Read full study>>Sodium hydroxide (NaOH) cleaning-in-place is the widely accepted method of sanitization employed by biopharmaceutical manufacturers to avoid the excessive costs and delays of a bioburden event in their downstream bioprocess.
Here, we describe a microbial challenge test with a concentration of 1-M NaOH to mimic typical sanitization practices employed by the biopharma industry for a broad range of resins. The final version of our method with resin and chemically dependent hold times is highly efficient as an integral part of the packing procedure.