Lilly Official Offers Tips On Reducing Contamination Risks In Cleanrooms

07 Oct 2017

• By Joanne S. Eglovitch

Having a multilayered approach to sterility assurance is key to preventing contamination in cleanrooms, with equal attention paid to gowning, aseptic technique, engineering technique and proactive and detailed trending, says Eli Lilly official. Official also advises manufacturers to follow both USP Chapter 1116 and the EU’s Annex 1 if they want their sterility assurance programs to pass muster with inspectors and do business globally.

Sterility assurance programs must be complex and multilayered if they are to reduce contamination risks in cleanrooms. They also must take "strict" approaches that follow both EU Annex 1 and USP Chapter 1116 guidelines if they are to pass muster with inspectors for global distribution.

This was the advice imparted by Marcia Baroni, director of QC microbiology and environmental monitoring and sterility assurance for Eli...