Sterile and Aseptic Sampling Solutions
A robust process with consistent, high-quality output depends on reliable sampling methods. Implementing sterile and aseptic sampling solutions in pharmaceutical and biopharmaceutical processes minimizes contamination risks and enables accurate, representative sample collection for reliable process control. Our offerings include innovative manual sterile and automated aseptic sampling solutions designed to enhance efficiency and reliability at any step of your process.
Manual Sterile Sampling
Closed sterile sampling provides you with the safety you need when sampling in your manufacturing process. NovaSeptum® GO sterile sampling systems and NovaSeptum® SURe sterile sampling assemblies are closed sampling solutions that significantly reduce the risk of cross-contamination and give you representative samples throughout your process. Solutions include NovaSeptum® SURe sterile sampling assemblies for single-use manufacturing processes, or NovaSeptum® GO sterile sampling systems, designed to connect to any stainless-steel unit operation.
- Closed Design: Protects the integrity of your process and sample
- Easy to use: Plug and play options with a choice of connections and a range of containers
Explore NovaSeptum® SURe assemblies for single-use processes
Explore NovaSeptum® GO systems for stainless steel or multi-use processes
View the complete product offering here
Automated Aseptic Sampling
Automated sampling systems facilitate frequent measurements with maximized efficiency and minimal operator involvement in both upstream and downstream processing. Our MAST® Autosampling Solution enables on-line, near real-time analytics, supporting comprehensive process understanding and improved process control.
- Efficient: Increases sampling frequency, reduces turnaround times, and minimizes operator touchpoints
- Reliable: Ensures rapid sample transfer and traceability while maintaining sample source sterility
ROBUST SAMPLING FOR EVERY STEP OF YOUR ASEPTIC MANUFACTURING PROCESS
From bioreactor to final filling, NovaSeptum® sterile sampling provides biomanufacturers with consistent and representative samples to analyze pH, conductivity, cell viability, metabolites, monitor bioburden, and endotoxins level.
Monitor and adjust process parameters by sampling for pH, osmolality and/or conductivity.
Enable aseptic fluid additions to adjust or feed your process.
Excellent recovery of microorganisms from all sampling containers, with in-line connection holders that make it easy to add additional bioburden monitoring steps.
Easy monitoring of bioburden, endotoxin, and quality prior to the next processing step protecting expensive resins from contaminants.
Sample to demonstrate the effectiveness of your sterile filtration, validated sampling containers ensuring no impact to endotoxin recovery, minimize sample volume of valuable product.
Seamless integration into your final fill process, high level of security, representative samples.
To select the best single-use sampling solution for your process, first consider your preferred connection type: heat welding or aseptic connection. The pre-configured assembly is then easily integrated into your process via C-Flex® tubing or an AsepticQuik® connector.
Then identify the appropriate sampling container based on sample volume, type of assay, storage condition, and other key parameters in your sampling plan. Our NovaSeptum® SURe sterile sampling assemblies are standard single and manifold units of three or five containers available in bags, bottles, syringes, or conical tubes.
Choose the holder that fits your process: Tri-clamp (TC), In-line or In-Gold®. TC holders are also available preloaded with various container types
Choose from a range of bottles, bags, syringes, and conical tubes. These come in a variety of sizes and configurations – single sampling, manifold or preloaded.
Ensure sterility throughout the process. Disconnect your samples using the Novaseptum® manual crimping tool.
Designed to maximize ease of use, we have accessories available such as bag racks, port plugs, and security tags.
The MAST® Autosampling Solution is an advanced automated aseptic sampling tool designed to enhance efficiency and control in biopharmaceutical processes. By enabling direct collection and delivery of samples from multiple sources to various analytical destinations, this versatile solution accelerates turnaround times, reduces operator touchpoints, and minimizes contamination risks. It integrates seamlessly with other process analytical technology (PAT) tools for comprehensive monitoring and is configurable to fit various processes and scales. As a GMP-ready solution, it ensures compliance with stringent regulations while providing on-line, near real-time analytics of critical process parameters and efficient resource utilization.
Related Videos
Related Product Resources
- White Paper: Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective
There are significant consequences associated with microbial contamination during biopharmaceutical manufacturing. Contamination increases risks for the operator, the company, and potentially the patient, all of which can result in significant negative impact.
- Application Note: Microbial Integrity of NovaSeptum® Sampling Systems upon Performance of Multiple Sampling Actuations
The NovaSeptum® and NovaSeptum® GO sampling systems are a family of products designed for singleuse sterile sampling throughout the biomanufacturing process.
- User Guide: NovaSeptum® and NovaSeptum® GO Sampling Units
This user guide provides installation and use instructions
- Datasheet: NovaSeptum® GO Sterile Sampling System
To demonstrate the safety and integrity of your product, you need a standard-setting sampling solution that provides the flexibility to sample throughout your entire process. I
- Datasheet: NovaSeptum® SURe Sterile Sampling Assemblies
NovaSeptum® SURe single-use sterile sampling assemblies are designed to protect your single-use process from potential cross-contamination ensuring representative samples.
- Brochure: NovaSeptum® GO Sterile Sampling System
Continuing to set the sampling standard, our NovaSeptum® GO sterile sampling system is equipped with additional features for even safer sampling throughout your entire process.
- Technical article: Enhance Bioprocess Sampling with MAST® Autosampling Solution
Explore the MAST® Autosampling Solution for efficient, automated sampling in bioprocesses, supporting higher measurement frequency and reduced process risk.
- Datasheet: MAST® Autosampling Solution
The MAST® Autosampling Solution is a versatile & modality-agnostic aseptic autosampling solution for reliable on-line and near real-time sample analysis.
- White Paper: Automated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream Bioprocessing
This white paper focuses on PAT and the use of automated sampling technology to accelerate analytical and quality control methods and provide an approach for access to in-line data to monitor processes in real time.
- Application Note: Enabling Accelerated Raman Model Calibration for Seamless and Reproducible Real-Time Monitoring by Combining Raman and Automated Sampling Technologies
Explore how automated sampling can accelerate the integration of a Raman analyzer for a bioreactor application, speeding up the Raman model building phase, and facilitating in-line, real-time monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs) during the manufacturing process.
- White Paper: Accelerate Process Development with Automated Aseptic Sampling
This whitepaper describes evaluation of the MAST® Autosampling Solution as part of an automated PAT system implemented by Takeda Pharmaceuticals.
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