Every year, the global pharmaceutical industry produces trillions of doses of medications. Manufacturing these drugs involves several stages, and the chance of contamination increases with every step.

Thus, before a single drop of any drug can be given to a patient, it must be sterilized. In my work as a researcher in pharmaceutical manufacturing, I investigate how the properties of different drugs and filters affect how well medications are sterilized through certain methods. Ensuring drug safety while maintaining product integrity remains a persistent and technically nuanced challenge, even on a good day.

As medical therapies become increasingly complex, however, the goal to keep these drugs safe from bacterial contamination is facing unprecedented bottlenecks, including global drug shortages due to fragile materials, regulatory pressures and strained supply chains.

From contamination to crisis

Sterile filtration acts as a shield between a manufactured drug and a patient. When this shield fails, contamination is costly for both patients and manufacturers.

In 2012, a large-scale fungal meningitis epidemic broke at the New England Compounding Center. Epidural injections were contaminated at the pharmacy with the fungus Exserohilum rostratum due to inadequate sterilization and poor aseptic conditions during manufacturing. This oversight caused over 750 infections and more than 60 deaths.

In 2021, the contamination of one manufacturer’s multiuse gel for ultrasounds led to outbreaks of Burkholderia stabilis bacterial infections across 10 American states. Around 14 deaths were linked to the manufacturer’s inappropriate testing of the finished product, inadequate inspection of raw materials and lack of environmental........

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