Automated Aliquoting System (AAS)
Automated Aliquoting for Critical Single-Use Workflows
Dispensing bulk drug substance or intermediate product into smaller single-use containers through manual aliquoting remains one of the most operator-dependent steps in biopharmaceutical manufacturing. Every valve turn, weight check, and container swap is a chance for variability to enter the batch record. Meissner’s Automated Aliquoting System (AAS) standardizes this step to deliver 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 Does
The Automated Aliquoting System automates the transfer of bulk product into final single-use containers, whether bottles, bioprocessing bags, 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 TepoFlex® biocontainer assemblies, FlexFill® transfer assemblies, M-Sil™ silicone and M-Flex® TPE tubing and tubing assemblies, and UltraClamp® sanitary clamp connections
Supporting Annex 1’s contamination control expectations
Annex 1 does not name aliquoting as a discrete operation. It does define the operations aliquoting comprises: aseptic compounding and mixing, replenishment of sterile bulk, and handling of open containers. These are all Grade A activities (Table 4; cl. 8.20). The expectations that apply to those operations apply to aliquoting.
Annex 1 does set a clear priority: design risk out first; minimize direct intervention into Grade A by design; and use robotics and automation to eliminate direct human critical interventions (cl. 2.2, 4.4, 8.9).
The AAS puts the control at the design level. It removes the operator from the critical zone at the point of product exposure, replaces variable manual technique with a repeatable automated sequence, and reduces the number of operator interventions that must be qualified and justified through APS (cl. 8.16). The records it generates feed the batch record and the site Contamination Control Strategy (cl. 8.17, 2.3).
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 Automated Aliquoting System (AAS)?
The AAS is a system that automates aseptic filling in biopharma manufacturing operations, consistently and repeatably. This system can be used for aliquoting in upstream and downstream applications, including media and buffer, and final product, using single-use closed systems.
Is automation for aliquoting required?
No, automation is not required according to regulatory guidelines such as EU Annex 1, but it is encouraged to minimize operator error and ensure accuracy of batch records and complete documentation.
Is the AAS customizable for my needs?
Yes, the AAS is easily configured to handle aseptic transfer into final single-use containers such as bottles, biocontainers, or any final primary packaging format, in a repeatable process.
How does the AAS handle documentation?
The AAS provides 21 CFR Part 11 compliant software for batch records and secure audit trails linked to each customer’s Supervisory Control and Data Acquisition (SCADA) system, ensuring accuracy and traceability.
What single-use systems can be used with the AAS?
Meissner has a comprehensive array of Single-Use System (SUS) assemblies that have been qualified and optimized for use with the AAS, including TepoFlex® single-use biocontainer bags and sampler containers, FlexFill® transfer assemblies, M-Sil™ tubing, CryoVault® Freeze and Thaw rigid containers, and UltraClamp® connectors.
How big is the AAS?
The AAS is highly compact, measuring only 5.91 ft (1.8 m) tall, 4.95 ft (1.51 m) wide, and 2.72 ft (0.83 m) deep, inclusive of caster wheels for easy mobility. Addition of carts for each separate fill will measure 5.91 ft (1.8 m) tall, 3.32 ft (1.01 m) wide, and 2.76 ft (0.84 m) in depth.
