PureFlo® PES Filter Cartridges - Pharmaceutical Grade
ThePureFlo® pharmaceutical grade cartridges are designed to produce product sterility. The all-polypropylene construction provides excellent chemical compatibility and superior flow per surface area as compared to other membrane cartridges. PureFlo® pharmaceutical grades cartridges have been designed for final filtration in biopharmaceutical applications. The hydrophilic PES membrane does not require pre-wetting agents, thereby eliminating a potential source of contamination. The PES membrane has low protein-binding characteristics to maximize yields.
No adhesives, binders, or surfactants are used in the manufacturing process. All cartridges are rinsed with pyrogen-free water to reduce extractables and downtime. All filter cartridges are 100% integrity tested to ensure filter performance and quality. PureFlo® pharmaceutical grade filter cartridges are well-suited for critical applications where superior flow and bacterial retention is required.
SPECIFICATIONS
Regulatory Compliance Manufactured from materials that conform to the requirements of 21CFR Part 177 of the U.S. Code of Federal Regulations and USP Class VI Biological Test for Plastics. ISO 9001, ISO 14001 and ISO 13485 certified. Bacterial Retention Complete retention of > 107organisms/cm2 of Brevundimonas diminuta in accordance with the current HIMA challenge methodology (ASTM F838-83).Validation Guide upon request. Autoclavable & Sanitizable Filters can be autoclaved at 126°C for 60 minutes or chemically sanitized in situ using common sanitizing agents such as hot water at 90°C, or, up to five steam-in-place cycles at 135°C (275°F) at <0.35 bar (5 psid) for 20 minutes. Water Bubble Point Specification 0.1um: 23psi,0.16 MPa(IPA) 0.2um: 47psi,0.32 MPa Bio-Safety Filter effluent is non-pyrogenic per USP bacterial endotoxin (<0.25 EU/ml)
