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Mycoplasma Control Liquid Filtration in Biopharmaceutical Production

Enhanced sterilizing-grade filtration where mycoplasma control is paramount

Efficiently protect your bioreactor and cell cultures from microbial contamination

 

During cGMP biomanufacturing, inadvertent use of mycoplasma-contaminated growth medium or additives can be costly, leading to reduced productivity, lengthy investigations and lost manufacturing time.

 

The risk of growth media or bioreactor additions becoming contaminated by mycoplasma can be influenced by many factors, including the scale of production, choice of raw materials and water, operator processes, and preparation methods. 

 

For a large-scale production facility where growth media and bioreactor addition volumes in excess of 1000 L are prepared on site, the highest level of mycoplasma safety assurance can be achieved using sterilizing-grade filters with a 0.1 µm rating.

 

Sterilizing-grade filtration with mycoplasma control

 

0.1 µm-rated sterilizing-grade filters designed to remove mycoplasma will produce a sterile filtrate under the same challenge conditions with Brevundimonas diminuta (>107cfu/ cm2 effective filtration area) as a 0.2 µm sterilizing-grade filter.

 

In addition, the “tighter” 0.1 µm-rated membrane has enhanced removal efficiency for mycoplasma, >8 log reduction value (LRV) when challenged with mycoplasma such as Acholeplasma laidlawii, or Mycoplasma orale.

 

Efficient mycoplasma control filtration in high-fouling fluids

 

Pall has made advances in filtration design to ensure our Fluorodyne® 0.1 µm sterilizing-grade filters are adapted to perform efficiently with both low and high-fouling fluids.

 

  High fouling Low fouling
Growth Media  “Complex” “Defined”
Bioreactor Additions Animal and plant digests (peptones), serum.  Highly soluble, chemically synthesized/ processed amino acids and sugars.

 

Fluorodyne EX EDT Filters for high-fouling or complex media

 

Our 0.1 µm-rated Fluorodyne EX EDT Filters have an enhanced capacity for high-fouling biological fluids due to:

 

  • Laid-over pleat membrane geometry
  • Narrow core 10-inch module cartridge construction
  • Asymmetric membrane technology
  • High filtration area (0.95 m2 EFA per 10-inch module).

 

 

 

Fluorodyne II DJL Filters for low-fouling / “defined” media

 

Our 0.1 µm-rated Fluorodyne II DJL Filters have a high flux and capacity for low-fouling fluids due to:

 

  • Double layer symmetric membrane construction
  • Filter pack construction optimized for flow over capacity

 

Irrespective of fluid type, where mycoplasma safety is a priority, we recommend our high-performance Fluorodyne EX EDT Filters, with a proven LRV of >10 for Mycoplasma orale and Acholeplasma laidlawii.

 

Sterilizing-grade mycoplasma control filter selection guide

 

Filters are available in a wide range of devices, carts and capsules.

 

Family Fluorodyne II Fluorodyne EX
Grade DJL EDT
Removal rating 0.1 µm 0.1 µm
Mycoplasma removal efficiency > 8 LRV with Acholeplasma laidlawii >10 LRV with Acholeplasma laidlawii and Mycoplasma orale
Membrane Material PVDF PES/PVDF
Support, Drainage, Core Material Polypropylene Polypropylene
Membrane layers Double Triple
Pleat geometry, membrane asymmetry No Yes
Gamma-sterilizable Yes Yes
Steam and autoclave sterilizable Yes Yes
Compatibility Good Good
Transmission (preservatives/protein) Excellent transmission with low protein and excipient binding properties Excellent transmission with low protein and excipient binding properties
Wettable after steam dry Yes Yes
Growth media and nutrient feed applications High clean water flow rate in low-fouling feeds Efficient performance in medium – high-fouling feeds

 

Need help choosing the right filter?

 

Our Scientific and Laboratory Services (SLS) have been helping our customers to optimize their processes for more than 50 years.  Together with our wide range of filter membranes we can find the right filtration solution for your fluid or help to optimize your sterile filtration process.

Request a consultation with one of our sterile filtration specialists to discuss your process and offer free support to help you get it right.

Fluorodyne II DJL Filters

Ideal for high retention of mycoplasma and high flow rates in low-fouling fluids.
Ideal for high retention of mycoplasma and high flow rates in low-fouling fluids.
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Fluorodyne EX EDT Filters

High-performance mycoplasma retention, recommended where mycoplasma safety is a priority, and in high-fouling or complex fluids.
High-performance mycoplasma retention, recommended where mycoplasma safety is a priority, and in high-fouling or complex fluids.
Read more

Bioburden Reduction Liquid Filtration 0.45 µm or 0.2 µm Membranes

Efficient bioburden reduction in preparative applications
Efficient bioburden reduction in preparative applications
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Sterilizing-grade Liquid Filtration 0.2 µm Membranes

Sterilizing-grade filtration for aseptic processing and fill finish applications
Sterilizing-grade filtration for aseptic processing and fill finish applications
Read more