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.

• Closed Design: reduces risk of contamination and delivers representative samples
• Flexible: Choice of multiple connection and container formats makes it suitable for most processes. Multiple samples possible from a single point of access.
• Easy to Use: Plug and play system with single-use containers
• Secure: Security tags prevent accidental actuation
• Compliant: in line with the most stringent and demanding regulatory and quality requirements
• Sterile Disconnection: crimping tool prevents contamination

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, conical tube); 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.

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

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

For more information, please contact your local representative.

Sampling for Risk Mitigation

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

Sampling Operation and Process Optimization

User Guide: NovaSeptum^® and NovaSeptum^® GO Sampling Units
Webinar: Crimp Cleanliness and Microbial Integrity During Sterile Sampling
Webinar: Improve Your Process Management with Single-use Sampling

Product Specification

Datasheet: NovaSeptum^® GO Sterile Sampling System
Brochure: NovaSeptum^® GO Sterile Sampling System

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MAST^® Platform for automated, aseptic on-line sampling