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

Abstract

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.

Bacterial Retention During Filtration of a Live Attenuated Virus Vaccine Through the Sartobran P Sterile Filter

“…There is also some evidence that bacteria can grow in the filter matrix, with smaller daughter cells eventually migrating all the way through the sterile filter. 6,13 There are a number of unique challenges in applying sterile filtration for the production of vaccines and virus-like particles. First, many vaccines are similar in size to the 0.2 µm-rated pores of sterilizing grade filters, leading to substantial yield loss and high levels of membrane fouling.…”