This article has been reviewed according to Science X's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility: Manufacturing modern medicines is a multistage process, and each step introduces the opportunity for contamination, which can be both deadly and expensive. Recently, epinephrine injections, used for severe allergic reactions, were recalled due to a lack of assurance of sterility, according to the U.S.
Food and Drug Administration. Penn State chemical engineering doctoral candidate Shreya Kapila is working to improve the sterilization process by surface-modifying the membranes used in sterile filtration of pharmaceutical products to remove bioburden. She conducts research in the laboratory of Andrew Zydney, Bayard D.
Kunkle Chair and professor of chemical engineering at Penn State. The research is published in the Biotechnology Journal. In this Q&A, Kapila discusses the importance of drug sterilization, the findings of her research related to sterilizing drugs and the opportunities she has had to contribute to pharmaceutical safety as a graduate student at Penn State.
Kapila: Pharmaceutical products can become contaminated with microorganisms such as bacteria and fungi, particulate matter and other impurities introduced during different steps involved in manufacturing. For injectable drug products, maintaining sterility is especially important because the product is administered directly into the patient's body, where microbial contamination can have serious consequences. Drug manufacturers use multiple layers of control to prevent contamination and maintain product quality.
These include controlled manufacturing environments, sterilized equipment, validated cleaning procedures and processes designed to prevent or remove microorganisms. At the same time, manufacturers ensure that processing does not adversely affect the product. The goal is therefore not only to achieve sterility, but also to maintain the chemical, physical and functional properties—including purity, potency, physical stability and particle or droplet size—of the pharmaceutical product.
Kapila: Time and cost can vary greatly; some sterilization processes can be completed relatively quickly, while others require extended processing, preparation and validation. Sterilization can become particularly challenging when the drug product is sensitive to heat or other processing conditions. Manufacturers may need specialized equipment, additional processing steps or more complex aseptic processing.
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