Rohto Pharmaceutical Launches Operational Testing for HPLC Analysis Pre-processing Automation System
Rohto Pharmaceutical, in collaboration with AlignTech, has developed an automated HPLC analysis pre-processing system and commenced operational testing at its Rohto Group Quality Inspection Center. The initiative aims to enhance pharmaceutical quality control, address labor shortages, and ensure traceability for small-lot, high-variety production.
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- 📰 Published: May 20, 2026 at 19:00
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Rohto Pharmaceutical Co., Ltd., in collaboration with AlignTech Co., Ltd., has developed an automated system for HPLC (High-Performance Liquid Chromatography) analysis pre-processing to achieve the high level of quality control required for pharmaceuticals and to address labor shortages caused by a shrinking workforce. Operational testing for commercialization has begun at the Rohto Group Quality Inspection Center (Ibaraki City, Osaka Prefecture). The company remains committed to strengthening its quality assurance systems to consistently deliver high-quality products to customers.
Background
Amidst social challenges like the shrinking workforce, Rohto developed this system to maintain stable delivery of high-quality products while creating an environment where employees can focus on higher-value tasks—such as creative problem solving—that are difficult for robots to replicate. Given the company's commitment to small-lot, high-variety production to meet diverse customer needs, the system was designed to be highly flexible for various products and testing conditions.
Recently, the importance of quality control in the pharmaceutical industry has been strongly reaffirmed. Traditional verification of test procedures relied primarily on paper or electronic records, which often lacked objective evidence of actual operational steps. To address this, Rohto believes that increasing the reliability and transparency of the testing process itself is key to ensuring pharmaceutical quality. By automating the HPLC pre-processing chain, the company aims to standardize procedures, improve traceability, reduce human error, and enhance the reliability of test results.
About the HPLC Analysis Pre-processing Automation System
Unlike many automated systems that are limited to specific processes or items, this system is a fully automated unit capable of handling small-lot, high-variety samples and executing diverse analysis methods via continuous scheduled operation.
Once started, the system manages samples, glassware, and solvents via an integrated stocker and automatically completes all tasks from pre-processing to vial filling, requiring no human intervention. Traceability is ensured through QR code management of samples, tools, and solvents. It saves operation logs based on access permissions and records proving that standards and samples were processed under specified conditions and volumes. Furthermore, by capturing images of liquid level alignment for pipettes and volumetric flasks, the system complies with audit trail requirements. Additionally, the design uses disposable tools to mitigate contamination risks. This implementation enables standardized test operations regardless of technician skill levels, supporting a quality control system less reliant on individual expertise and contributing to reduced training time.
Future Outlook
Rohto will continue operational testing at its Quality Inspection Center. Through commercialization, the company aims to expand an environment where technicians can focus on creating new value while maintaining stable delivery of high-quality products, ultimately increasing trust in pharmaceutical quality through improved testing process reliability and transparency.
Background
Amidst social challenges like the shrinking workforce, Rohto developed this system to maintain stable delivery of high-quality products while creating an environment where employees can focus on higher-value tasks—such as creative problem solving—that are difficult for robots to replicate. Given the company's commitment to small-lot, high-variety production to meet diverse customer needs, the system was designed to be highly flexible for various products and testing conditions.
Recently, the importance of quality control in the pharmaceutical industry has been strongly reaffirmed. Traditional verification of test procedures relied primarily on paper or electronic records, which often lacked objective evidence of actual operational steps. To address this, Rohto believes that increasing the reliability and transparency of the testing process itself is key to ensuring pharmaceutical quality. By automating the HPLC pre-processing chain, the company aims to standardize procedures, improve traceability, reduce human error, and enhance the reliability of test results.
About the HPLC Analysis Pre-processing Automation System
Unlike many automated systems that are limited to specific processes or items, this system is a fully automated unit capable of handling small-lot, high-variety samples and executing diverse analysis methods via continuous scheduled operation.
Once started, the system manages samples, glassware, and solvents via an integrated stocker and automatically completes all tasks from pre-processing to vial filling, requiring no human intervention. Traceability is ensured through QR code management of samples, tools, and solvents. It saves operation logs based on access permissions and records proving that standards and samples were processed under specified conditions and volumes. Furthermore, by capturing images of liquid level alignment for pipettes and volumetric flasks, the system complies with audit trail requirements. Additionally, the design uses disposable tools to mitigate contamination risks. This implementation enables standardized test operations regardless of technician skill levels, supporting a quality control system less reliant on individual expertise and contributing to reduced training time.
Future Outlook
Rohto will continue operational testing at its Quality Inspection Center. Through commercialization, the company aims to expand an environment where technicians can focus on creating new value while maintaining stable delivery of high-quality products, ultimately increasing trust in pharmaceutical quality through improved testing process reliability and transparency.
FAQ
What is Rohto's HPLC automation system?
It is an automated testing system that performs sample preparation through pre-analysis setup for small-lot, high-variety products without human intervention, ensuring traceability.
What quality control challenges does this system solve?
It standardizes work procedures, improves traceability, reduces human error, and enhances the reliability and transparency of test results.
Why is automation necessary?
To address labor shortages and allow skilled technicians to focus on higher-value tasks, such as creative work.