Description
Applications Monoclonal antibodies (mAbs) Vaccines Plasma, cell and gene therapies Other process steps for liquid buffer/media, semi-product filtration or final product filtration Available with different sterilizing-grade filter media and filter sizes and a choice of different connection types and tube materials. All standard filter sets are supplied gamma irradiated and supported with a comprehensive documentation package. Filter set components Two sterilizing-grade filter medias are available in standard filter sets – Supor™ EKV filters and Fluorodyne™ II DFL filters. Supor™ EKV filters include a 0.2 micron-rated validated sterilizing-grade filter membrane. The incorporated polyethersulfone (PES) membrane demonstrates high compatibility over the whole pH range plus low protein binding to optimize transmission of the active ingredients (see data file Supor™ EKV filters). Fluorodyne™ II DFL filters also feature a 0.2 micron-rated validated sterilizing-grade filter membrane. The incorporated polyvinylidene fluoride (PVDF) membrane ensures low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions (see data file Fluorodyne™ II filters). The Kleenpak™ capsules are rugged and compact filter capsules available with a broad range of filter media and different sized formats designed for a variety of small to large scale pharmaceutical manufacturing applications with volumes of 2 to 1000 L. The Kleenpak™ Presto sterile connectors are integrated into standard filters sets. The Kleenpak™ Presto sterile connector is quality assured and inspected at point of manufacture to allow device traceability, as each device has its own serial number. The manufacturing process of Kleenpak™ Presto sterile connectors uses an automatic vision system that limits defects in the membrane and membrane welding (see data sheet Kleenpak™ Presto sterile connectors). A summary of available Allegro™ Ready filter sets configurations and detailed design information are shown in the datafile found in our document section.
