zh-cn
  • sns01-1
  • sns04-1
  • sns02-1
Leave Your Message

Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges - China Suppliers & Factory with Double-Layer Design

Introducing our innovative double-layer filtration solution, designed to meet the highest standards of performance and reliability. Manufactured in China, our product features a unique construction that ensures exceptional bacterial and particulate retention, making it ideal for a variety of applications. With broad chemical compatibility across a pH range of 1 to 14, it easily integrates into diverse environments. Additionally, our filtration solution is engineered with extremely low extractables, guaranteeing purity and safety in sensitive processes. As a trusted supplier and factory, we are committed to delivering high-quality filtration solutions to meet your needs. Choose our double-layer design for effective and reliable filtration!

    Typical Applications
    Filtration of cell culture media
    Intermediate product and drug substance filtration
    Filtration of serum and blood products
    Final product filtration
    Product Specifications
    Working Conditions Standard Operating Limits
    Max. Temp 80°C
    Max. DP 0.55 MPa @ 25°C
    0.1 MPa @ 80°C
    Biological Safety
    Endotoxin < 0.25 EU/mL
    Biocompatibility Complies with USP <87>, No potential cytotoxicity.
    Complies with USP <88> Class VI Biological Reactivity requirements for plastics.
    Integrity Test Bubble Point and Diffusion Flow
    Sterilization Methods
    ChallengePore® PES Capsule Filters
    Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
    ChallengePore® PES Cartridge Filters
    Autoclave (up to 130°C, 30 min, 25 cycles) and Steam-in-Place (SIP).
    Frequently Asked Questions
    1. What are the typical applications for ChallengePore® PES Filters?
    ChallengePore® PES filters are designed for critical filtration processes, including cell culture media, intermediate product and drug substance filtration, serum and blood products, and final product sterilization.
    2. What are the maximum operating pressure and temperature limits?
    The maximum operating temperature is 80°C. The maximum operating differential pressure (DP) is 0.55 MPa at 25°C and 0.1 MPa at 80°C.
    3. How is the biological safety of these PES filters verified?
    They are certified safe with endotoxin levels under 0.25 EU/mL. They fully comply with USP <87> for cytotoxicity testing and meet USP <88> Class VI Biological Reactivity requirements for plastics.
    4. How can I sterilize ChallengePore® PES Capsule Filters?
    PES Capsule Filters can be sterilized using an autoclave at 121°C for 30 minutes (up to 5 cycles) or through Gamma Irradiation within the range of 25-40 kGy.
    5. Can ChallengePore® PES Cartridge Filters withstand Steam-in-Place (SIP)?
    Yes, the cartridge filters are designed to withstand Steam-in-Place (SIP) thermal cycles, as well as autoclaving up to 130°C for 30 minutes for up to 25 cycles.
    6. What integrity tests are recommended for these filters?
    To ensure reliable filtration performance and membrane integrity, both Bubble Point and Diffusion Flow tests can be performed.