Their housing, with a clear core and sleeve, is manufactu- red with co-polyester.
All materials meet ISO 10993 requirements for external com- municating devices, blood path indirect.
GVS’s upstream, high volume, fully automated manufactu- ring capabilities ensure on-time delivery of precise compo- nents. All GVS products are manufactured in an ISO Class 8, 100,000 cleanroom under GMP guidelines, offering com- plete manufacturing traceability and meeting ANSI/ISO standards. GVS is an ISO 13485 registered manufacturer
KEY CHARACTERISTICS
- Fast flow rates
- 96 hours throughput
- Compact size
- Unique cylindrical shape
BENEFITS
- Quantitative removal of particles and microorganisms greater than 0.22 µm
- Rated for 96 hour use
- Reliable air elimination
- Can be used with either a gravity or pump feed
- Proven clinical field performance
APPLICATIONS
Ivex, Nutrivex and 5-Ivex IV Filters are particularly suitable for the following filtration applications:
- Aqueous IV solutions
- IV therapy
- Chemotherapy
- Antibiotic therapy
- Nutrient admixture, TPN and lipid solutions (Nutrivex)
- Drug delivery therapy (recommended for oncology drugs)
- Apheresis solutions
- Dialysate for kidney dialysis
Biosafety
Materials comply with USP class VI-121°C test and ISO 10993
Dimensions
6.7 cm (2.6") inlet to outlet
4.66 cm (1.8") filter body Diameter: 1.7 cm (0.67") Weight: 6.5 gr. Effective filtration area
10.0 cm² PES
0.5 cm² PVDF Inlet/Outlet connectors Inlet: FLL
Outlet: Tube 3x4.1 mm
Materials of construction
Filter media: Hydrophilic PES, 0.22, 1.2 µm membrane Hydrophobic PVDF 0.1 µm
Housing
Clear PETG material (yellow core for Nvex)
Max operating pressure 3.1bar (45psi) for 60 seconds Operating temperature
55°C (131 °F)
Pore Size
0.2µm, 1.2µm, 5.0 µm
Minimum Water Bubble Point Ivex: 0.2µm: 3.1 bar Nutrivex: 1.2µm: 0.5 bar
5-Ivex: 5.0µm: 0.15 bar
Minimum Water Flow Rate
0.2 µm: 17ml/min @76cm (30°) water head height
1.2 µm: 167ml/min @76cm (30°) water head height
5.0 µm: 340 ml/min at 76 cm (30°) water head height
Air Flow
PVDF membrane: 70÷90 scc/min @ 190mbar
Water Breakthrough PVDF 5bar Bacterial Retention
Ivex: Brevundimonas diminuta Nutrivex: Candida albicans
Priming Volume
3ml
Pyrogenicity
<0.25 EU/ml using the LAL test method 96-Hours Throughput Ivex and Nutrivex filters do not show relevant loss in flow rate during 96-hour test
Sterilization Compatibility
EtO or Gamma (50kGy), e-beam
Self-priming instructions
Minimum Water Bubble Point Ivex: 0.2µm: 3.1 bar Nutrivex: 1.2µm: 0.5 bar
5-Ivex: 5.0µm: 0.15 bar
Minimum Water Flow Rate
0.2 µm: 17ml/min @76cm (30°) water head height
1.2 µm: 167ml/min @76cm (30°) water head height
5.0 µm: 340 ml/min at 76 cm (30°) water head height
Air Flow
PVDF membrane: 70÷90 scc/min @ 190mbar
Water Breakthrough PVDF 5bar Bacterial Retention
Ivex: Brevundimonas diminuta Nutrivex: Candida albicans
Priming Volume
3ml
Pyrogenicity
<0.25 EU/ml using the LAL test method 96-Hours Throughput Ivex and Nutrivex filters do not show relevant loss in flow rate during 96-hour test
Sterilization Compatibility
EtO or Gamma (50kGy), e-beam
For fastest priming procedure let the IVEX, Nutrivex and 5-Ivex filters free hanging in vertical position with the inlet con- nector in upper position than the outlet connector. Filter will be filled-up of liquid and eliminate air through the vent. After IVEX is filled-up of liquid it can work in any position.
Drug Compatibility
Ivex, Nutrivex and 5-Ivex show total compatibility with the most popular drugs:
Paclitaxel; Human Insulin; Heparin; Lidocaine Hydrochloride; Bupivacaine; Mannitol; 5-Fluorouracil
