| NovaSeptum Sterile Sampling Units |
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| Maximum Sampling Pressure, bar |
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| | | Single 5 mL: -20 to 123 Single 20 mL: -20 to 121 Multi: -20 to 50 |
| Polyethylene: -20 to 50 Silicone: -50 to 95 |
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| Materials of Construction |
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| Septum: Medical grade platinum-cured silicone Body: Polyester Cannula: ASTM 316L stainless steel |
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| | | | Medical grade platinum-cured silicone |
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| | | | Polycarbonate, medical grade, platinum-cured silicone, medical silicone fluid |
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| | Septum unit with 1 mm or 2 mm needle |
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| | Tubing: 3-piece Luer, containing a male, female and an injection site |
| | | | Tubing: 3-piece Luer, containing a male, female and an injection site or a septum unit with a 1 mm or 2 mm needle |
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| | All components in contact with sampling liquid conform with USP <88> Class VI |
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| | Units are integrity tested at regular intervals during manufacturing |
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| | Assembled under ISO® Clean Room Class 8 conditions in a facility certified to SS-EN ISO 14644-1 standards |
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| | The sampling units are sterilized by beta irradiation at > 25 kGy according to ISO 11137 TIR No. 27 |
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| | Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test |
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