High performance encapsulated pharmaceutical grade PES membrane filter
The PureFlo® PES filter capsule in its all-polypropylene construction provides excellent chemical compatibility and superior flow per surface area as compared to other membrane capsules. PureFlo® PES Filter Capsules have been specially designed for sterilizing in biopharmaceutical applications. Its hydrophilic PES membrane does not require pre-wetting agents, thereby eliminating a potential source of contamination. The PES membrane is low protein-binding.
The capsules were designed for simple and efficient filtration of small volumes used in low-flow application, laboratory, and pilot runs. No adhesives, binders, or surfactants are used in the manufacturing process of theses capsules. They are rinsed with pyrogen-free water to reduce extractables and downtime. All filter capsules are 100% integrity tested to ensure filter performance each and every time out of the package. PureFlo® PES filter capsules are well-suited for pharmaceutical applications where superior flow and bacterial retention is required. The capsule can be ordered pre-sterilized.
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 > 107 organisms/cm2 of Brevundimonas diminuta in accordance with the current HIMA challenge methodology (ASTM F838-83). Validation Guide available upon request.
Water Bubble Point Specification 0.1um: 23psi,0.16 MPA (IPA) 0.2um: 47psi,0.32 MPa AutoClavable and Sanitizable Capsules can be autoclaved up to 25 times at 125°C for 30 minutes or chemically sanitized in situ using common sanitizing agents such as hot water at 90°C for a limited time (dependent on time and temperature).
Bacterial Endotoxin Effluent is non-pyrogenic per USP Bacterial Endotoxin (0.25 EU/ml), determined using Limulus Amebocyte Lysate (LAL) Test.
Operating Conditions Maximum Forward Differential Pressure: 73 psid (5.0 bar) at 20°C 36 psid (2.5 bar) at 50°C 17 psid (1.2 bar) at 80°C Maximum Reverse Differential Pressure: 44 psid (3.0 bar) at 20°C Maximum Operating Temperature: 80° C
Materials of Construction Membrane: Hydrophilic Polyethersulfone Membrane Supports: Polypropylene, or PET option Cage, Core, End Caps: Polypropylene, or Polyethylene option Fitting Connections NPT, Sanitary Flange, Hose Barb, Coupling Vent/Drain: Luer Lock with Cap
Dimensions (TC Fittings) Length: 1.5 in (128 mm) Length: 2.5 in (155 mm) Length: 5.0 in (210 mm) Length: 10 in (340 mm) Diameter: 2.75 in (70 mm)
Effective Filtration Area 1.5 in - 0.77 ft2 (720 cm2) 2.5 in - 1.48 ft2 (1380 cm2) 5.0 in - 2.8 ft2 (2600 cm2) 10 in - 5.6 ft2 (5200 cm2)
