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New product launch | Alioth Alisafe® TCHF Gas Sterilization Filter, Guarding the Fermentation Process in Bioreactors

Bioreactors are core equipment in biopharmaceuticals for microbial/cell culture, and their sterile environment relies on efficient sterilizing filtration for both inlet and exhaust gases. For gas filtration, it is essential to select filters with appropriate materials (such as hydrophobic PTFE membranes) and pressure-resistant structures to ensure retention efficiency and system stability, thereby guaranteeing a zero-pollution risk in the fermentation process.

 

 

New Release

 

Alioth has launched a full range of brand-new Alisafe® TCHF sterilizing-grade filters, adopting PTFE membrane materials to further enrich its gas sterilization product portfolio. Driven by end-user applications, Alioth continues to deepen its exploration in the field of sterilizing filtration technology. The Alisafe® TCHF hydrophobic sterilizing-grade filters, made of polytetrafluoroethylene (PTFE), include cartridge filters and Alicap® L-type capsule filters. With stable performance and a diverse range of sizes, this product aims to meet the varied demands of different pharmaceutical processes for bioreactor gas filters, providing a solid guarantee for the safe production of pharmaceuticals.

 

Why choose the Alisafe® TCHF sterilizing-grade filter?

The Alioth Alisafe® TCHF series features a hydrophobic and chemically inert PTFE (polytetrafluoroethylene) filter membrane. This product efficiently retains microorganisms and particles in wet or humid gas through stringent liquid bacteria retention verification. It offers high strength and resistance to multiple steam sterilizations in place. The TCHF series is suitable for sterile gas filtration and organic
solvent filtration with strict quality requirements in pharmaceutical applications.

 

Typical Applications

  • Bioreactors (inlet | outlet)

  • Storage tank venting

  • Filling equipment venting

  • Freeze dryer

  • Autoclave venting

  • Sterile filtration of organic solvents

 

Product Advantages of Alisafe® TCHF

High flow rate, low pressure drop

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气体流量 ‐ Alisafe® TCHF 0.2μm 筒式滤芯

 

Multiple online or offline steam sterilizations

Steam in place at 142℃ for 30 min, 150 cycles (100 forward cycles plus 50 reverse cycles)
Autoclave at 135℃ for 30 min, 200 cycles
 

Strong pressure differential resistance

Forward: 7.0 bar（101.5 psi）@ 25°C/3.0 bar（43.5 psi）@ 80°C
Reverse: 4.0 bar ( 58.0 psi）@ 25℃/1.0 bar ( 14.5 psi）@ 80°C
 

Compliance regulations for the Alioth Alisafe® TCHF series hydrophobic PTFE filters:

• Bacterial Retention：Meets the ASTMF838 standard，>107 cfu/cm2 B.diminuta (  ATCC® 19146TM)

• Biological Safety：All construction components meet the biological safety requirements refering to USP<88>Class VI plastic

• Cleanliness：Meets the requirements for a ‘non-fiber releasing’ filter defined in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and particulate matter meets the requirements of USP<788>

• Endotoxin：Endotoxin﹤0.25 EU/mL by LAL test method, which complies with the requirements of USP<85>

• Indirect Food Additive：All component materials meet the requirements of Indirect Food Additive cited in EU 1935/2004/EC and FDA 21 CFR 177-182

• Animal-free Origin： All materials used in the manufacture of this filter are animal-free.

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