Abstract
My technical work and my STS research are connected primarily through best manufacturing practices and ethical engineering. In my technical project, my team and I construct a process that takes empty fruit bunches, a byproduct of palm oil harvesting, and processes them into acetaminophen. However, since our facility manufactures medicine, there are a plethora of safety and ethical obligations that it needs to fulfill. To gain a better understanding of these obligations, my STS research applies the principles of duty ethics to the disastrous Cutter incident, showing the consequences of failing to follow ethical obligations and laying the groundwork for how engineers must act in the pharmaceutical industry.
My technical work designs a sustainable biorefinery process to produce acetaminophen from empty fruit bunches (EFBs) produced as a byproduct of the palm oil harvesting industry in Malaysia. The process converts lignin, a component of EFBs, into acetaminophen through a series of chemical reactions. This plant-based synthesis route replaces the traditional petrochemical pathway that relies on fossil fuel-derived benzene, offering environmental benefits through reduced greenhouse gas emissions and the utilization of agricultural waste products. The design produces high purity acetaminophen, and the factory operates under strict safety regulations to meet ethical standards for pharmaceutical manufacturing.
My STS research examines Cutter Laboratories, which failed to follow these ethical standards and examines why the company failed under a duty ethics framework. Cutter laboratories were responsible for the production of the polio vaccine in 1955. However, the company failed to adequately inactivate the virus in its vaccine and caused 40,000 polio cases, 200 paralysis cases, and 10 deaths as a result. Using Immanuel Kant's duty ethics framework, my research demonstrates that Cutter violated the categorical imperative. First, Cutter submitted only favorable data to regulators while concealing manufacturing failures issues with inactivation, which cannot be universalized without destroying trust essential to the pharmaceutical industry. Second, Cutter violated patient autonomy by stating "the virus is inactivated" on labels while withholding critical safety information from families and regulators, thereby treating vaccinated children as mere instruments. My research concludes that legal compliance does not equal moral responsibility, and engineers have a duty to disclose known risks regardless of regulatory requirements.
Working on my technical and STS research in tandem helped inform the safety and quality standards of the acetaminophen project. Through my analysis of the Cutter incident, it became clear that there are ethical considerations in pharmaceutical manufacturing that are not encapsulated by regulatory standards. For example, the waste handling and treatment of depleted EFBs was not written in law in Malaysia, but the handling of such waste must be carefully considered to prevent contamination of municipal water plants and local facilities. This work helps inform future projects, as engineers must make themselves aware of regulatory gaps to maintain ethical standards in their work.