NovaSeptum® SURe Sterile Sampling Assemblies
For single-use manufacturing processes, where aseptic connection and disconnection is necessary.
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NovaSeptum® GO Sterile Sampling SystemsA secure and flexible system for sampling fluids throughout sterile and aseptic processesSaiba mais >> |
The NovaSeptum® SURe single-use sterile sampling assemblies are designed to protect your single-use process from potential cross-contamination ensuring representative samples.
Features
- Product design ensures process integrity and a representative sample from single-use manufacturing processes.
- Ideal for sterility, bioburden and endotoxin testing, chemical analysis, pH analysis, and any other quality testing requirement.
- Available as standard off-the-shelf products enabling fast delivery to your site.
Select your Assemblies
First consider your preferred connection type: heat welding or aseptic connection. The pre-configured assembly is easily integrated into your process via C-Flex® tubing or an AseptiQuik® S connector.
Then identify the appropriate sampling container based on sample volume, type of assay, storage condition, and other key parameters in your sampling plan. The assemblies are standard single manifold units of three and five containers available in bags, bottles, syringes, or conical tubes. Optional accessories are also available for enhanced operator experience.
| NovaSeptum® SURe Sterile Sampling Assemblies | |||||
| Conical Tube | High Purity Bag | Bottle | Syringe | Tube Transfer (High Temperature) | |
| Sampling Unit Volume | 15 mL | 100 mL | 60 mL | 5 mL and 20 mL | N/A |
| Maximum Pressure Conditions (at 25°C ) | 0.30 bar (4.35 psi) | 0.30 bar (4.35 psi) | 0.30 bar (4.35 psi) | 0.50 bar (7.25 psi) | N/A |
| Temperature Range | |||||
| C-Flex® designs | 2-8 to 50°C (36-46° to 122°F) | -80° (when used with a NovaSeptum® Case) to 50 °C (-112 to 122 °F) | -80 to 50 °C (-112 to 122 °F) | -20 to 50°C (-4 to 122 °F) | –80 to 125 °C (–12 to 257 °F) |
| AseptiQuik® S designs | 4°C and 40°C (39°F and 104°F) | ||||
| Materials of Construction | |||||
| Fluid Contact Layer: | Polystyrene | Polyethylene film (PureFlex film) | Polyethylene Terephtalate Glycol | Polycarbonate, platinum-cured silicone, medical silicone fluid | Polycarbonate, platinum-cured silicone, medical silicone fluid |
| Tubing: | Medical grade Thermoplastic | Thermoplastic elastomer (TPE) | Thermoplastic elastomer (TPE) | Silicone | Silicone |
| Drainage Bag | Polyethylene film (PureFlex film) | N/A | |||
| AseptiQuik® S | Polycarbonate | ||||
| Bottle cap | N/A | N/A | Polypropylene | N/A | N/A |
| Fittings | |||||
| AseptiQuik® S Inlet Tubing: | Cap | TPE | Cap | Female and male Luer-Lok™ | |
| C-Flex® Inlet Tubing: | Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site | Trigger Septum: Platinum-cured silicone Body: Polyester Cannula: ASTM 316 L Stainless steel |
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| Outlet Tubing: for AseptiQuik® S and C-Flex® designs | Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site | ||||
| Autoclaving* | Not autoclavable | Yes | |||
| USP<88>Class VI | All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo. | ||||
| 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 standards. | ||||
| Sterilization | |||||
| C-Flex® designs | Gamma irradiation at ≥ 25kGy according to ISO® 11137 | Beta irradiation at ≥ 25kGy according to ISO® 11137 | Gamma irradiation at ≥ 25kGy according to ISO® 11137 | Beta irradiation at ≥ 25kGy according to ISO® 1137 | N/A |
| AseptiQuik® S designs | Gamma irradiation at ≥ 25kGy according to ISO® 11137 | ||||
| Bacterial Endotoxin | Aqueous extraction contains | ||||
| * Autoclaving can only be performed on empty bags. | |||||
| NovaSeptum® Case | |||||
| Compatible with Sampling Unit Volume | 100mL | ||||
| Maximum Pressure Conditions (at 25°C) | 0.50 bar (7.25 psi) | ||||
| Operating Temperature | -80° to 37 °C (-112 to 98,6 °F) | ||||
| Materials of Construction | Amorphous Polyethylene Terephtalate (APET) noble | ||||
| Dimensions (length x width x height) | 442 x 275 x 36 mm (17,4 x 10,8 x 1,4 in.) | ||||
| Port Plug | |||||
| Material of Construction | Platinum-cured silicone (wetted part) + polyester for the pin | ||||
| Operating Temperature | 0 to 134 °C (32 to 273 °F) | ||||
| NovaSeptum® Manual Crimping Tool | |||||
| Materials of Construction | |||||
| Body | Aluminum | ||||
| Lower die | Vanadis with hardened special surface treatment | ||||
| Upper die | Vanadis with hardened special surface treatment | ||||
| Screws and Bearings | Stainless steel | ||||
| Miscellaneous Accessories | |||||
| Materials of Construction | |||||
| Volume Indicator Ruler, Crimped Tube Protector Caps | PVC | ||||
| First actuation locking tag | Polyamide and stainless steel | ||||
| Operating Temperature | |||||
| Volume Indicator Ruler | –15 to 55 °C (5 to 131 °F) | ||||
| Crimped Tube Protector Caps | –20 to 60 °C (–4 to 140 °F) | ||||
| Dimensions | Thickness (µm) | Volume (mL) | Length x Width (mm) | ||
| Volume Indicator Ruler | 200 ±20 | 100 | 169 ±1 30 ±1 | ||
| Crimped Tube Protector Caps | 1.00 ±0.25 | N/A | 12.7 ±2.00 x 8.00 ±0.25 | ||