Linkit® AX Aliquoting Solution
Minimize filling time with an efficient aliquoting solution that pumps fluid to 10 bags simultaneously.
The Linkit® AX Aliquoting Solution is ideal for aliquoting small quantities of process fluids - fast, evenly, and reproducible batch-to-batch. The plug & play concept, combined with ready-to-use patented manifold design, minimizes operator effort and error and consistently distributes fluid between the 10 bags with an accuracy of ±5%. The solution is designed to address the pain points of manual filling and aliquoting applications without the need to heavily invest in big and complex equipment.
Watch how aliquoting can be simplified with the Linkit® AX Solution
Fast filling performance with a unique flow-through fluid design of the main hub.
QApp guides the operator during a filling operation, ensuring batch-to-batch repeatability.
Fully assembled, compact and small footprint solution - no need to handle bulky and complicated traditional manifolds.
Full end-to-end traceability in compliance to FDA directive 21 CFR part 11 and EU Annex 11.
Aliquoting is a common task in bioprocessing - often done manually, with all the pain points that accompanies the use of traditional bag manifolds: bulky, difficult to handle & manipulate and prone to operator error.
Fully automated aliquoting systems require considerable capital investment and are more suited to drug substance and drug product filling applications.
The Linkit® AX aliquoting system is the first simultaneous filling solution, offering fast filling with a distribution accuracy of ±5.1% and not requiring an initial high capital expenditure cost.
Attribute
Traditional Bag Manifold
High-End Automated Filling System
CAPEX
Low
Medium
High
Filling
Sequential
Set-up
Manual
Automation
None
Full
Operator Effort
Med-Low
Filling Time for 50 L Batch
6 Hours
30 min
1 - 2.5 Hours
Watch our video to see the innovative ways Linkit AX® is designed to simplify and speed up your aliquoting process.
Read about the challenges associated with liquid handling in cell and gene therapy processes and the introduction of novel solutions that simplify ali...
Over 10x faster. Less errors. Sustainable Scaleup. Read about the real results this large biopharma achieved using Linkit® AX.
Learn which factors are significantly impacting accuracy and how to optimize them.
The Linkit® AX Aliquoting System consists of four elements:
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A peristaltic pump connected and controlled by the balance.
A modern balance with a large and intuitive user interface, connectivity options for data extraction and 21 CFR part 11 compliant with a dedicated aliquoting QApp.
A software package developed to optimize filling performance during aliquoting applications. Set up once, aliquoting only requires a few simple steps thereafter.
Enables aliquoting into 10 Flexsafe® bags simultaneously.
A support to correctly position the air purge solution and the inlet tubing of the Linkit® AX consumable.
Experience a new way of aliquoting.
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The Linkit® AX Single-Use assembly is available with different configurations dependent on process needs.
The main processing unit has a fixed design, however certain options are available to choose from and inlets | outlets can be configured to meet and easily integrate any specific process requirements.
Sartorius offers a range of pre-designed Linkit® AX single-use assemblies. If the standard-to-order designs do not meet the process requirements, our extensive component library in the configure-to-order space or our design experts can tailor solutions to meet them.
150, 250, 500 and 1,000 mL Flexsafe® 2D Bags.
Yes, the Cubis® II Balance keeps 21 CFR part 11 compliant digital batch records that can easily be exported.
10 Flexsafe® bags.
Opta® SFT, AseptiQuik®, ReadyMate, Kleenpak™ HT, Kleenpak™ Presto and plugs on TPE tubes, however if your process requires another type of connection, our design experts are here to assist you.
Linkit® AX single-use assemblies are assembled in ISO 7 certified cleanrooms in accordance with applicable cGMP guidelines. Each system undergoes a variety of in-process quality inspections including 100% visual inspection and 100% leak testing (pressure decay) of the main distribution assembly hub and Flexsafe® bag chambers. To support you in your regulatory needs, specific documentation is available upon request:
In case additional testing is required, you can request your validation study via Confidence® Validation Services.
Benefit from low extractable profiles for both silicone and TPE tubing to transfer critical fluids across process steps.
Quickseal® aseptic disconnectors simplify critical fluid management by making aseptic disconnection fast and secure.
Single-use assemblies are essential in bio-manufacturing processes but their importance can be overlooked.
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