vol.63-1 (2025/5/31)

Type certification of class II biological safety cabinet by JACA No.48-2021

Class II Biological Safety Cabinets are used as the primary barrier to protect users from biohazards. Currently, the responsibility for inspecting cabinets for conformance to standards is left to the outgoing inspection under the manufacturer’s responsibility. However, in order to ensure the performance of the cabinets supplied by each manufacturer, including equipment specifications, it is extremely important that a third-party organization verify and certify the cabinets according to JACA No48-2021. For this purpose, Japan Air Cleaning Association (JACA) implements this system with the aim of protecting users and the environment from biological hazards by inspecting the suitability of cabinets, providing type certification, and ensuring that the performance of cabinets supplied by each manufacturer exceeds a certain standard. Nippon Medical & Chemical Instruments Co. Ltd has developed a new cabinet and has received JACA type certification, we will introduce the details here.

Training seminars for In-Place Certification Technician of Class II Biological Safety Cabinets

Class II biological safety cabinets are equipped with excellent mechanisms that can prevent contamination of both (1) operators and the environments in which cabinets are installed, and (2) the work target (sample). However, because of their excellent mechanisms, their performance cannot be fully demonstrated unless proper operation and management are carried out. Therefore, Japan Air Cleaning Association holds seminars to train technicians who will install the cabinets and carry out periodic inspections. This article introduces these seminars.

Japan International Cooperation Agency’s activities towards infectious diseases control (Case of the Democratic Republic of the Congo)

Japan International Cooperation Agency (JICA), an incorporated administrative agency in charge of administering Japan’s Official Development Assistance (ODA), is one of the world’s largest bilateral aid agencies supporting socioeconomic development in developing countries in different regions of the world.
This article introduces JICA and its initiatives to enhance infectious disease control and testing capacities, with a particular focus on activities in the Democratic Republic of the Congo (DRC). During a JICA training session held in Japan for DRC participants, the JACA Guideline No.17, titled “Field Inspection Manual for Class II Cabinets for Biohazard Control, 2nd Edition,” was translated into French and utilized as a key resource. This translation and application of the guideline played a crucial role in instructing participants on effective inspection practices for biological safety cabinets.

The role and differences between NSF and JIS standards for Class II biosafety cabinets

Class II Biological Safety Cabinets (BSCs) are laboratory equipment designed to contain biohazards. They are primarily used in hospital laboratories, infectious disease laboratories, and university laboratories when handling pathogens and genetically modified organisms. The primary purpose of BSCs is to protect researchers from exposure to infectious agents and to prevent the release of potentially harmful engineered organisms. Therefore, they must be designed in accordance with strict safety standards. Typical standards for BSCs include the NSF/ANSI 49 standard (USA), the EN 12469 standard (Europe), and the JIS K 3800 standard (Japan).
This article focuses on the NSF standard, comparing it with the JIS standard in terms of their development history, required performance criteria, and evaluation methods. The differences between these standards and their implications for the design and operation of Class II BSCs are discussed. The specific characteristics of the JIS standard and related challenges are also examined.

Measuring with “aerosol photometer” and “airborne particle counter”

In order to secure cleanliness of biological safety cabinet, leaking test of HEPA/ULPA filter is one of the critical and essential processes. Air recirculating through the HEPA/ULPA filter, it captures and removes some toxic and hazardous viruses and bacteria. Therefore, we need to check filter has no leakage before carrying on operation in the biological safety cabinet. Challenging HEPA/ULPA filter with aerosol photometer or airborne particle counter as measurement equipment are both correct options according to ISO 14644-3 but the aerosol photometer is preferred measurement equipment for leaking test of HEPA/ULPA filter. Character of the airborne particle counter is designed for certifying cleanroom, monitoring and counting number of different size of particles. Depends on testing method and purpose for carrying out, it is very important to choose preferred equipment.

HVAC system qualification of pharmaceutical facilities

Heating, Ventilation, and air conditioning (HVAC) systems can critically affect the ability of pharmaceutical facilities, which must ensure the quality and safety of pharmaceutical products. In many cases, the design of these systems must comply with Good Manufacturing Practice (GMP) and its trends. To plan and conduct HVAC qualification, it is essential for suppliers to acquire basic knowledge of HVAC qualification. This paper shows the purpose and verification methods of qualification particularly IQ/OQ, for HVAC systems from the supplier’s perspective.

Basics of performance evaluation in cleanrooms

When a cleanroom is handed over after completion and when it is operated and maintained, it is necessary to measure, evaluate, and quantify various performances of the cleanroom. This lecture summarizes the basics of measurement and performance evaluation tests in cleanrooms. There are a wide variety of items to be tested in cleanrooms, and JIS and ISO have various standards corresponding to them. This lecture first summarizes the standards related to cleanroom performance tests in JIS and ISO. Before performing the test, it is necessary to select the items to be measured, plan the implementation procedure and specific implementation method, and prepare measuring instruments. The items to be tested vary greatly depending on the purpose of the test, the use, size, and structure of the cleanroom. This lecture summarizes the purpose of performance evaluation tests in cleanrooms, and provides an overview of the approach to selecting test items and points to note when performing the test. In addition, test items that are considered important other than those covered in this course are also explained.