News&Insight

Continued investment in essential scientific instruments brings risk management to the source of R&D and manufacturing.

Atlas Link Technology has completed a comprehensive upgrade of all manual pipettes used across its R&D and production departments, introducing the new-generation Eppendorf Research^® 3 neo pipettes throughout these operations.

The upgrade spans product design and development, raw-material evaluation, formulation screening, process development, preparation of critical solutions, production process control, performance verification and quality control testing. This is more than an equipment update. It is an upstream quality initiative intended to strengthen the reliability of R&D data, the stability of manufacturing processes and lot-to-lot consistency.

More Than Six Decades of Micropipetting Technology

Pipettes are precision instruments used in laboratories to accurately aspirate and transfer small volumes of liquid. Modern piston-operated micropipetting technology emerged in the late 1950s. In 1961, Eppendorf helped advance its industrial production and commercialization, supporting greater accuracy and standardization in small-volume liquid handling.

Introduced by Eppendorf in 2025, the Research 3 neo is a new-generation mechanical pipette featuring a volume lock, four-digit volume display, fast/fine volume adjustment and spring-loaded tip cone, together with further improvements in handling and ergonomics.The ergonomic design can reduce the physical burden associated with frequent pipetting and may help control operator variation associated with fatigue.The pipettes also support cleaning, decontamination and autoclaving under specified conditions, providing a stronger equipment foundation for laboratory hygiene and contamination control.

Risk Management Starts with Essential Instruments

In IVD development and manufacturing, a pipetting step may appear routine, yet pipettes are directly involved in the quantitative handling of antigens, antibodies, conjugates, control materials and critical solutions. Even a minor volume deviation may affect solution concentrations, experimental data and the consistency of downstream manufacturing processes.

Following its analysis, the Atlas Link Technology risk management team determined that potential variation may arise not only from the instrument itself, but also from differences between devices, calibration drift over time, tip compatibility, unintended volume settings and differences in operator technique. Such deviations may not be immediately apparent and may be carried forward through subsequent process steps.

ISO 13485 requires controlled management of processes and monitoring and measuring equipment that can affect product quality, while ISO 14971 requires manufacturers to identify and control product-related risks that may affect medical device safety and performance. Controlling the equipment, methods and operators involved in critical pipetting steps forms part of applying these principles in R&D and manufacturing.

Persistent attention to risks at their source is part of the Atlas Link Technology quality culture. The company continues to invest in essential scientific instruments not simply to pursue premium brands or equipment specifications, but to reduce foreseeable uncertainty and control potential variation before it affects R&D data or manufacturing processes.

Turning Advanced Equipment into Process Capability

High-performance equipment provides an important foundation for risk control, but procurement and deployment alone do not automatically eliminate risk.

All new pipettes have been incorporated into the Atlas Link Technology quality management system, with standardized requirements for equipment identification, acceptance verification, operator training, calibration checks, cleaning, maintenance and the traceability of abnormalities. Pipette-and-tip combinations, operator techniques and methods for pipetting liquids with special physical properties are also managed under standardized requirements.

If a pipette is dropped, leaks, malfunctions or is found to be outside the specified calibration limits, it will be removed from service immediately and returned to use only after inspection, any necessary maintenance or recalibration, and documented confirmation of acceptability. An impact assessment will then be conducted for any potentially affected R&D studies, production lots or test results. Calibration, maintenance and usage data will also be reviewed over time to confirm that the relevant risk controls remain effective.Through this approach, instrument performance can be translated into a controlled, verifiable and traceable foundation for pipetting operations.

Building Product Consistency One Microliter at a Time

A pipette alone does not determine the sensitivity, specificity or shelf life of an IVD product. However, accurate, stable and controlled pipetting is an important foundation for reliable R&D data and stable manufacturing processes.

Following standardized calibration, verification, training and maintenance, the upgraded pipette setup can help control some sources of variation associated with equipment and operating conditions, providing an equipment and management foundation for repeatable solution preparation and dispensing and for maintaining within-lot and lot-to-lot consistency.

Simply put, this upgrade does not claim that a pipette can change product performance on its own. It addresses unnecessary variability at each fundamental step, making R&D data more comparable, manufacturing processes more stable and quality results more traceable.