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| NovaSeptum®Sterile Sampling Units | |||
| High Purity Flat Bag | Autoclavable Flat Bag | Bottle | |
| Sampling Unit Volume | 50 mL to 1000 mL | 50 mL to 1000 mL | 60, 125, 250, and 500 mL |
| Maximum Pressure Conditions (at 25°C ) | 0.50 bar (7.25 psi) up to 250 mL | 0.30 bar (4.35 psi) | 0.50 bar (7.25 psi) 0.30 bar for the multi-sampling unit |
| 0.30 bar (4.35 psi) for 1000 mL and multi sampling | |||
| Temperature Range | 50 mL to 250 mL: -80° (when used with a NovaSeptum Case) to 50 °C (-112 to 122 °F) 1000 mL: -20° to 50 °C (-4 to 122 °F) | -20 to 125 °C (-4 to 257 °F) | -80 to 50 °C (-112 to 122 °F) |
| Materials of Construction | |||
| Trigger | |||
| Septum: | Medical Grade platinum-cured silicone | ||
| Body: | Polyester | ||
| Cannula: | ASTM 316L Stainless steel | ||
| Sampling Bag: | Polyethylene film (PureFlex film) | Polypropylene film | Polyethylene Terephtalate Glycol |
| Fluid Contact Layer: | Polyethylene film (PureFlex film) | Polypropylene film | Polyethylene Terephtalate Glycol |
| Tubing: | Polyethylene | Silicone | Polyethylene |
| Drainage Bag (valid for Multi-Sampling Application): | Polyethylene film (PureFlex film) | Not Applicable | Polyethylene film (PureFlex film) |
| Fittings | |||
| Inlet Tubing: | Septum with a 1 mm or a 2 mm needle | ||
| Outlet Tubing: | Tubing: 3-piece Luer, containing a male, female and an injection site | Tubing: Male Luer with Female cap | Tubing: Male Luer Fitting and Female to Female Luer |
| Autoclaving* | Not autoclavable | Autoclavable | Not autoclavable |
| USP <88> Class VI | All components in contact with sampling liquid conform with USP <88> Class VI. | ||
| Integrity Testing | Units are integrity tested at regular intervals during manufacturing. | ||
| Assembly | Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 | ||
| Sterilization | The sampling units are sterilized by beta irradiation at ≥ 25 kGy according to ISO 11137 | The sampling units are sterilized by gamma irradiation at ≥ 25 kGy according to ISO 11137 | |
| Bacterial Endotoxin | Aqueous extraction contains | ||
| * Autoclaving can only be performed on empty bags. | |||
| NovaSeptum® Sterile Sampling Units and Transfer System | |||
| Syringe | Bag Transfer System | Tube Transfer System | |
| Sampling Unit Volume | 5 mL and 20 mL | 250 mL | Not applicable |
| Maximum Pressure Conditions (at 25°C) | 0.50 bar (7.25 psi) | ||
| Temperature Range | Single 5ml : -80 to 134 °C (-112 to 273 °F) Single 20ml : -80 to 121 °C (-112 to 250 °F) Multi: -20 to 50°C (-4 to 122 °F) | -80° (When used with a NovaSeptum Case) to 50 °C (-112 to 122 °F) | Polyethylene: -20 to 50 °C (-4 to 122 °F) Silicone : -50 to 95 °C (-58 to 203 °F) |
| Materials of Construction | |||
| Trigger | |||
| Septum: | Medical Grade platinum-cured silicone | ||
| Body: | Polyester | ||
| Cannula: | ASTM 316L Stainless steel | ||
| Sampling Bag: | Not Applicable | Polyethylene film (PureFlex film) | Not applicable |
| Fluid Contact Layer: | Polycarbonate, medical grade platinum-cured silicone, medical silicone fluid | Polyethylene film (PureFlex) | Not applicable |
| Tubing: | Silicone | Polyethylene | Polyethylene or Silicone |
| Drainage Bag (valid for Multi-Sampling Application): | Polyethylene film (PureFlex film) | Not Applicable | Not Applicable |
| Fittings | |||
| Inlet Tubing: | Septum with a 1 mm or a 2 mm needle | ||
| Outlet Tubing: | Tubing: male and female luer | Septum Unit with a 1 mm or 2 mm needle | 3-piece Luer, containing a male, female and an injection site |
| Autoclaving* | Single : autoclavable Multi : Not autoclavable | Not autoclavable | Not Autoclavable |
| USP <88> Class VI | All components in contact with sampling liquid conform with USP <88> Class VI. | ||
| Integrity Testing | Units are integrity tested at regular intervals during manufacturing. | ||
| Assembly | Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 | ||
| Sterilization | The sampling units are sterilized by beta irradiation at ≥ 25 kGy according to ISO 11137 | ||
| Bacterial Endotoxin | Aqueous extraction contains | ||
| * Autoclaving can only be performed on empty bags. | |||
| NovaSeptum® Case | |
| Compatible with Sampling Unit Volume | 50 mL, 100 mL and 250 mL |
| Maximum Pressure Conditions (at 25°C) | 0.50 bar (7.25 psi) up to 250 mL |
| Operating Temperature | -80 to 37 °C (-112 to 98.6 °F) |
| Materials of Construction | APET (Amorphous Polyethylene Terephthalate) noble |
| Sterilization | Non-sterile |
| NovaSeptum® Single-Use holder, TC 1.5 / 2“, 2 mm | |
| Holder and Magazine | PEI Black |
| Locking ring | PEI Orange |
| Screw | A2-A4 |
| Environmental | |
| Design Temperature, TC holder | Steam in place cycle at up to 134 °C (273 °F) or Autoclave during 1 hour at up to 134 °C (273 °F) (when applicable) |
| Traceability | The product and packaging label includes the catalogue number, lot number and expiration date. |
| Sterilization | Gamma irradiation between 25 kGy and 40 kGy |
| Component Material Toxicity | All wetted components comply with USP USP <88> Class VI. |
| Endotoxin level | < 2.15 EU/device for all wetted components |
| Assembly | This product is manufactured in a clean room environment complying with class 8 according to ISO® 14644-1. |
| Packaging | Each Single use pre-loaded holder is double packed. |