NovaSeptum® Sterile Sampling Systems
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Overview
Specifications
Ordering Information
Documentation
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Benefits
- Disposable and closed unit, ensuring the security of the process, the operator and the sample
- Easy to use and handle, reducing operator trainer time
- Pre-sterilized, eliminating the need for cleaning and/or sterilization between samples
- Flexible, accommodating a wide range of sampling volumes and formats
- Ability to access any location to collect samples
- Facilitate compliance with the most stringent and demanding regulatory and quality requirements
Sampling your product is critical throughout the manufacturing process. An imprecise or false positive result can lead to quarantine, as well may also require a repeat of the analysis. With the NovaSeptum® sampling system, contamination is no longer a threat. Ideal for aseptic and sterile processes, the closed design ensures your sample will be isolated from point of sample to analysis. NovaSeptum® also allows for savings of precious materials with its compact, no dead leg, design.
The wide range of standard and custom connectors guarantees the ability to collect sample everywhere needed. The high purity sampling units are ideally suited for sterility, bioburden and endotoxin testing, chemical analysis, and applications requiring very low affinity for proteins, complex carbohydrates or small molecules. It is available as a flat bag for easy storage and hanging.
Sampling high value products requires the ability to extract Accurate Volume (AV) of sample. The NovaSeptum® AV unique syringe design allows for small accurate samples from 1 up to 20 mL eliminating valuable product waste.
Transfer line are simple and efficient to collect multiple non critical samples.
| 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. |