NovaSeptum® SURe Assemblies for Single-Use Bioprocess Sampling
NovaSeptum® SURe sterile sampling assemblies are closed sampling solutions designed for single-use processes. These innovative systems ensure process integrity, minimize the risk of cross contamination from collection to analysis, and can be used for sampling throughout the drug manufacturing process.
Most NovaSeptum® SURe standard assemblies are stocked and ready-to-ship. If standard designs do not meet your requirements, connect with a Technical Specialist to explore a custom solution tailored to your needs.
Benefits of NovaSeptum® SURe Sampling Assemblies
Quality you can trust: Leveraging our global quality systems and the Emprove® Program, our NovaSeptum® SURe Sampling Systems come with extensive documentation and regulatory support, facilitating your risk assessment and process control.
Closed product design ensures process integrity and representative samples.
Easy connection and disconnection to any single-use process with industry-standard AseptiQuik® or MicroCNX® connectors or heat weldable C-Flex® or PVC tubing.
Multiple containers with different size options, in single or manifold designs for maximum flexibility in both development and manufacturing environments.
If you are using MAST® Autosampling Solution, the NovaSeptum® sampling technologies are the preferred option for secure sample collection for sterility, bioburden or endotoxin testing.
Configure Your Novaseptum® SURe Sterile Sampling Assembly
Step 1
Select Your Connection
First consider the best connection type to easily integrate the sampling assembly into your single-use process.Step 2
Choose Your Container Format
Containers should be selected based on sample volume, type of assay, storage condition, and other key parameters in your sampling plan.Step 3
Optional Accessories
Designed to maximize ease of use, and includes volume indicator, transport and storage case, caps.Select Your Connection
First consider your connection type. Standard assemblies are easily integrated into your process via C-Flex® tubing, PVC tubing or an AseptiQuik® S connector.
The AseptiQuik® genderless connector enables fast and easy fluid transfer. Choose between different AseptiQuik® connectors options: S, S High Temperature and G. MicroCNX® connector is also available for a sterile connection.
C-Flex® tubing for connection to your processes via heat welding.
Designed specifically for sampling during manufacturing of Autologous Cell Therapy (ACT), PVC DEHP-free tubing allows sterile connection through thermowelding. Combined with our Accurate Volume Syringe, it supports precise volume accuracy and drainage capability with an integrated MillexTM air vent, ensuring that as few cells as possible are left behind.
Select the Right Container Option
Standard NovaSeptum® SURe sterile sampling assemblies are single and manifold units of three or five containers available in bags, bottles, syringes, conical tubes or transfer units. Most NovaSeptum® SURe standard assemblies are stocked and ready-to-ship. If the standard designs do not meet your requirements, connect with a Technical Specialist to design a custom solution tailored for your sampling need.
Find additional information on containers in our Technical Article “Sterile Sampling Containers for Representative Sampling and Reduced Risk”.
High Purity Bag
- Pureflex® bag. Polyethylene contact layer
- 50 | 100 | 250 | 1000 mL
Bottle
- Polyethylene terephthalate glycol (PETG) bottle
- 60 | 125 | 250 | 500 mL
Accurate Volume Syringe
- Polycarbonate and Silicone
- 5 | 20 mL
Conical Tube
- 15 mL Polystyrene, 50 mL Polypropylene
- Offered with or without dip tube
Transfer Units
- 2 mm trigger
- AseptiQuik® S-HT connector
Optional Accessories
Find additional information in the NovaSeptum® SURe assemblies data sheet.
Crimping Tool
- To securely seal and enable leak free disconnection
Case
- For transport, storage and freezing of High Purity Bags
Other Accessories
- Volume Indicator: for High Purity Bags
- Protector Caps: for crimped tubes
- Centrifuge Caps: for 15 and 50 mL conical tubes
Tailor your sampling assemblies to your needs
If our standard designs do not meet your process requirements, explore a configure-to-order or custom solution.
Do you need a different container size, a mix of container types, additional containers in the same assembly, or another modification to our standard products? Design your sampling assembly using a predefined database of standard, qualified components.
Contact your local representative to explore additional configurations and let our experts help you design the right solution for your sampling plan.
Related Webinars
In this webinar we will explore the regulatory framework that guides sampling methodologies and outline the key qualifications necessary for effective sampling assembly, including system integrity evaluations.
In this webinar we will focus on an automated sampling system and its utilization in perfusion cell culture for upstream process development. We will demonstrate an increased frequency of data acquisition for the online measurement of CPPs and automation of a sample processing workflow to reduce the time to measure CQAs in perfusion cultures.
This webinar explores how automation strategies and control schemes facilitate rapid analytical results, crucial for managing glycosylation variability that affects product quality.
Related Articles
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Related Documents
- Data Sheet: 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.
- User Guide: NovaSeptum®, NovaSeptum® GO and NovaSeptum® SURe Sampling Units
This user guide provides installation and use instructions.
- Data Sheet: NovaSeal™ & NovaSeptum® Crimping Tools
NovaSeal™ pinch pipes ensure that sterility is maintained and that the fluid is securely protected from the outside environment at all times.
