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  • Filtration of LVPs and SVPs
  • Final Sterile Grade Filtration
  • Sterilization of Hormonal Injectables
  • Quality Buffer Preparation
  • Filtration of Water for Injectables (WFIs)
  • Solvent Filtration
  • Filtration of Non-protein solutions, Aqueous and organics chemicals
  • Easy identification & traceability
  • Reusable after multiple sterilization cycles
  • Wide chemical compatability

Materials of Construction

Membrane: Nylon
Housing: Polypropylene
Core: Polypropylene
End Connections: Polypropylene

Operational Parameters

Max Temp: 80 °C @ ≤ 2 Kg/cm²
Max Pressure: 3.5 Kg/cm² @ 25 °C
Autoclavable: 1 Autoclave cycle @121°C

Bubble Point

0.22µm:: ≥ 3447 mbar (50 psi) (with water wetted)
0.45µm:: ≥ 2069 mbar (30 psi) (with water wetted)
0.80µm:: ≥ 965 mbar (14 psi) (with water wetted)

Max Air Diffusion Flow (for 10″ Cartridge):

0.22µm: ≤ 20 mL/min @ 2483 mbar (36 psi) (with water wetted)
0.45µm: ≤ 20 mL/min @ 1517 mbar (22 psi) (with water wetted)
0.80µm: ≤ 20 mL/min @ 689 mbar (10 psi) (with water wetted)

Microbial Retention

0.22µm: LRV > 7 for Brevundimonas Diminuta
0.45µm: LRV > 7 for Serratia marcescens
0.80µm: LRV > 7 for Staphylococcus aureus

Regulatory Compliance

Endotoxin releasing: <0.25 EU/mL as determined by the LAL test
Particle release: Meets the requirements of WFI set by USP
Non-fiber releasing: Meets the criteria for a non-fiber releasing filter as per USP
Material toxicity: All components meet the requirements of the USP Reactivity Test for Class VI Plastics Filters meet the requirements of USP Biological Reactivity Tests in Vitro Cytotoxicity
Bacterial challenge test: Filters with the claim passed the bacterial challenge testing using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration 1x10⁷ CFU/cm² (0.22 µm) per ASTM F838-20.
Quality: Manufactured in accordance with ISO 9001 and ISO 13485 certified quality management system
Nylon Cartridge Filter CFNN_Nupore_Flow rate

Drug Specific Filter Validation Services

Through, nSure Validation Services, we offer a complete range of filter validation services to qualify your molecules with our Filters in accordance with the requirements listed in PDA TR#26 and in compliance with international regulatory bodies such as USFDA and EU GMP.

Filter Integrity Test
Bacterial Retention Testing (BRT)
Chemical Compatibility Test
Throughput Study
Extractables & Leachables
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Laboratory Testing
Clean Room Testing
Equipment Testing