Integrity test measurements - The effects of bacterial cell loading

A. Mark Trotter, Theodore H. Meltzer, Fang Bai, Laura Thoma

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

This article examines the effects of particulate loading on filter integrity test measurements using a suspension of Brevundimonas diminuta as the contaminant. The authors investigated the influences of both low and high bacterial loadings on bubble-point, single-point diffusive airflow (forward- flow), and multipoint diffusive airflow tests. Integrity testing is used critically at the end of an aseptic filtration process to determine the filter's functional integrity and, therefore, the sterility of the filtered fluid. Bacterial loading, particularly at higher levels, plugged the pores sufficiently with a concomitant decrease in porosity, which significantly reduced diffusive airflows and elevated the bubble points. The relationship between bacterial loading and diffusive airflows, particularly when derived from multipoint tests, suggests hypothetical conclusions regarding membrane pore structures that may be of interest in the filtration validation exercise.

Original languageEnglish (US)
Pages (from-to)72-80
Number of pages9
JournalPharmaceutical Technology
Volume24
Issue number3
StatePublished - Mar 1 2000

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Porosity
Infertility
Suspensions
Membranes

All Science Journal Classification (ASJC) codes

  • Biophysics
  • Pharmaceutical Science

Cite this

Trotter, A. M., Meltzer, T. H., Bai, F., & Thoma, L. (2000). Integrity test measurements - The effects of bacterial cell loading. Pharmaceutical Technology, 24(3), 72-80.

Integrity test measurements - The effects of bacterial cell loading. / Trotter, A. Mark; Meltzer, Theodore H.; Bai, Fang; Thoma, Laura.

In: Pharmaceutical Technology, Vol. 24, No. 3, 01.03.2000, p. 72-80.

Research output: Contribution to journalArticle

Trotter, AM, Meltzer, TH, Bai, F & Thoma, L 2000, 'Integrity test measurements - The effects of bacterial cell loading', Pharmaceutical Technology, vol. 24, no. 3, pp. 72-80.
Trotter AM, Meltzer TH, Bai F, Thoma L. Integrity test measurements - The effects of bacterial cell loading. Pharmaceutical Technology. 2000 Mar 1;24(3):72-80.
Trotter, A. Mark ; Meltzer, Theodore H. ; Bai, Fang ; Thoma, Laura. / Integrity test measurements - The effects of bacterial cell loading. In: Pharmaceutical Technology. 2000 ; Vol. 24, No. 3. pp. 72-80.
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