Scientific Publications by FDA Staff

J Ind Microbiol Biotechnol 2013 Apr;40(3-4):327-34

Evidence for grow-through penetration of 0.2-mum-pore-size filters by Serratia marcescens and Brevundimonas diminuta.

Kaushal S, Gervais B, Lute S, Eroraha A, Faustino P, Brorson K, Hussong D

We find that both Brevundimonas diminuta and Serratia marcescens can grow through sterilizing grade filter membranes of different membrane polymer compositions. Although this passage does not occur on a consistent basis, generation of "grow-through positive" results indicate that grow-through can occur stochastically at basal levels. This observation argues that the following risk mitigation strategies during pharmaceutical aseptic processing are warranted: minimization of processing times, and monitoring, minimizing and characterizing pre-filter bioburden.