• Buffers and Media Filtration
• Blood Serum Filtration
• Large Volume Parenteral (LVPs)
• Vaccines and Biologics
• Fermentation Broth Clarification
• Final Sterilizing Filtration
• Scale-Up and Clinical Batches
• Antibiotics and Protein-Based Pharmaceuticals

• Micron Ratings:
Triple Layer 5.0 μm PP/ 0.65 μm PP/ 0.2 μm PES

• Effective Filtration Area:
1. 10-Inch: 0.7 m²
2. 20-Inch: 1.4 m²
3. 30-Inch: 2.1 m²

• Materials of Construction:
1. Filter Media: PES - Biological Grade (Hydrophilic, Low Protein Binding, High
Flow Rate)
2. Supports, Core, Cage, End Caps: Polypropylene
3. O-Rings: Silicone (Standard), EPDM, Viton, or Teflon-encapsulated options
4. Sealing: Thermally bonded, adhesive-free

• Operating Conditions:
1. Max Forward Differential Pressure: 5.5 bar (80 psi) at 25°C
2. Max Operating Temp: 80°C (176°F) at 0.7 bar
3. Min Burst Pressure: 8.3 bar (120 psi)
4. Max Reverse Pressure: 3.0 bar (44 psi)

• Bacterial Retention:
1. 0.1 µm: LRV ≥ 8 (B. diminuta)
2. 0.2 µm: LRV ≥ 7 (B. diminuta)
3. 0.45 µm: LRV ≥ 7 (S. marcescens)
4. 0.65 µm: LRV ≥ 7 (L. brevis)
5. 0.8 µm: LRV ≥ 7 (S. cerevisiae)


• Physicochemical Testing:
1. USP Oxidizable Substances
2. USP <645> Conductivity
3. USP <643> TOC / Non-Volatile Residue

• Cleanliness:
1. USP <85> Bacterial Endotoxin Test
2. USP <788> Particulate Matter

• Biocompatibility:
1. USP <88> Biological Reactivity (Class VI Plastics)
2. USP <87> Cytotoxicity
3. ASTM F756-17 Hemolysis

• Sterilization Compatibility:
1. Autoclave: Up to 50 cycles at 125°C for 30 min
2. Steam-in-Place (SIP): Up to 30 cycles at 135°C for 30 min
3. Hot water or chemical sanitization options available

• Traceability:
1. Certificate of Conformance with each cartridge
2. Laser-engraved part number and lot number on each filter
3. Fully labeled bag and box for supply chain traceability

• Shelf Life:
1. 3 years from the date of manufacture