From media preparation through final sterile filtration and filling, the NovaSeptum® sampling system enables closed, sterile and consistent sampling that is customizable to fit your process. With a variety of holders, sampling containers and potential configurations, you have complete flexibility and assurance of robust, reliable monitoring and quality assurance.
And with our unique, patented system, you not only get sterile and accurate samples, but faster turnaround time between samples, while minimizing product loss and contamination risk. A simple and consistent design means reduced operator error and fewer procedures to validate. See the shared benefits for your implementation.
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Why should you use NovaSeptum® to sample your process?
Enable multi-sampling without risk of contamination
Collect accurate and multiple samples for process monitoring from a single point of access
Avoid lengthy hold-ups and the risks associated with steam sterilization
Eliminate the need for steam on assemblies and tube welding for pulling samples
Truly sterile sampling at any and every point in production
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The most important step of your medium preparation is ensuring that all required specifications are met, prior to forward processing. The NovaSeptum® Sterile Sampling System enables fast and easy collection of representative samples, so that pH, osmolality and/or conductivity can be analyzed. If the analysis indicates that key parameters need to be adjusted, the NovaSeptum® system can also be used for sterile additions and process adjustments.
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The NovaSeptum® Sampling system allows a high number of representative samples (up to 45), without compromising the sterility of the sample, or the process from which the sample is collected. It also enables sterile additions to adjust or feed the process.
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NovaSeptum® inline holders provide an easy way to add additional bioburden monitoring steps within your process. All sampling containers have been proven to provide excellent recovery of microorganisms for proper assessment of bioburden reduction.
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Through the use of tank or inline connectors, you can easily monitor bioburden, endotoxin and product quality prior to your next chromatography or processing step, while protecting expensive resins from contaminants.
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Bioburden monitoring is critical at this step. The NovaSeptum® Sterile Sampling system helps demonstrate effectiveness of your sterile filtration, while minimizing valuable sample volume. Additionally, NovaSeptum sampling containers have been validated to ensure no impact to endotoxin recovery.
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Whether your final fill process is stainless steel, single-use or hybrid, the NovaSeptum® Sampling System enables seamless integration of sampling capabilities, while ensuring completely representative samples and a high level of sterility.
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Shared benefits for your implementation
Easily monitor each process step for critical parameters Supports Quality by Design (QbD) and Process Analytical Technology (PaT)
Variety of container options validated to support accurate recovery during analytical testing and long term storage, even at -80°C
Protect your operators from biohazard, with a closed sampling system and use of the NovaSeal™ sterile disconnect crimping tool
Complete validation package to support implementation
BioReliance® Validation Services for testing, compatibility studies, validation, regulatory support, and more
Several holder options, both standard and custom, to enable addition of new sample points without significant equipment modification
Save valuable product by sampling only what is needed with accuracy (bottles, syringes)
From your bioreactor to final sterile filtration, the NovaSeptum® sampling system lets you sample processes the way you want. Flexible formats and volumes adapt to your process for robust, reliable monitoring and quality assurance.