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|Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Polysep II|
Polysep™ II filters are ideal for a broad range of aqueous-based applications. The Polysep II media consists of a borosilicate glass layer and a layer of mixed esters of cellulose membrane. The depth of the microfiber filter layer provides high particle loading capacity, and retention of large particulates while maintaining high flow rates. The mixed cellulose ester membrane layer provides the high retention needed during critical prefiltration steps while protecting more expensive downstream filtration devices and equipment.
Polysep II cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Polysep II cartridge filters are integrity tested during the manufacturing process.
Polysep II filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
A full range of filtration areas is available to suit varying application requirements. A variety of connection options are offered for easy adaptation to existing housings.
Reduce particulate contamination and bioburden before final sterilizing filtration and provide excellent protection for sterilizing grade membrane filters in applications requiring more extensive buffer prefiltration.
Cell Culture Media
Polysep II prefilters effectively remove particles including lipids, and colloidal contaminants without obstructing the flow of vital media constituents.
Large Volume Parenterals (LVP)
Extend the service life of downstream sterilizing filters by removing colloidal and partiulate contaminants. The robust design withstands high differential and operating pressures, high flow rates and multiple steam-in-place or hot water sanitization cycles.
Polysep II prefilters reduce particle and bioburden before sterilizing filtration and will withstand process variability.
Polysep II prefilters remove lipids, colloids, and particles from serum before final sterilizing filtration without obstructing the passage of serum proteins.
|Per 10-inch Cartridge|
|Double Layer||0.46 m²|
|Materials of Construction|
|Filter media||Mixed Cellulose Esters (MCE)|
|Prefilter media||Borosilicate Glass Fiber (BGF)|
|Supports||Spun bonded polypropylene|
|Maximum Differential Pressure, bar (psid)||3.5 bar (50 psid) @ 25 °C|
|Gravimetric Extractables||The extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.|
|Oxidizable Substances||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Sterilization||10 autoclave cycles or SIP @ 121 °C for 30 min|
|Sanitization||30 min with hot water @ 80 °C|
|Component Material Toxicity||Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|