• Closed sampling eliminates the risk of cross contamination
• Easy to use and handle
• Unique and patented sampling system
• Disposable unit
• No cleaning and/or sterilization between samples
• Sampling volumes of 5, 20, 50, 100, 250, and 1000 mL
The patented NovaSeptum sampling system is ideal for general fluid and cell culture sampling from aseptic and sterile processes. The NovaSeptum AV units meet the sampling demands of today’s high value biotherapeutic products with small, accurate volume sampling capability. The NovaSeptum units are ideal for obtaining larger volume sampling of up to 1000 mL. The sterile NovaSeptum sampling systems are easy to validate, handle and dispose of after each sampling. Unlike the majority of sampling methods that require an initial flushing before sampling, the NovaSeptum systems sample fluid directly from the batch without requiring an initial flush. The aseptic design and built-in safety mechanisms of the NovaSeptum sampling system eliminate the risk of cross contamination during sampling and handling. A range of NovaSeptum holders are available to connect the sampling units to a tank or pipe using the NovAseptic® connector or other standard connections.
Safe, Disposable Sampling System
The single use, disposable NovaSeptum sampling units eliminate the time and expense associated with cleaning and sterilizing traditional sampling devices. The closed design of the NovaSeptum system ensures your sample will be isolated from point of sample to analysis eliminating the risk of cross contamination.
NovaSeptum Sterile Sampling System
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The NovaSeptum single- and multi- sampling systems are available for high purity applications in sizes from 50 mL to 1000 mL. The single sampling container configurations can also be used in autoclavable applications.
The NovaSeptum systems offer a broad range of sampling solutions.
General and Cell Culture Sampling
Both the NovaSeptum general and cell culture sampling systems can be configured for high purity or autoclavable sampling applications in sizes from 5 mL to 1000 mL. For high purity applications, the NovaSeptum units are available in either single or multiple sampling container configurations. The autoclavable NovaSeptum units are available in single sampling container configurations. A wide range of holders and connectors are also available.
High Purity Units
The high purity sampling units are ideal for sterility testing, bioburden testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications and applications requiring very low affinity for proteins, complex carbohydrates, or small molecules.
Autoclavable Units
The sampling units for autoclavable applications are suitable for various general sampling including biological testing, chemical analysis and when it is necessary to autoclave the vessel.
Accurate Volume Units
The unique syringe design of the NovaSeptum AV units is ideally suited for fluid and cell culture sampling in applications that require small and accurate sample volumes including high-value biotherapeutics. It also enables operators to directly dispense sample products with milliliter accuracy for testing.
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The NovaSeptum AV sampling units are available in 5 mL and 20 ml syringe sizes.
NovaSeptum Sterile Transfer System
Sample Transfer Units
Designed to aseptically move liquid from one vessel or container to another, the closed design of the NovaSeptum transfer units is ideal for applications such as pH regulation and fermentation inoculation.
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The NovaSeptum Transfer System is available as a sampling unit or tubing application.
Flow Rates to Meet Your Sample Type
The NovaSeptum systems are available with either 1 mm or 2 mm needle. The general sampling systems include a 1 mm diameter needle in the septum, which is suitable for the majority of sampling applications. The cell culture sampling systems include a 2 mm diameter needle enabling significantly higher flow rates, which are often required in applications such as bacterial counting and sampling from bioreactors.
A Wide Range of Holders
The NovaSeptum family of holders offers a quick and easy connection to any tank or piping configuration.
• The TC holder is designed to fit a tri-clamp connection. For an optimal aseptic solution, use with the NovAseptic connector
• The Ingold® holder is designed to fit an Ingold connection with a standard 25 mm Ingold tube size
• The In-line, TC holder is designed to be TC connected to a pipe for in-line sampling
• The In-line Butt-end holder is designed to be welded to a pipe for in-line sampling
NovAseptic Connectors
Connect Easily and Securely
The NovAseptic connectors provide an ideal connection for a NovaSeptum holder with a TC flange. These flush-mounted sanitary connectors eliminate dead legs and hold-up volume improving cleanability and steamability as well as making validation easier. Contact Millipore Technical Service for ordering information.
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| NovaSeptum Sterile Sampling Units |
| High Purity | Autoclavable | Accurate Volume | Transfer System |
| Maximum Sampling Pressure, bar | 0.5 | 0.3 | 0.5 | 0.5 |
| Sampling Unit Volume, mL | 50–1000 | 50–1000 | 5 and 20 | 250 |
| Temperature Range, °C | -20 to 50 | -20 to 125 | Single 5 mL: -20 to 123 Single 20 mL: -20 to 121 Multi: -20 to 50 | Polyethylene: -20 to 50 Silicone: -50 to 95 |
| Materials of Construction |
| Septum unit | Septum: Medical grade platinum-cured silicone Body: Polyester Cannula: ASTM 316L stainless steel | | |
| Sampling bag | Polyethylene film | Polypropylene film | – | Polyethylene film |
| Tubing | Polyethylene | Silicone | Medical grade platinum-cured silicone | Polyethylene or silicone |
| Drainage bag | Polyethylene film | – | Polyethylene film | – |
| Syringe | – | – | Polycarbonate, medical grade, platinum-cured silicone, medical silicone fluid | – |
| Fittings |
| Inlet | Septum unit with 1 mm or 2 mm needle |
| Outlet | Tubing: 3-piece Luer, containing a male, female and an injection site | Tubing: Male Luer | Female or Male Luer | Tubing: 3-piece Luer, containing a male, female and an injection site or a septum unit with a 1 mm or 2 mm needle |
| Autoclaving | N/A | Can be autoclaved empty | Can be autoclaved empty | N/A |
| 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 SS-EN ISO 14644-1 standards |
| Sterilization | The sampling units are sterilized by beta irradiation at > 25 kGy according to ISO 11137 TIR No. 27 |
| Bacterial Endotoxin | Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test |
| NovaSeptum Holders |
| TC | Ingold | In-line, TC | In-line, butt-end |
| Materials of Construction |
| Wetted materials | Stainless steel 316L, EN 1.4435 | Stainless steel 316L, EN 1.4435 | Stainless steel 316L, EN 1.4435 | Stainless steel 316L, EN 1.4435 |
| Magazine (blue plastic holder portion) | Polyphenylene sulfide (PPS) | Polyphenylene sulfide (PPS) | Polyphenylene sulfide (PPS) | Polyphenylene sulfide (PPS) |
| Autoclavable/ Steam-in-Place | Yes | Yes | Yes | Yes |
| Tube Standards | — | — | ASTM® A270, DIN 11850, Reihe 2 | ASTM A270, DIN 11850, Reihe 2 |
| NovAseptic Connectors |
| Materials of Construction |
| Wetted materials | Stainless steel 316L, EN 1.4435 |
| Tube Standards | ASTM A270, DIN 11850, Reihe 2 |
| Connection Type | Butt-end or TC |