Potential Remediation Measures That May Be Taken on Detection of a Suspect Bioburden Event
| • Apply a corrective sanitization using a more robust sanitization solution. MabSelect SuRe: 0.1–0.5 M NaOH; Prosep Ultra: 3% benzylalcohol (with 0.3% HCl). Acidification of the benzyl alcohol significantly improves the microbial kill kinetics, enabling effective sanitization. |
| • Some companies perform proactive sanitization with a stronger solution following high-impact activities (e.g., after packing and prior to each batch). |
| • Repeated sanitizations (e.g., three consecutive) may be more effective than a stronger solution in some cases. |
| • Physical removal may be more important to remove sporeformers (higher caustic levels may not be effective in in isolation). |
| • Increase the flush volume and sanitize in up- and down-flow mode. |
| • Empty columns can be passivated in response to detection of biofilm. |
| • Preventative maintenance procedures and soft part inspection frequency is enhanced. |
| • Manual cleaning of valves may be performed in difficult-to-clean locations. |
| • Separate sampling of gradient cart and column rinse water generally demonstrates the contamination location at column level. |