Sterile Sampling
A closed sterile sampling method is increasingly preferred by regulatory authorities over traditional sampling methods, such as glass bottles or steam-in-place (SIP) stainless steel valves. The NovaSeptum® GO sterile sampling system is designed to provide you with the flexibility and safety you need when sampling at any point in your aseptic or sterile biomanufacturing process. Its security features and closed design significantly reduce the risk of cross contamination while ensuring the highest level of protection for your samples, operators, and processes
The NovaSeptum® GO sterile sampling system answers all regulatory requirements, ensuring contamination control and patient safety, and supports global regulatory trends including process validation, process analytical technologies (PAT), and quality by design (QbD).
Why choose NovaSeptum® GO Sterile Sampling System for your Process?
- Closed and sterile – maintains aseptic conditions throughout your process
- Representative samples – delivers accurate sampling result
- Accurate collection of multiple samples from a single point of access
- Multiple container formats – provides adequate volume for regulatory requirements, storage, and future assessment
- Single-use containers – eliminates the need for cleaning and steam sterilization, saving time
- Security tag – prevents accidental actuation
- Sterile disconnect – prevents contamination during disconnection
- Easy to use – reduces need for training and operator bias
- Compliance with the most stringent and demanding regulatory and quality requirements
What is the NovaSeptum® GO Sterile Sampling System?
The system comprises a variety of container and volume options for testing and storage (bags, bottles, syringes); flexible connection options to enable new sampling points without significant modification of equipment; enhanced security and locking capabilities to prevent accidental actuation, as well as a complete validation package to support implementation.
Design a custom sampling solution that works for your aseptic process
- Customized assemblies – we work with you to design the best sampling solution for your process
- Assess total cost of ownership – our experts can help analyze and reveal hidden costs in your current process
Robust Sampling to Suit your Specific Needs in Each Step of your Aseptic Manufacturing Process
From the bioreactor to the final filling, at each step of the biomanufacturing of a molecule, the NovaSeptum® GO sterile sampling system provides biomanufacturers with consistent and representative samples to analyze pH, conductivity, cell viability, metabolites, monitor bioburden, and endotoxins level.
- Media preparation – monitor and adjust process parameters by sampling for pH, osmolality and/or conductivity
- Bioreactor – perform up to 45 representative samples and enable sterile additions to adjust or feed your process
- Bioburden reduction – excellent recovery of microorganisms from all sampling containers, with in-line connection holders that make it easy to add additional bioburden monitoring steps
- Chromatography – easy monitoring of bioburden, endotoxin, and quality prior to the next processing step protecting expensive resins from contaminants
- Sterile filtration – sample to demonstrate the effectiveness of your sterile filtration, validated sampling containers ensuring no impact to endotoxin recovery, minimize sample volume of valuable product
- Final fill – seamless integration into your final fill process, high level of security, representative samples
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