & Amyotte, 2010).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

OFISI, a novel optimizable inherent safety index based on fuzzy logic

Vázquez

Ruiz‐Femenia

Caballero

2019

Computers & Chemical Engineering

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Highlights Novel index based on fuzzy logic to assess the inherent safety of a piece of equipment or plant.  Disjunctive programming applied to the assessment of the inherent safety of a system.  Non-linearities can be reduced to the objective function only.  It can be easily modifiable to the decision maker preferences by weighting the different parameters.

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“…Chemical engineers also understand well the basis of Principle II, which they refer to as IST, Inherently Safer Technology. 12,13 Ever since the 1920s, it has been known that AN with a calcium carbonate additive, known commercially as calcium ammonium nitrate (CAN), is much less sensitive to initiation and, if forced into explosion, is likely to explode with much less explosive power. Such a safer product, or equivalents thereto, is required in a number of European countries, and the record indicates that there has not been a single explosion of CAN in storage or transport and, of course, no fatalities from explosion.…”

Section: The Needed Safety Measuresmentioning

confidence: 99%

The West, Texas, ammonium nitrate explosion: A failure of regulation

Babrauskas

2017

Journal of Fire Sciences

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On 17 April 2013, the West Fertilizer Company’s ammonium nitrate storage building exploded, killing 15 persons and injuring over 200. Numerous Federal and State agencies regulated the facility. But none of the agencies demonstrated a viable understanding of what is liable to cause accidental ammonium nitrate explosions, nor what is needed to prevent these. Specifically, none of them recognized the fact that ammonium nitrate fertilizer explosion accidents, when they occur, are inevitably the consequence of an uncontrolled fire and that such fires can be precluded by well-known fire safety measures. In fact, existing regulations have generally focused on everything but features needed to make such storage facilities incapable of sustaining an uncontrolled fire. Ammonium nitrate manufacturers, however, did have technical knowledge concerning safety and were aware of the ineffectiveness of governmental regulations. Espousing proper Product Stewardship principles by the manufacturers would have precluded selling dangerous chemicals to buyers who cannot safely store them.

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Inherently safer design

Cited by 18 publications

References 17 publications

Explosive Hazard Identification in Pharmaceutical Process Development: A Novel Screening Method and Workflow for Shipping Potentially Explosive Materials

Explosive Hazard Identification in Pharmaceutical Process Development: A Novel Screening Method and Workflow for Shipping Potentially Explosive Materials

OFISI, a novel optimizable inherent safety index based on fuzzy logic

The West, Texas, ammonium nitrate explosion: A failure of regulation

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