This message was posted by a user wishing to remain anonymous
Minimize Contamination in Pharmaceutical Products
Join AAPS on Thursday, September 5, 12:30pm-2:00pm ET for:
This presentation highlights the importance of reducing particulate contamination in pharmaceutical and biopharmaceutical products manufactured using single-use systems (SUS). Contamination is classified into visible and subvisible particles, with subvisible particles more effectively detected using automated methods.
Mark Bumiller of Entegris, Inc., introduces a testing method for minimizing subvisible particulate contamination. The data from his method shows that submicron particles below specified limits provide valuable insights into the cleanliness of the products.
Additionally, for cell and gene therapy products that cannot use a final sterilizing-grade filter, he recommends selecting a SUS with cleanliness levels that exceed regulatory standards. This helps ensure the safety, potency, and quality of drug products.
All AAPS members receive immediate and free access to numerous archived AAPS webinars similar to the ones above along with many other high-value benefits.