NovaSeptum® GO Sterile Sampling Systems
A secure and flexible system for sampling fluids throughout sterile and aseptic processes
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A secure and flexible system for sampling fluids throughout sterile and aseptic processes 간단히
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개요
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관련 제품 및 어플리케이션
Benefits
- Sampling actuation evidence and control, ensures process integrity and a representative sample
- Closed, easy to use and validate, the system improves operational efficiency and reduces risk of contamination
- Presterilized, eliminating the need for cleaning and/or sterilization between samples
- Preconfigured or configure on site
- Accommodates a wide range of holders and sampling configurations for adaptable, flexible sampling throughout your process
To demonstrate the safety and integrity of your product, you need a standard-setting sampling solution that provides the flexibility to sample throughout your entire process. It is critical that samples are consistently representative. Therefore the method used should be designed to protect against the risk of potential cross contamination in both your formulation and sample. Our NovaSeptum® GO sterile sampling system addresses these requirements.
A closed, sterile sampling method can significantly reduce your sampling risk and is recommended by regulatory bodies.
Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system is designed with your needs in mind. The innovative, closed design ensures your sample will be isolated from point of sample to analysis, reducing the risk of losing valuable product while maintaining the integrity of your fluid samples. NovaSeptumm® GO security capabilities also provide an extra level of confidence in your risk mitigation strategy by allowing the device to be locked and containers sealed when not in use, keeping your sample safe and process under control.
| NovaSeptum® GO Sterile Sampling Units | ||||||
| Conical Tube | High Purity Bag | Autoclavable Bag | Bottle | Syringe | Tube transfer | |
| Sampling Unit Volume | 15 mL and 50 mL | 50 mL to 1000 mL | 50 mL to 1000 mL | 60, 125, 250, and 500 mL | 5 mL and 20 mL | Not applicable |
| Maximum Pressure Conditions (at 25°C ) | 0.50 bar for the single unit 0.30 bar for the multi-sampling unit with drainage bag |
0.50 bar (7.25 psi) up to 250 mL 0.30 bar (4.35 psi) for 1000 mL and multi sampling |
0.30 bar (4.35 psi) | 0.50 bar (7.25 psi) 0.30 bar for the multi-sampling unit |
0.50 bar (7.25 psi) | 0.50 bar (7.25 psi) |
| Temperature Range | 8 to 60°C (46° to 140°F) | 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) | 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) |
Thermoplastic elastomer (TPE): -20 to 50 °C (-4 to 122 °F) Silicone : -50 to 95 °C (-58 to 203 °F) C-Flex®: -73 to 132 °C (-99 to 270 °F) |
| Materials of Construction | ||||||
| Trigger | Septum: Platinum-cured silicone; Body: Polyester; Cannula: ASTM® 316 L Stainless steel | |||||
| Sampling Bag: | N/A | Polyethylene film (PureFlex film) | Polypropylene film | N/A | N/A | N/A |
| Fluid Contact Layer: | Polystyrene (15 mL) Polypropylene (50 mL) | Polyethylene film (PureFlex film) | Polypropylene film | Polyethylene Terephtalate Glycol | Polycarbonate, platinum-cured silicone, medical silicone fluid | N/A |
| Tubing: | Medical grade Thermoplastic Elastomer |
Thermoplastic elastomer (TPE) | Silicone | Thermoplastic elastomer (TPE) | Silicone | Thermoplastic elastomer (TPE), silicone or C-Flex® tube |
| Drainage Bag (valid for Multi-Sampling Application): | Polyethylene film (PureFlex film) | Polyethylene film (PureFlex film) | N/A | Polyethylene film (PureFlex film) | Polyethylene film (PureFlex film) | N/A |
| Bottle cap | N/A | N/A | N/A | Polypropylene | N/A | N/A |
| Fittings | ||||||
| Inlet Tubing: | Septum with a 2 mm needle | |||||
| Outlet Tubing: | Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site | Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site | Tubing: Male Luer-Lok™ with female cap | Cap | Female and male Luer-Lok™ | 3-piece Luer-Lok™, containing a male, female and an injection site |
| Autoclaving* | NO | Not autoclavable | Autoclavable | Not autoclavable | Single: Yes Manifold: No |
Not autoclavable |
| USP |
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 | Gamma irradiation at ≥ 25kGy according to ISO® 11137 | Beta 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® 11137 | Beta irradiation at ≥ 25kGy according to ISO® 11137 |
| Bacterial Endotoxin | Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test. | |||||
| * 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® GO Holder | |
| Materials of Construction | |
| Wetted Materials | Stainless steel 316L, EN 1.4435 |
| Magazine | GF reinforced Polysulfone (PSU) for 5 and 9 shot TC holders. Polyphenylene sulfide (PPS) for 1 shot TC, Ingold®, and in-line holders. |
| Safety ring | Polysulfone for 5 and 9 shot TC holders. Polyester for 1 shot TC, Ingold®, and in-line holders. |
| Autoclavable/Steam-in-Place | Yes |
| Tube Standards | |
| TC and Ingold® | N/A |
| In-line TC, Butt-end | ASTM® A270, DIN 11850 (Part 2) |
| Design Pressure: | 6 bar(g) (87 psi) |
| Design Temperature: | -80°C to 150°C (-112°F to 302°F) |