Single use aliquoting systems | Meissner Corporation

Single-Use Automation Automated Aliquoting Automated Filtration/PUPSIT

Automated Aliquoting System (AAS)

Standardized, Automated Aliquoting for Critical Single-Use Workflows

Manual aliquoting (dispensing bulk drug substance or intermediate product into smaller single-use containers) 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 ensure consistency and accuracy are properly logged.

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 AAS does

Our Automated Aliquoting System (AAS) 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. AAS is optimized for direct integration with Meissner’s range of single-use containers, eliminating operator error and potential contamination points while providing accurate batch records.

Supporting Annex 1’s contamination control expectations

Designed in line with the core principles outlined in EU GMP Annex 1, minimizing direct human intervention, supporting a documented Contamination Control Strategy (CCS) across every critical step, and using automation and robotics where they can remove operator-dependent risk, AAS extends the standardization and control Annex 1 already expects for PUPSIT and filtration to the aliquoting step as well.

Key benefits

• Consistent fill accuracy across operators, shifts, and batches
• Ease of use reduces operator-induced variability and intervention in classified (Grade A/B) areas
• Time-savings for faster changeover between container formats and batch sizes
• Scalable compatibility with Meissner’s existing single-use fluid path, including Meissner’s One Touch^® TepoFlex^® biocontainers, FlexFill^® transfer assemblies, CryoVault^® Freeze and Thaw containers, M-Sil^™ tubing, and UltraClamp^® connections
• Accurate 21 CRF Part 11 data trails and electronic records

Built on Meissner’s single-use systems expertise

The AAS is designed to integrate directly with Meissner’s existing single-use portfolio, so standardizing aliquoting doesn’t mean redesigning the fluid path around it.