Q&A: The safety and sterilization of pharmaceuticals manufacturing
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.
The process of manufacturing modern medicines involves multiple stages, each introducing potential contamination risks that can be deadly and costly. Recently, epinephrine injections for severe allergic reactions were recalled due to concerns about sterility, according to the U.S. Food and Drug Administration.
Shreya Kapila, a Penn State chemical engineering doctoral candidate, is working to enhance the sterilization process by modifying the membranes used in sterile filtration of pharmaceutical products. This research, conducted in the laboratory of Andrew Zydney, a professor of chemical engineering at Penn State, has been published in the Biotechnology Journal.
Kapila emphasizes the importance of drug sterilization, particularly for injectable drug products that are administered directly into the patient's body. Maintaining sterility is crucial to prevent microbial contamination, which can have serious consequences. Pharmaceutical manufacturers employ multiple control measures, such as controlled manufacturing environments, sterilized equipment, validated cleaning procedures, and processes designed to prevent or remove microorganisms.
While ensuring sterility is essential, manufacturers also aim to maintain the chemical, physical, and functional properties of the pharmaceutical product, including purity, potency, physical stability, and particle or droplet size. The choice of sterilization method depends on the product's formulation, packaging, and stability.
Traditional methods include heat sterilization and gamma irradiation, while aseptic processing is another approach that requires extensive facility validation, specialized equipment, and strict personnel procedures.
Sterile filtration, widely used for vaccines and injectable liquid formulations with sensitive active pharmaceutical ingredients, is a common method. In this process, the drug product passes through a sterilizing-grade membrane designed to retain microorganisms while allowing the pharmaceutical product to pass through. Kapila's research focuses on improving sterile filtration processes by developing a fundamental understanding of factors governing nanoemulsion filtration through sterilizing-grade filters.
Prewetting membrane surfaces to increase surface hydrophilicity has shown promising results, reducing pore blockage, improving nanoemulsion flow through the membrane, and substantially increasing filter capacity. These findings demonstrate that relatively simple surface modification strategies can enhance filtration efficiency and product yield, offering both safety and economic benefits.
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