title: 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.
authors: Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, USA.
authors: Simran
authors: S
authors: Kaushal
authors: Brandi
authors: B
authors: Gervais
authors: Scott
authors: S
authors: Lute
authors: Ajiri
authors: A
authors: Eroraha
authors: Patrick
authors: P
authors: Faustino
authors: Kurt
authors: K
authors: Brorson
authors: David
authors: D
authors: Hussong
mesh_terms: D042063:Caulobacteraceae / Q000254:growth & development*; D005374:Filtration / Q000295:instrumentation*; D012706:Serratia marcescens / Q000254:growth & development*; D013242:Sterilization / Q000295:instrumentation*
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