| | | |
| | |
| Materials of Construction |
|
| | |
| | |
| | |
| | |
| | 1/4 in. Hose Barb with double O-ring Seal |
| | 1/4 in. Hose Barb with double O-ring Seal |
|
|
| | ≥1240 mbar (18 psig) nitrogen with 60//40 % IPA/water |
| | ≥1240 mbar (18 psig) nitrogen with 60//40 % IPA/water |
|
| Nitrogen Diffusion at 23 °c |
| | ≤5 mL/min @ 1.7 bar (25 psig) in water after IPA prewet |
| | ≤10 mL/min @ 1.7 bar (25 psig) with water after IPA prewet |
|
| Maximum Inlet Pressure, bar (psid) |
| | 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C |
|
| Maximum Differential Pressure, bar (psid) |
| | Forward: 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 3.5 (50) @ 25 °C, intermittent |
|
| | <0.5 EU/mL as determined by the LAL test |
|
| | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology |
|
| | 20 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable |
|
| Component Material Toxicity |
| | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
|
| Good Manufacturing Practices |
| | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
|
| | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
|
| European Pressure Equipment Directive |
| | Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark. |
|