Scale-up of sterilizing-grade membrane filters from discs to pleated cartridges: effects of operating parameters and solution properties

A Kumar, J Martin, R Kuriyel - PDA journal of pharmaceutical …, 2015 - journal.pda.org
For direct flow sterilizing-grade filtration, a linear scale-up between the performance of discs
and pleated filter cartridges has traditionally been assumed. Linear scale-up assumes that …

Scaling from discs to pleated devices

S Giglia, D Yavorsky - PDA Journal of Pharmaceutical Science and …, 2007 - journal.pda.org
Membrane discs offer a convenient format for evaluating membrane performance in normal
flow filtration. However, while pleated devices of different sizes tend to scale in close …

Sterilizing filtration—principles and practice for successful scale-up to manufacturing

P Rajniak, SC Tsinontides, D Pham, WA Hunke… - Journal of Membrane …, 2008 - Elsevier
Filtration process design using micro-filtration membranes includes the proper sizing and
scale-up of filtration units and requires an understanding of the effects of membrane fouling …

Scalability of sterilizing-grade filters in different filtration modes

D Jannik, H Sebastian, H BjÖrn… - PDA journal of …, 2020 - journal.pda.org
Scalability of filter throughput in normal flow filtration runs is an important consideration in
the development of biopharmaceutical downstream processes. Depending on the filtration …

Scale‐down prediction of industrial scale pleated membrane cartridge performance

AI Brown, NJ Titchener‐Hooker… - Biotechnology and …, 2011 - Wiley Online Library
Flat‐sheet membrane discs represent the current standard format used for experimental
prediction of the scale‐up of normal flow filtration processes. Use of this format is …

Retention characteristics of sterile filters–effect of pore size and structure

N Taylor, WJ Ma, A Kristopeit, S Wang… - Journal of Membrane …, 2021 - Elsevier
Sterile filtration is used to remove microorganisms in the processing of most recombinant
proteins, but there are significant challenges in applying this technology to large …

[PDF][PDF] Sterile filtration--a review of the past and present technologies

MW Jornitz, PG Soelkner… - PDA Journal of …, 2002 - researchgate.net
Sterilizing grade membrane filters are widely used for the intermediate and final filtration of
liquid drug products. Their function is either to reduce the bioburden level within the liquid …

Studies on the scale-up of microfiltration membrane devices

DJ Brose, S Cates, FA Hutchison - PDA Journal of Pharmaceutical …, 1994 - journal.pda.org
This paper addresses the prediction and modeling of fouling in microfiltration (MF)
membrane devices during the filtration of biological solutions. The membrane-fouling model …

[PDF][PDF] Quantifying sterilizing membrane retention performance

MM Blanchard - BioProcess International, 2007 - eu-assets.contentstack.com
In aseptic processing, performance of sterilizing filtration is of critical importance. A filter
device must provide high confidence of retaining organisms under production conditions as …

Critical influences of particles, pores, and prefilters in sterilizing filtration

RE Madsen, TH Meltzer - PDA Journal of Pharmaceutical Science …, 2009 - journal.pda.org
Sterilizing filtration process variables can cause unpredictable results and post-filtration
integrity test values that are not representative of those obtained during validation of the …