Pharmsteri PES cartridge filters help ensure reliable product processing in pharmaceutical applications.
- Meets the requirements of WFI set by USP
- Meets the criteria for a non-fiber releasing filter defined in 21 CFR 210.3(b)(6)
- Tested according to USP<665>
- Meets the FDA Indirect Food Additive requirements cited in 21 CFR 177-182
- 20 cycles of steam-in-place (SIP) sterilization or autoclave, 30 min at 127 °C (261 °F)
Polypropylene components and polyethersulphone (PES) membrane construction allow use in a broad range of applications. Optimized form factor allows high flow and low pressure drop, lowering cost of ownership.
Effective filtration area: Single-layer - 0,6 m²/254 mm cartridge, Dual-layer - 0,53 m²/254 mm cartridge
Endotoxin releasing: <0,25 EU/ml as determined by the LAL test
Conductivity: ≤1,3 µS/cm after water flush of 11 L/254 mm cartridge
Applications includes Bioburden reduction of LVP/SVP, sterile filtration for LVP/SVP/API, Buffers, culture medium, intermediates.
Certifications: All components meet USP <88> Class VI Plastics Test and USP<87> Biological Reactivity Test, providing biocompatibility insurance and global regulatory compliance.