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Evaluating Performance of 0.1mic Filter

This document evaluates the performance of 0.1 μm rated filters for mammalian cell culture media filtration. It finds that Pall Corporation's Fluorodyne EX EDT filter demonstrates significantly higher filtration capacity (up to 9 times) and superior mycoplasma retention compared to other 0.1 μm rated filters. The higher capacity and larger surface area of the Fluorodyne EX EDT filter allows processing of media batches with fewer filter cartridges.

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Abhijit Ghosh
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150 views1 page

Evaluating Performance of 0.1mic Filter

This document evaluates the performance of 0.1 μm rated filters for mammalian cell culture media filtration. It finds that Pall Corporation's Fluorodyne EX EDT filter demonstrates significantly higher filtration capacity (up to 9 times) and superior mycoplasma retention compared to other 0.1 μm rated filters. The higher capacity and larger surface area of the Fluorodyne EX EDT filter allows processing of media batches with fewer filter cartridges.

Uploaded by

Abhijit Ghosh
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Advertorial Pall Corporation

Evaluating the Performance of 0.1 µm Rated Filters for


Mammalian Cell Culture Media Filtration

T
he performance of 0.1 μm rated filters is evaluated for evaluated to compare relative throughputs. Three different culture
cell culture media filtration applications requiring high media solutions: (a) 30 g/L Tryptic Soy Broth, (b) 13.4 g/L Dulbecco’s
mycoplasma retention and high filtration capacity. Modified Eagle’s Medium (DMEM) supplemented with 7.5 g/L
proteose peptone #3 (PP3) and (c) 10% bovine serum were filtered
INTRODUCTION through discs of each filter type. The filtration was conducted under
Recent market trends in mammalian cell culture involve larger- a constant differential pressure of 690 mbar (10 psid) and the filter
scale production facilities and increased cell titers. Both trends capacity, based on membrane area, was calculated.
contribute to an increased value of the fermentation batches and
increased costs of contamination events. The increasing size of RESULTS
fermenters calls for filtration of larger volumes of culture media, Capacity ratios relative to Fluorodyne EX EDT filter membranes
creating a need for filters with higher capacity. At the same are presented in Figure 1A. With all three culture media, the
time, mycoplasma retention by culture media filters becomes Fluorodyne EX EDT filter membranes demonstrated greater
even more critical, as penetration of 0.2, 0.22 and even some capacity (up to nine-fold greater) than the other 0.1 μm rated filters.
0.1 μm filters has been well documented.1 In this application The higher capacity of the EDT filter membranes, coupled with
note, we describe how a new filter cartridge development can larger membrane area in a 254 mm (10 in.) filter element achieved
help optimize filtration costs and maximize the safety of both through the small-core Ultipleat design (0.95 m2 for Fluorodyne
mammalian cell fermentations and and aseptic fill validations. EX EDT compared to 0.49–0.6 m2 for other 0.1 μm filter cartidges),
The new Pall Fluorodyne EX grade EDT filter is a hybrid allows for fewer cartridges to process a 5,000 L batch (Figure 1B).
polyethersulfone/poly v inylidine f luor ide (PE S/PV DF)
0.1 μm sterilizing grade filter designed for high throughput CONCLUSIONS
applications where control of mycoplasma is a key concern, such With higher filter capacity and superior mycoplasma retention
as in mammalian cell culture media preparation and aseptic levels (>10 LRV versus >6–7 LRV claimed for the other 0.1 μm
filling validations. The new filter incorporates Pall’s MachV filters tested), Pall Fluorodyne EX EDT filter technology offers
asymmetric membrane technology for maximized capacity, an improved level of performance and safety for critical
Ultipleat membrane folding for enhanced surface area, and biomanufacturing media filtration applications. The new
narrow core architecture for increased pleat pack stability and development allows a smaller sizing of existing filtration
filtration speed. The 0.1 μm PVDF sterilizing layers assure systems, typically not requiring a prefiltration step, and is
retention of Brevundimonas diminuta (ATCC 19146) at well-supported by a comprehensive validation package.
>107 cfu/cm² and a >10 log reduction value (LRV) for Acholeplasma
laidlawii (ATCC 23206) and Mycoplasma orale (ATCC 23714). REFERENCES
1. Potts B, editor. Proceedings from the PDA Workshop on
EXPERIMENTAL CONDITIONS Mycoplasma Contamination by Plant Peptones; 2005 Sep.
Three 0.1 μm rated filters with mycoplasma removal claims were Bethesda, MD: PDA, 2007.

Figure 1. (A) Capacity ratios (based on membrane area) relative to Pall Flurodyne EX EDT. (B) Number of 254 mm (10 in.) cartridges
relative to the number of 254 mm (10 in.) Pall Fluorodyne EX EDT cartridges necessary to filter a 5,000 L batch assuming linear scale-up.
A B

2 BioPharm International www.biopharminternational.com April 2009

bp0409_PallAppNote.incx 2 3/13/09 4:45:40 PM

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