Addressing The Options And Challenges In Subvisible Particulate Contamination Monitoring In Single Use Systems

This presentation emphasizes the significance of minimizing particulate contamination in pharmaceutical and biopharmaceutical products produced through the use of single-use systems (SUS). The contamination can be categorized into visible and subvisible particles, with the latter being more readily detectable through automated techniques. Mark Bumiller, Technology Manager, Entegris, Inc., outlines a method for testing subvisible particulate contamination, and the obtained results demonstrate that data on submicron particles below specified limits offer valuable insights into the cleanliness levels of the products. For cell and gene therapy products that cannot employ a final sterilizing grade filter, it is advisable to select SUS with cleanliness levels that surpass regulatory requirements to guarantee the safety, potency, and quality of the therapeutics.