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).
White Paper: Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective
Application Note: Microbial Integrity of NovaSeptum® Sampling Systems upon Performance of Multiple Sampling Actuations
Poster: NovaSeptum® GO Sterile Sampling in Biomanufacturing: A Regulatory Perspective
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Strategy
Webinar: Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective
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.
For more information about NovaSeptum® GO sterile sampling system and our complete offering, please refer to our product Data Sheet.
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.
For more information, please contact your local representative.