HPLC (Advanced Clinical Laboratory) for Quality Control: Automated Pre-analytical Preparation System Launched for Practical Application
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May 20, 2026
ROHTO Pharmaceutical Co., Ltd. (Headquarters: Osaka City, Osaka Prefecture; President and Representative Director: Hidetoshi Segi) has collaborated with Aligntec Co., Ltd. (Headquarters: Iwakuni City, Yamaguchi Prefecture; President and Representative Director: Fumio Ueda) to develop an automated HPLC (liquid chromatography) analysis pretreatment system. This system aims to achieve the high quality control required for pharmaceuticals and other products, and to address the shortage of engineers due to the declining workforce and changes in work styles. Operational testing for practical use has begun at the Rohto Group Quality Inspection Center (Ibaraki City, Osaka Prefecture). Moving forward, we will continue our efforts to stably deliver high-quality products to our customers by strengthening our quality assurance system.
*HPLC (liquid chromatography) is an analytical technique that uses a liquid as the mobile phase and utilizes the differences in interaction with the packing material in the column to separate and quantify components in a mixture with high precision and speed. Liquid chromatography is an important quality control analytical method used to measure the amount of active ingredients contained in manufactured products and to confirm whether they are formulated according to specifications.
Automated HPLC analytical sample preparation system (Rohto Group Quality Inspection Center, Ibaraki City, Osaka Prefecture)
Background
Amidst the growing social challenge of labor shortages due to the declining birthrate, our company has embarked on the development of an automated HPLC analytical sample preparation system with the aim of creating an environment where people can focus on more advanced and value-added tasks that are difficult for robots to replace, such as "thinking" and "creating new value," while continuing to provide high-quality products stably.
Furthermore, to meet the diverse needs of our customers, we produce a wide range of products in small quantities and with a high variety of designs. Therefore, in developing this device, we also placed great importance on creating equipment that could flexibly handle a variety of products and test conditions.
In recent years, the importance of quality control has been strongly recognized in the pharmaceutical industry. In testing operations, the means of confirming that work was performed properly have traditionally relied on paper and electronic records, and there have been challenges in objectively demonstrating the actual work procedures and operating conditions.
Given this background, we believe that enhancing the reliability and transparency of the testing process itself will lead to ensuring the quality of pharmaceuticals. By automating a series of operations in HPLC pretreatment, we aim to standardize procedures, improve traceability (a system that allows tracking and recording of all processes), reduce human error, and thereby improve the reliability of test results.
About automated HPLC analytical sample preparation equipment
While automated HPLC sample preparation systems are generally manufactured to handle only specific processes and product types, this system is a fully automated device that can handle small quantities of a wide variety of samples and allows for continuous, scheduled operation of various analytical methods.
Once the device is started, it automatically manages samples, glass containers, and solvents in a central storage unit, eliminating the need for human intervention until the work is completed. From sample preparation to vial filling before HPLC analysis, everything is performed automatically.
Furthermore, traceability is ensured through the management of samples, instruments, and solvents using QR codes, and operation history based on access permissions and records of processing standards and samples according to master settings are saved. In addition, images of alignment of volumetric pipettes and volumetric flasks are saved to support audit trails.
In addition, the design incorporates a one-way use system to reduce the risk of contamination.
The introduction of this device enables standardized test procedures regardless of the technician's skill level, contributing to the creation of a quality control system that is less dependent on the skills of experienced personnel, as well as reducing the time required for training on test procedures.
Aligning the mark on a volumetric flask (to the desired volume)
The robotic arm overturns and mixes, dissolving the contents of the sample.
Device introduction video
You can view the overall configuration of this device and how it operates automatically.
Future outlook
We will proceed with operational verification of the automated HPLC analytical sample preparation system at the Rohto Group Quality Inspection Center. By advancing practical implementation, we aim to expand the environment in which engineers can concentrate more on "creating new value" while continuing to provide high-quality products stably, and to further enhance confidence in quality by improving the reliability and transparency of the testing process.