(53aa) Towards an Inherently Safer Bio-Processing Industry

The Bhopal gas tragedy is regarded as one of the worst disasters in chemical processing industries. The consequence radius of this disaster was determined to be 7 km from the source of the incident. However, an equally disastrous failure in bioprocessing industries is the Cutter incident in 1955. Although the consequences of this incident were relatively less severe as compared to the Bhopal gas tragedy, the impact of this incident was felt over five Western and mid-Western USA states making the radius of impact of Bhopal disaster seem minuscule. The incident involved inadvertently injecting more than 200,000 children with live virulent polio virus that resulted in 40,000 cases of Polio accounting to 200 cases of permanent paralysis and 10 fatalities. This incident highlights the need to analyze the scenario of process safety in bioprocessing industries as failure in these industries can not only have an adverse effect on the employees involved and the surrounding population of the processing facilities, but can affect the entire consumer population of the manufactured products, making the societal risks associated with these processes equal (or even greater) than the conventional chemical/refining processes.

The bioprocessing industry is regarded as one of the fastest growing sectors with an estimated compound annual growth rate of 8.6%. In the year 2015, the global market for biopharmaceuticals alone was valued at USD 176.9 billion. Although, biopharmaceuticals constitute a major fraction in the bioprocessing industries, other components such as the fermentation sector manufacturing specialty products have markets amounting in multi-billions. The bioprocessing industries differ from the traditional chemical processing/refining industries in the sense that, these industries use microorganisms to convert substrates to required products. The bioreactions associated with these processes are kinetically and thermodynamically safer as compared to the conventional chemical reactions. However, due to their unique nature, these processes are plagued with various unforeseen hazards. This necessitates the need to review the existing research in the field of biotechnology and bioprocessing to minimize/eliminate these hazards and pave the path towards a safer bioprocessing industry.

The methodology involved in this study comprises of analyzing the different types of incident involved in the bioprocessing industries that include dust explosions, sub-standard production (i.e. production of contaminated products), biohazard/active product ingredient exposure, fire and explosion amongst others. This will be followed by a review of the conventional practices followed in chemical/refining industries and their applicability for bioprocessing industries will be analyzed. Lastly, recent developments in the field of biotechnology will be examined from the perspective of improving process safety. An example of this methodology can be observed in the University of Hawaii incident in 2016 involving the manufacture of biofuels in a conventional bioreactor. The process required the supply of oxygen as a nutrient to the bioreactor containing the bacterial culture. This incident involved an explosion resulting from a spark from a pressure gauge. The conventional design guidelines state that reactors should be inerted with nitrogen to decrease the concentration of oxygen below the limiting oxygen concentration to prevent the possibility of explosion. However, this may not be possible for the bioreactor under consideration, as sufficient level of oxygen is essential for the bioreaction to occur. Therefore, a safer design alternative will be to implement an anaerobic process (that does not require oxygen) to eliminate the hazard associated with the explosion. Therefore, as observed from this example, such line of thought can help in establishing guidelines towards designing inherently safer bioprocesses.