Why is sterility critical in bioprocessing and how is it maintained?

Sterility prevents contamination by unwanted microorganisms that could outcompete production organisms, consume nutrients, produce toxins, or degrade products. Sterility is maintained through: sterilization of media and equipment (autoclaving at 121C, 15-20 minutes), HEPA-filtered air supply, sterile technique during operations, positive pressure in clean areas, sterilizable connections and valves, and regular integrity testing of filters and seals. Sterility is validated using biological indicators and sterility testing. Contamination causes batch loss, product quality issues, and potential safety concerns. Good Manufacturing Practice (GMP) facilities have extensive contamination control programs.