For sterilizing products with high particle loads, HPPC filters offer a wide selection of validated, dual-layer, positively charged Polyethersulfone (PES) cartridges and capsule filters. Available in 0.03, 0.10, 0.22, and 0.45 μm, HPPC filters are validated for absolute bacteria retention to provide reliable sterile filtration performance. The positive charge removes negatively charged biological contaminants such as endotoxins, viruses, and other cell fragments. Depending on the level of contaminant and flow rate, HPPC filters will typically exhibit > 3-log removal of endotoxin.
Designed with a High Capacity PES prefilter layer and an asymmetric PES final filter layer, HPPC filters deliver high flow across a wide pH range. The HPPC filter’s low binding characteristics make it ideal for filtering products with preservatives and proteins that can adsorb to media. They are flushed to remove manufacturing debris and reduce extractables. Products are 100% integrity tested.
This combination of functionality makes the HPPC filter an excellent choice for pharmaceutical and biopharmaceutical applications.
HPPC filters are 100% integrity tested. They are developed and manufactured under an ISO 9001:2015 certified Quality Management System and designed to be used in cGMP-compliant processes.
HPPC filters are validated using test procedures that comply with ASTM F 838-15(ae1) protocols for the determination of bacterial retention in filters used for liquid filtration. The challenge level is a minimum of 107 organisms per cm2 of filter media. CPF filters have > 7-log removal when challenged with the organisms listed below (0.03μm, 0.10μm and 0.22μm meet the FDA definition of sterilizing grade filters). Validation Guides are available upon request.
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