vol.64-1 (2026/5/31)

Human resource development initiatives at the Tokyo University of Science GMP course

Pharmaceuticals must be strictly managed in accordance with the Pharmaceuticals and Medical Devices Act, and the GMP Ministerial Ordinance, since the quality, efficacy, and safety of pharmaceuticals cannot be determined from their appearance.
Recent scandals, however, have highlighted issues such as the lack of systems in place, awareness of compliance with laws and regulations, and the absence of a strong quality culture. The three universities have collaborated to create a unified GMP training course based on the EU QP system, and are promoting practical human resource development, in order to ensure stable supplies and strengthen responses to infectious disease emergencies.

Initiative toward General Course of Cleanroom Technology Professionals and General Course of Cleanroom Tests

The International Confederation of Contamination Control Societies (ICCCS) Education Committee (IEC) promotes the preparation and accreditation of internationally-recognised educational courses for people who design, test, operate, and work as operators in cleanrooms. ICCCS member societies should develop courses of a high standard, and this should be achieved through an accreditation process. Each course would be accredited through a submission to the IEC that would provide information about the course and demonstrate that it conforms to a set of accreditation guidelines. Japan Air Cleaning Association, that is a member committee of the ICCCS has established the Board for Accreditation of Cleanroom Technology Professionals to develop the relevant courses, and prepare and submit the accreditation submission to the IEC in 2020. Currently, the JACA has two internationally-recognised educational courses (General Course of Cleanroom Technology Professionals and General Course of Cleanroom Tests). This article reports the circumstances and histories concerning the Board for Accreditation and the relevant educational courses.

A proposal for a safe and simple leak testing method for HEPA Filters installed on site

In pharmaceutical manufacturing facilities, leak testing of HEPA filters is required to be conducted as part of periodic validation in accordance with Good Manufacturing Practice (GMP). In conventional testing methods, the HEPA filter cover is removed during measurement to perform the leak test; however, it has been reported that there is a risk of damaging the filter itself during this operation or during scanning.
To reduce this risk, we investigated a method that enables manual leak testing to be performed without removing the HEPA filter cover. First, as a measure to prevent contamination during operation, a magnetically attached contamination prevention sheet was mounted on the punching cover and a leak test was conducted. Compared with the conventional method, this approach allowed the leak test to be performed more safely and reliably.
Next, instead of using the contamination prevention sheet, we evaluated a method in which a measurement eyelet was directly attached to the filter cover. As a result, it was found that the use of a punching cover equipped with an eyelet is applicable as a safe and simple leak testing method.

“GMP Visualizer” and its extension “AC-Plus”

“GMP Visualizer” is a layout planning tool developed using Grasshopper to develop or study initial rough layouts of pharmaceutical facilities. The generated layout is a 3D model, and each room contains the following data and information, such as room name, room area, room height, and cleanliness grade. Initial HVAC system planning can be easily facilitated using this information. In this report, “GMP Visualizer” and its developed extension, “AC-Plus,” are introduced as an automatic calculation system for supporting the design of pharmaceutical facilities’ HVAC systems.

Development of a cleanliness and dew point measurement robot for construction site automation

In construction projects for cleanrooms and clean-dry rooms, environmental measurements such as cleanliness and dew point temperature are essential for quality assurance prior to handover. However, conventional manual measurements require substantial labor for multi-point sampling and report preparation, and operator movement can affect measurement stability due to particle resuspension. To address these issues, we developed an autonomous robot system capable of performing multi-point measurements of cleanliness, dew point temperature, and temperature and humidity, while automatically storing and processing data for rapid report generation. The system integrates autonomous navigation with obstacle avoidance, a sensor box designed for measurements at approximately 1.0-1.5 m above the floor, onboard data storage in a database on the measurement PC, and a workflow that supports CSV export and report generation. Field trials conducted in a large-scale clean-dry room (approximately 100 m × 100 m) demonstrated stable autonomous operation and significant labor reduction compared with manual measurements. In a representative case, the robot completed measurements at 267 points in approximately 6 hours and 45 minutes, reducing the total workload from 9-11 person-days to 2 person-days. These results indicate that the proposed system improves both operational efficiency and measurement quality by standardizing procedures and minimizing human influence. Remaining challenges include further improving positioning accuracy, reducing setup time, enhancing usability for on-site personnel, and strengthening safety functions such as detection of floor openings and dynamic obstacles.

Improvement approaches for field commissioning of airflow and pressure

This paper reports on our efforts to enhance commissioning capabilities for biological cleanrooms (BCR). BCR commissioning requires appropriate adjustments based on room configuration and local exhaust system operation patterns, demanding high technical expertise. Two key challenges were identified: the complexity of pre-construction planning and the limitations of conventional training methods. To address the first challenge, we developed a dynamic pressure simulator as a commissioning support tool. By enabling pre-construction examination of damper openings, control parameters, and system startup/shutdown sequences, the simulator has contributed to significant improvements in time efficiency and reduction of on-site trial iterations. Regarding the second challenge, conventional education methods such as theoretical learning and on-the-job training (OJT) have limitations in providing hands-on experience due to safety constraints at actual sites. To overcome this, we constructed a mock-up facility capable of reproducing various BCR air-conditioning systems and developed a structured three-day, 14-hour training program. The program progresses systematically from basic adjustment procedures to advanced risk response exercises, accommodating participants with diverse skill levels. The program has been conducted since 2024 and has received positive feedback.

Energy saving in data centers

With the social implementation of AI, the construction of data centers (hereinafter, DCs) is expected to increase further in the future. Along with this, challenges such as power shortages due to increased electricity demand, decarbonization, and operational costs need to be addressed. Against this background, initiatives for ‘Watt-Bit Collaboration,’ which aim to link power infrastructure (watts) with information and communication infrastructure (DCs, networks, bits) to simultaneously solve the rapidly increasing DC demand and power constraints, are being advanced. In addition, the Agency for Natural Resources and Energy is instructing that existing DCs maintain a PUE of 1.4 or lower. This paper presents measures at the operational stage, focusing on energy savings for air-conditioning and cooling systems, which account for the majority of the energy consumed by data centers.