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  5. A New International Standard for Aseptic Processing of Health Care Products — Isolator Systems

A New International Standard for Aseptic Processing of Health Care Products — Isolator Systems

Providing the best possible manufacturing environment for cutting-edge pharmaceuticals

June 8, 2021

The International Organization for Standardization (ISO) has issued an international standard for "Aseptic processing of health care products — Isolator systems" that have been revised based on a proposal from Japan. This international standard introduce the concept of "aseptic connection" for the isolator systems necessary for manufacturing pharmaceuticals in an aseptic environment, and cover the basic principles, design, validation, and operation. The international standard is expected to be used in manufacturing and controlling pharmaceutical manufacturing facilities, thereby significantly improving the manufacturing environment for pharmaceuticals and providing stable, high-quality pharmaceutical products.

1. Background

Pharmaceuticals injected into patients' bodies are required to be sterile and free from bacterial contamination. In particular, cutting-edge pharmaceuticals and vaccines cannot be sterilized (that is, killing bacteria, etc.) by heat, so they need to be produced in an aseptic production environment that prevents bacterial contamination.
At pharmaceutical manufacturing sites, isolator systems (devices that enclose production equipment in a sealed space and provide an aseptic environment free from bacteria) have been used in production lines as equipment for building an aseptic environment. These facilities have been well suited for use in mass production. However, the production of pharmaceuticals for individual medical care (such as cutting-edge regenerative medicine applications) requires different pharmaceutical products to be manufactured for each patient. Conventional facilities have been too inflexible to meet the need for individual medical care —requiring switching facilities for each drug, for instance. Against this background, Japan proposed a revision of the international standard for "isolator systems with aseptic connection interfaces" that will enable aseptic spaces to be connected, and thereby make it possible to operate isolator systems flexibly.

2. Outline of the international standard

The international standard ISO13408-6 (Aseptic processing of health care products — Isolator systems)*1 specify the requirements for the use of isolator systems in the manufacture of health care products (pharmaceuticals and medical devices) using aseptic processing (mainly aimed at products that cannot be sterilized). The main topics covered are as follows:

This international standard is based on the "R&D Guidelines for the Design of an Aseptic Transfer Interface 2012" developed by the Project to Develop Guidelines for Medical Devices, Etc.*2 led by the Ministry of Economy, Trade and Industry (METI). As the project leader, Japan led the revision of the international standard and submitted a proposal to ISO/TC 198 (Sterilization of healthcare products)/WG 9 (Aseptic processing) in December 2016. For the next four and a half years or so, discussions were held and adjustments made continually, mainly by members of an international review committee consisting of universities, research institutes, device manufacturers, etc. As a result, the international standard is published on April 13, 2021. *3

3. Expected effects

Utilizing this international standard in the manufacturing control of pharmaceutical manufacturing facilities will spread the concept of "aseptic connections" that enable devices based on isolator systems to be separated and joined aseptically and freely. The resulting widespread use of interfaces that enable aseptic connections will drive further development of systems (flexible modular platforms) that enable the users to freely connect and disconnect various state-of-the-art pharmaceutical manufacturing equipment while maintaining a aseptic manufacturing environment. This is expected to significantly improve the manufacturing environment of pharmaceuticals and provide a stable supply of high-quality pharmaceutical products.

Figure 2: Alliance of device companies in Japan that can be connected and disconnected by aseptic connections

*1: Official name
ISO 13408-6: Aseptic processing of health care products — Part 6: Isolator system

*2 Project to Develop Guidelines for Medical Devices, etc.
In collaboration with the Ministry of Health, Labour and Welfare, METI has formulated development guidelines to speed up the review process for approval required under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The aim is to achieve rapid commercialization of innovative medical devices, etc.

*3 The international standard issued this time is the result of the "Strategic International Standardization Acceleration Project: International Standards Development Activities in the Government's Strategy Fields," a project commissioned by METI.

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