|
|
Per 10-inch Cartridge |
| Materials of Construction |
| Filter |
Hydrophobic PTFE |
| Supports |
Polypropylene |
| Cage and End Caps |
Polypropylene |
| Core |
Polysulfone |
| O-ring |
Silicone |
| Filtration Area, m2 |
0.66 |
| Maximum Differential Pressure, bar (psid) |
Forward: 4.1 (60) @ 25 °C; 0.35 (5) @ 145 °C |
| Virus Aerosol Retention |
Retention of a worst case challenge of the model bacteriophage Φ X-174 was
complete at challenge levels up to 107 to 1010 virus
particles at 1400 sL/min (50 scfm) after 200 steam sterilization
cycles of 30 minutes at 145 °C |
| Bacterial Growthrough |
Prevention of bacterial growthrough by Brevundimonas diminuta for at
least 21 days @ a challenge level ≥1 x
107 CFU/cm2 |
| Toxicity |
Component materials meet the requirements of the USP Class VI Biological
Test for Plastics. The cartridges also meet the requirements of the USP General
(Mouse) Safety Test. |
| Sterilization |
200 forward SIP cycles of 30 min @ 145 °C |
| Integrity Test |
| Bubble Point |
≥965 mbar (14 psig) nitrogen with 70/30 % IPA/water |
| Nitrogen Diffusion |
≤60 mL/min @ 410 mbar (6.0 psig) in 70/30 %
IPA/water |
| HydroCorr |
≤0.40 mL/min per 10-inch cartridge with water @ 690 mbar
(10 psig) |