vol.63-4 (2025/11/30)

Evaluation method for cleanroom garment on PIC/S GMP Annex 1

PIC/S GMP Annex 1 is a guideline concerning the manufacture of sterile medicinal products and was implemented in August 2023. It calls for the evaluation and specification of management processes as part of the qualification program for clothing. It also stipulates the specification of the maximum number of washing and sterilization cycles. Taking into account the characteristic of clothing, it is effective to conduct accelerated washing and sterilization cycle tests to determine the expiration date, and to use the tumbling method to measure self-dust generation and the operational dust generation method to measure dust generation during wear. It is also important to verify changes in the appearance of cleanroom clothing during accelerated testing and fabric strength through tear tests.

Implementation of air cleanliness risk assessment testing and its application to PIC/S GMP CCS formulation : Recovery test (PIC/S GMP, ISO-14644-3 Requirements)

With the 2022 revision of PIC/S GMP Annex 1, Japanese pharmaceutical facilities are now required to establish a Contamination Control Strategy (CCS). In response, systematic implementation of air cleanliness risk assessment testing has become increasingly important. Historically, Japan has maintained air cleanliness based on IEST guidelines to meet FDA inspection standards. However, since joining PIC/S, there has been a shift toward EU-style environmental control centered on the ISO-14644 series.
This report presents the results of a Recovery Test conducted in the cleanroom, in accordance with PIC/S GMP and ISO-14644-3 requirements. The aim is to contribute to the development of effective CCS strategies in pharmaceutical manufacturing environments.

Responses and issues arising from the PIC/S Annex 1 revision:
focusing on the contamination control strategy (CCS)

Since August 2023, the revised Annex 1 of PIC/S GMP has been in effect, introducing the concept of a Contamination Control Strategy (CCS) and emphasizing the importance of environmental control in aseptic manufacturing. This article presents an overview of three notable themes related to the revision from the perspective of mechanical and electrical subcontractors: (1) cleanroom recovery testing, (2) quality management of compressed air, and (3) the importance of environmental monitoring in cleanrooms. All of these are closely related to the design, construction, and operation of cleanrooms, and require careful attention in on-site practices.

Technical review of JIS Z 8122 Amendment 1

This technical review provides an overview of “Amendment 1” to JIS Z 8122, which defines terminology for contamination control. With the establishment of ISO 29463 (HEPA/ULPA filters) and ISO 16890 (medium- and coarse-efficiency air filters), together with their domestic counterparts JIS B 9927 and JIS B 9908, the terminology and definitions in the previous JIS Z 8122 had become inconsistent with ISO and JIS standards for air filters, creating a risk of market confusion.
Amendment 1 addresses this by (1) redefining HEPA-related terms on the basis of the Most Penetrating Particle Size (MPPS), defined as the particle diameter at which the penetration is maximum or, equivalently, the collection efficiency is minimum., (2) explicitly distinguishing between fractional (local) collection efficiency and overall collection efficiency, and (3) adding a requirement for scanning leakage tests as a pass/fail criterion for HEPA filters, thereby harmonizing with ISO/JIS for air filters.
As technical background, this technical review explains in detail the mechanical particle collection mechanisms–Brownian diffusion, interception, inertial impaction, and gravitational settling–that give rise to the MPPS, which is the key focus of Amendment 1. Using the derivation of a dimensional approximate theoretical equation for the MPPS, and MPPS measurement data on glass-fiber and PTFE media, it demonstrates that finer fibers shift the MPPS toward smaller particle diameters, whereas lower media filtration velocities shift the MPPS toward larger particle diameters.
Through this amendment, the terminology defined in JIS Z 8122 is now aligned with ISO and JIS standards for air filters; inaccuracies in terminology and definitions are eliminated, and the performance evaluation, classification into efficiency classes, and specification display of HEPA/ULPA filters are clarified. This enables technically accurate citation across many standards and guidelines, including the Standard Specifications for Public Building Construction, the HEAS guidelines for hospital HVAC design and management, and JEM 1467 of the Japan Electrical manufacturers’ Association.

Airflow and wind speed measurement in clean rooms

To maintain air cleanliness within a clean room, it is important to take in clean air and exhaust it with appropriate airflow. There are two types of air intake methods: unidirectional and non-unidirectional. When measuring airflow at the intake port, in unidirectional flow method, the uniformity of the airflow is important, while in non-unidirectional method, the intake flow rate is important. Furthermore, it is necessary to use a method that can suppress the effects of local flow velocity variations and ensure reproducibility through repeated measurements. In other locations, it is important to ensure that there is no stagnation in the airflow. Visualization using tufts or tracers is an effective way to confirm the air flow status.