Although bioprocessing often focuses on cells, everything must stay clean—not just ordinary clean but sterilized. To explore the scope of this challenge, GEN talked with Alice Redmond, chief strategy officer at CAI, which recently partnered with Fedegari Group to provide high-performance sterilization systems.

“The sterilization challenge for bioprocessors primarily revolves around ensuring that all bioprocessing equipment and products are free from any microbial contamination and endotoxins,” says Redmond. “This is crucial because even a small level of contamination can compromise the safety and efficacy of the bioproducts, such as pharmaceuticals, and can lead to serious health risks for patients.”

According to Redmond, bioprocessors face three key challenges in sterilization. First, she says, “Manufacturers need to consider sterilization during the design process of bioprocessing equipment to facilitate easier and more effective cleaning and sterilization.”

Risk assessment

Next, risk assessment must be considered. Here, she notes that revisions to the EU’s Annex 1 and ICHQ9 R1 “highlight the issues that pharma needs to address.” In addition, human error must be avoided. “The manufacture of aseptic products requires human intervention and good aseptic practices,” Redmond points out. “Many of the warning letters issued by the FDA site poor aseptic practices and understanding as the root cause of sterilization issues.”

Although Redmond states that “achieving complete sterilization of complex equipment and operational procedures is difficult,” various methods can reduce this challenge. For one thing, some advanced materials are microbe-resistant. Using these materials in bioprocessing equipment reduces the risk of contamination.

Where possible, equipment can be designed to include fewer hard-to-clean areas. Human error can be reduced with automated systems for cleaning and sterilization. Those processes should also be monitored continuously. “Using sensors and IoT technology to monitor the sterilization process in real-time can ensure that the required conditions are met throughout the process,” Redmond says.

Like the rest of bioprocessing, sterilization procedures keep improving. As Redmond notes, “sterilization methods are continually being refined to enhance their effectiveness, reduce processing time, and ensure that they are safe for both the products and the environment.”

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