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The SARS-CoV-2 disease has been an ongoing global problem that has taken the lives of many people; thus, producing vaccines is crucial to the fight of this disease. The technical project seeks to solve the issues around the limited supply of vaccines. This is addressed through developing the technical specifications for a chemical engineering pharmaceutical plant to produce COVID-19 vaccines. Additionally, it is imperative that our pharmaceutical plant maintains current good manufacturing practices in order to not only produce sterile vaccines, but also to maintain a safe production environment. The STS project will seek to provide more insight on the importance of maintaining a positive safety culture. This is done by studying the 1988 Piper Alpha oil platform explosion to identify the main contributing factors to the disaster. Together, the technical project and the STS project will provide a greater understanding on how to create an effective vaccine while maintaining process safety in order to end the COVID-19 pandemic. In what follows, I will expand on both the technical and STS project and reflect on the benefits of working on these two projects simultaneously. The ultimate goal of the technical project is to design a rapid, safe, and cost-effective production process for a recombinant spike protein-based SARS-CoV-2 vaccine using the baculovirus expression vector system (BEVS). BEVS uses insect cells to produce the vaccine antigen, enabling the vaccines to be stored at normal refrigeration temperatures. The manufacturing process encompasses upstream, downstream, and formulation and filling. The upstream process involves growing the insect cells, and infecting them with a baculovirus to produce our desired antigen. Downstream processing will include a series of unit operations to recover and purify the protein. In formulation and filling, we will combine the protein in an aqueous solution with excipients, and fill the final vaccine into multi-dose vials. In order to supply vaccines for the remaining unvaccinated global population, this process will produce 400 million vaccine doses per year. In the STS project, I analyze the 1988 Piper Alpha oil platform explosion using Actor-Network theory in order to identify the contributing factors to the disaster that killed 167 people. I argue that a poor safety culture exacerbated by oil production economic pressures led to the destabilization of the Piper Alpha actor-network ultimately resulting in the 1988 disaster. Two rogue actors, safety culture and economic pressure, destabilized Occidental’s goal of producing profitable oil. To support my argument, I analyze evidence from the Cullen Investigation report. This analysis provides a better understanding of what led to the Piper Alpha disaster, in order to effectively balance profit and safety on an offshore oil platform. While the technical project, creating the vaccines, is certainly the best way to prevent the spread of coronavirus, the manufacturing process raises many environmental, health, and safety (EHS) concerns. That is why it is important to additionally study and be aware off all safety and environmental hazards for this manufacturing plant. The STS research highlights the importance of process safety, which has influenced the EHS portion of my technical design. Additionally, designing the pharmaceutical manufacturing plant has shown many of the safety improvements that have been made since the 1988 Piper Alpha disaster. Overall, working on both projects simultaneously I can produce a sterile and effective SARS-CoV-2 vaccine, while maintaining a safe manufacturing environment, in order to end the COVID-19 pandemic.

Professionalization of safety is gaining some interest in international safety literature, including (post)graduate training and education of safety experts. Different from research, there are hardly any publications and discussions on the quality of (post) graduate safety education in the academic safety literature. This article starts with a short historical picture of safety education. After this picture, a description of the ten (post) graduate safety courses involved is presented with a special reference to the assessment of the quality of these courses. It shows that an internal evaluation of quality, like reactions from trainees, and results from examinations, and tests are presently the main quality indicators. Discussions on how quality assessment can be performed has led to an overview of literature on educational objectives and educational models, and possible options for this assessment. The article concludes that the transfer of safety knowledge and skills to companies and organizations is a highly desirable elaboration of the quality concept. But it is also clear that traditional safety indicators can provide no, or only unreliable, information about the degree of this transfer. An overview of possible minor and major accident scenarios of the company or organisation concerned might be a better option, combined with the activities of the trainee to influence and prevent activation of these scenarios., (undefined)

Cancer is a life-threatening illness that has invaded and stolen the lives of billions of people, making cancer drugs such as pembrolizumab critical in the fight against this disease. However, manufacture of such drugs must be carried out such that all parties involved remain unharmed. Examining the ethics surrounding the Piper Alpha oil explosion can apply broadly to any engineering application, including my technical project of designing a pharmaceutical facility for a cancer drug. Pharmaceutical companies are not only responsible for providing safe and accessible medications to society, but they are additionally responsible for their personnel, the environment, and the surrounding community directly affected by the pharmaceutical facilities. Although there is no overlap in technologies between the two projects, the ethical lessons that can be learned from the Piper Alpha disaster can and should be utilized in the context of any technical design, such as a pharmaceutical facility, in order to ensure that those involved with the technology learn to act ethically for the good of the greater whole. The technical report includes the full design of a Merck pharmaceutical facility producing the cancer drug Keytruda, also known as pembrolizumab. This process encapsulates the drug production process beginning with the inoculation of a master cell bank and resulting in the purified drug product ready for intravenous injection. Our capstone team designed the facility to implement a fully integrated, continuous process, in addition to using single-use technology. Making the process continuous offers advantages of higher yield, purity, and efficiency, thus allowing us to drive production costs down, leading to lower drug prices in an effort to make the drug more accessible. Implementing single-use technology indicates that several components of the process will be disposable after a single use, which will decrease the environmental and social impacts of hazardous cleaning chemicals. Overall, the goal of this project was to further our understanding of pharmaceutical processes, while analyzing the feasibility and economics of implementing new pharmaceutical technologies. The STS research paper analyzes the morality of various members involved in the Piper Alpha oil rig explosion. I use the theory of care ethics, developed by Carol Gilligan and Nel Noddings, which focuses on the duty of care two parties owe each other in a relationship, especially when the power dynamic is asymmetrical. My claim is that Occidental Petroleum, the company that owned the Piper Alpha oil rig, was immoral due to their failure to provide adequate care for their personnel, and should therefore be held accountable for the resulting casualties. Specifically, I use evidence from the Piper Alpha investigation to prove how Occidental Petroleum continuously failed to provide care to its personnel. By examining this case study, I hope readers can understand that proper engineering design compliance with rules and regulations should arise naturally when designing from a moral standpoint, rather than forcing design specifications to meet the required standards. Working on both the technical design of a pharmaceutical facility and the Piper Alpha disaster analysis simultaneously has given me tremendous insight into the immense responsibilities engineers carry within society. It is crucial that engineers design with those they owe a duty to care to in mind, such that the final design does not put these parties in harm’s way. When working on the pharmaceutical facility design, I was awestruck at how many opportunities there were for failure, such as the personnel getting injured, the drug not meeting quality control standards, or environmental contamination. As the pharmaceutical company owes a duty of care to its personnel, customers, and environment, simultaneously analyzing morality within the context of the Piper Alpha disaster certainly shed light on the weight our technical design decisions would carry within society.

Exposición panorámica de los principales avances legislativos, de construcción naval y de seguridad marítima desde el siniestro del TITANIC hasta nuestros días.

This paper examines the following aspects of offshore safety in oil and gas production systems before and after the Piper Alpha Disaster: · Regulation/legislation; · Research/risk modelling; · General safety trends. It shows that the change from prescriptive regulation to self-regulation has produced better designs and that the research and risk modelling before and after Piper Alpha cover the same fields but are now more focused. There is clear evidence of a desire to minimize human exposure to risk through automatic systems and devise the safest design option as early as possible, for more detailed development. The evidence points to steady reduction of fatalities and injury rates over at least 15 years, but the highest individual risk is still transport to and from the installation.

Master's thesis in Risk Management The main objective of this thesis has been to re-visit the Piper Alpha accident using the latest version of the FLACS simulation code. In 1988/89 simulations of the gas explosion in the C Module of Piper Alpha were performed by Jan Roar Bakke and Idar Storvik at Christian Michelsen Institute, in conjunction with the investigation after the accident. For these simulations the computer code FLACS was used [1, 2]. In this thesis, the same simulation cases have been looked into, and the results obtained have then been compared to the results from the previous findings in 1988/89. The continuous development of computer technology contributes to better and more accurate analysis tools. For assessing the consequences of gas explosions, FLACS is a well known tool. Improvements in the implementation of FLACS have contributed to increasingly more accurate calculations; becoming more and more consistent with practical experiments. Explosion loads are determined by several factors, among other; Geometry Obstructions Ventilation Wind conditions The new FLACS code allows for a more complex model than the code used for the previous studies, and also for adding effect of wind and ventilation. Therefore, in this thesis the effect of increasing degree of obstruction/congestion and the impact of natural ventilation inside the C Module on the Piper Alpha Platform is discussed. Various scenarios for the leakage dispersion, where leak rate, leak direction and leak position have been varied, are also presented. A total of 21 cases have been simulated in this thesis. The first 15 scenarios that have been simulated in relation to this thesis, are based on the simulations carried out in 1988/89. Further, 6 new cases are dened based on the first 15 cases, and it is for these last 6 simulations that the effects of wind and leak dispersion has been taken into account. The sources for modelling the geometry have not been unambiguous in this thesis; the modelling is based on model photographs and exterior photos of the platform. The continuously development of the FLACS numerical model is illustrated through the first 5 simulation cases in this thesis. For these cases the approximately same geometry model has been generated and used for the same scenarios as those performed in the simulations in 1988/89. The results for the next 10 simulation cases, 11-20, shows that the generated overpressure for a gas explosion in a partly confined area is dependent on the congestion inside the area, as well as the structure and equipment on the outside, and that increased congestion/obstruction increases the overpressure. The new simulations confirmed the findings from the 1988/89 simulations regarding the gas composition and the size of the gas cloud; condensate gives higher overpressure than natural gas for the same geometry and ignition location, and a gas cloud covering 50% of the volume gives a larger explosion than a gas cloud covering 30% of the volume. In this thesis, it was also shown that the generated overpressure were higher for ignition near the wall vs. ignition in the centre of the module, for the same cloud composition and dimension. The 6 last cases illustrates the impact of natural ventilation, leak rate, leak direction and leak position. It was found that a leak rate in the same direction as the natural ventilation at the leakage position inside the module, generated smaller gas clouds than that of a leakage direction in the opposite direction of the natural ventilation. The latter one gave too large gas clouds compared to what was expected. It was observed that the effect of altering the leakage position by just 0.5 metre in the X-direction had a huge impact on the generated overpressure, and so had the leak rate. An increased leak rate (2,7 kg/s vs. 1,7kg/s) led to increased overpressure.