Automated Aliquoting System (AAS)
Automated Aliquoting for Critical Single-Use Workflows
The Automated Aliquoting System (AAS) standardizes the transfer of bulk product into final single-use containers through automated, recipe-driven execution. Designed for biopharmaceutical manufacturing, the AAS delivers consistent fill accuracy, enhanced process control, and digital batch documentation across critical aliquoting operations.
The challenge with manual aliquoting
Manual aliquoting introduces the same categories of risk regulators have flagged across aseptic processing generally: inconsistent technique between operators, extended intervention time in classified areas, and a training burden that scales with every new product or container format. As batch counts and product variety increase, manual aliquoting becomes a bottleneck as well as a risk.
What the AAS Delivers
The Automated Aliquoting System automates the transfer of bulk product into final single-use containers, whether bottles, biocontainers, or other primary packaging formats, replacing manual weighing, valve operation, and container handling with a repeatable, recipe-driven process and accurate batch records. The results are consistent, precision filling across operators, shifts, and batch sizes to support contamination control and operational efficiencies.
Key benefits
- • Consistent fill accuracy across batches, operators, and shifts
- • Automated, recipe-driven workflow execution
- • Enhanced process control and operational efficiency
- • Rapid changeovers between container formats and batch sizes
- • Electronic records supporting data integrity, traceability, and review-by-exception workflows
- • Seamless integration with Meissner single-use technologies, including single-use biocontainer assemblies, FlexFill® transfer assemblies, M-Sil™ silicone and M-Flex® TPE tubing assemblies
Supporting Annex 1’s contamination control expectations
While EU GMP Annex 1 does not name aliquoting specifically, its core principles apply directly to minimizing direct human intervention in Grade A operations, maintaining a documented Contamination Control Strategy (CCS) across every critical step. Using automation and robotics where they can remove operator-dependent risk, the AAS is designed around those same principles, extending the standardization and control Annex 1 already expects for PUPSIT and filtration to the aliquoting step as well.
Built on Meissner’s single-use systems expertise
The AAS works seamlessly with Meissner’s standard single-use systems portfolio with customizations available to ensure optimization of the supporting fluid path.
Frequently Asked Questions
What is the AAS?
The AAS is a machine that automatically fills biocontainers with liquid medicine ingredients (a process called aliquoting), in sizes from 1 to 20 liters. It uses precise monitoring technology to do this without a human operator, which also keeps more accurate and complete records.
Do I have to automate this process?
No, it’s not required by regulations like EU Annex 1. But it is encouraged, since it reduces human error and improves the accuracy of your records.
Can the AAS be customized for my needs?
Yes. It can be set up to fill different types of final containers, such as bottles or biocontainer bags, in a consistent, repeatable way. Meissner offers both standard and customizable single-use assemblies to fit your needs.
How does the AAS handle records and documentation?
It uses secure, FDA-compliant software (21 CFR Part 11) to create and store batch records and audit trails, keeping everything accurate and traceable.
What parts and containers work with the AAS?
The AAS works with several Meissner products, including TepoFlex® single-use bags and sample containers, FlexFill® transfer assemblies, M-Sil™ tubing, CryoVault® freeze-and-thaw containers, and UltraClamp™ connectors.
What are the dimensions of the AAS?
It’s compact and easy to move. It’s approximately 5.9 feet (1.8 m) tall, 5 feet (1.52 m) wide, and 2.7 feet (0.82 m) deep, including wheels. If you add carts for separate fills, each cart is about 5.9 feet (1.8 m) tall, 3.3 feet (1.01 m) wide, and 2.75 feet (0.84 m) deep.
