ISO 14644-1:2015(EN)

Foreword

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The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.

This second edition cancels and replaces the first edition (ISO 14644-1:1999), which has been technically revised throughout.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:

•  Part 1: Classification of air cleanliness by particle concentration

•  Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

•  Part 3: Test methods

•  Part 4: Design, construction and start-up

•  Part 5: Operations

•  Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

•  Part 8: Classification of air cleanliness by chemical concentration (ACC)

•  Part 9: Classification of surface cleanliness by particle concentration

•  Part 10: Classification of surface cleanliness by chemical concentration

Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Biocontamination control:

•  Part 1: General principles and methods

•  Part 2: Evaluation and interpretation of biocontamination data

Introduction

Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be beneficial for protection of product or process integrity in applications in industries such as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food.

This part of ISO 14644 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume. It also specifies the standard method of testing to determine cleanliness class, including selection of sampling locations.

This edition is the result of a response to an ISO Systematic Review and includes changes in response to user and expert feedback validated by international enquiry. The title has been revised to “Classification of air cleanliness by particle concentration” to be consistent with other parts of ISO 14644. The nine ISO cleanliness classes are retained with minor revisions. Table 1 defines the particle concentration at various particle sizes for the nine integer classes. Table E.1 defines the maximum particle concentration at various particle sizes for intermediate classes. The use of these tables ensures better definition of the appropriate particle-size ranges for the different classes. This part of ISO 14644 retains the macroparticle descriptor concept; however, consideration of nano-scale particles (formerly defined as ultrafine particles) will be addressed in a separate standard.

The most significant change is the adoption of a more consistent statistical approach to the selection and the number of sampling locations; and the evaluation of the data collected. The statistical model is based on adaptation of the hypergeometric sampling model technique, where samples are drawn randomly without replacement from a finite population. The new approach allows each location to be treated independently with at least a 95 % level of confidence that at least 90 % of the cleanroom or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness. No assumptions are made regarding the distribution of the actual particle counts over the area of the cleanroom or clean zone; while in ISO 14644-1:1999 an underlying assumption was that the particle counts follow the same normal distribution across the room, this assumption has now been discarded to allow the sampling to be used in rooms where the particle counts vary in a more complex manner. In the process of revision it has been recognized that the 95 % UCL was neither appropriate nor was applied consistently in ISO 14644-1:1999. The minimum number of sampling locations required has been changed, compared with ISO 14644-1:1999. A reference table, Table A.1, is provided to define the minimum number of sampling locations required based on a practical adaptation of the sampling model technique. An assumption is made that the area immediately surrounding each sampling location has a homogeneous particle concentration. The cleanroom or clean zone area is divided up into a grid of sections of near equal area, whose number is equal to the number of sampling locations derived from Table A.1. A sampling location is placed within each grid section, so as to be representative of that grid section.

It is assumed for practical purposes that the locations are chosen representatively; a “representative” location (see A.4.2) means that features such as cleanroom or clean zone layout, equipment disposition and airflow systems should be considered when selecting sampling locations. Additional sampling locations may be added to the minimum number of sampling locations.

Finally, the annexes have been reordered to improve the logic of this part of ISO 14644 and portions of the content of certain annexes concerning testing and test instruments have been included from ISO 14644-3:2005.

The revised version of this part of ISO 14644 addresses the ≥ 5 µm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S and WHO GMPs by way of an adaptation of the macroparticle concept.

The revised version of this part of ISO 14644 now includes all matters related to classification of air cleanliness by particle concentration. The revised version of ISO 14644-2:2015 now deals exclusively with the monitoring of air cleanliness by particle concentration.

Cleanrooms may also be characterized by attributes in addition to the classification of air cleanliness by particle concentration. Other attributes, such as air cleanliness in terms of chemical concentration, may be monitored and the attribute’s grade or level may be designated along with the classification of the ISO Class of cleanliness. These additional attributes do not suffice alone to classify a cleanroom or clean zone.