Ensure Integrity And Prevent Contamination In Single-Use Bags

By Trisha Gladd, editor, Bioprocess Online

As single-use systems continue to gain in popularity, so does the use of single-use bags. A single contract manufacturer can use thousands of bags per year. Gallus Biopharmaceuticals has used over 40,000 bags in just the past decade. Due to the volume increases in some of these bags, the prevention of possible contamination issues has never been more important. More pharma manufacturers are now looking to perform point-of-use tests to ensure the integrity of the bags they are using.

Ensuring bags are free from defects can save a company from having to deal with unhappy clients, production shutdowns, wasted hours, FDA 483s and warning letters, and of course the loss of valuable product from contamination. One way a pharma manufacturer can avoid contamination issues immediately prior to use is to perform a final integrity test. Pressure decay testing is one method of doing so.