ISO 14644-1:2015 Revisions Summary

Abstract

220-ISO-14644-Revisions-Summary-3.jpgThe recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

Introduction

Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and -2.

The ISO community voted in favor of the revision to update and improve the standard specifically to:

  • simplify the classification process, and if possible, remove the need to evaluate the 95% upper confidence limit (UCL) for low sample location numbers (currently required for 2/9 of cleanroom locations).
  • review the classification procedure and make it more applicable to cleanroom operation. In this situation, the contamination is not expected to be evenly distributed; an assumption the current statistical approach makes.
  • generally, update the standard as required to current thinking and industry requirements.
  • avoid any radical change to the principles of the current ISO cleanliness classes 1÷9.

The same technical committee has also been working on the revision of the ISO 14644-2:2000 (not analyzed in this document) in conjunction with the revision of ISO 14644-1. The ISO community voted in favor of the revision to improve the ISO 14644-2:2000 standard to:

  • simplify and clarify requirement and guidance tables that specify frequency of testing and monitoring of cleanrooms used to demonstrate continued compliance with the cleanliness classification.
  • refine how these intervals may be extended, provided that automated monitoring systems show the cleanroom is under control.
  • provide new guidance on aspects that should be considered when configuring a monitoring system for a cleanroom.

 

On October 29th 2015, during the last voting session, the revised 14644-1 and -2 Standards were approved by a significant majority of the member nations participating in the ISO/TC 209 committee.

Definitions

To simplify ISO 14644-1:2015, summaries are provided below of sections relevant to the revisions.

ISO 14644-1:2015

Cleanrooms and Associated Environments

Part 1. Classification of air cleanliness by particle concentration

This section specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations.

ISO 14644-1 Introduction

ISO 14644-1 represents the first chapter of a series of documents, which describe the method, procedures and limits to be applied in the cleanroom design, operation and controls. This standard is used in different industries including Microelectronics, Pharmaceuticals, Aerospace, Medical Devices, Healthcare and Food Production.

It specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes a strategic selection of sampling locations.

ISO 14644-1 Scope

The scope of this International Standard is to provide guidelines, specifications and rules to be used for cleanroom certification in terms of airborne particle concentration. ISO 14644-1 addresses all consideration for classification purposes that have cumulative distributions based on threshold (lower limit) sizes ranging from 0.1 µm to 5 µm. Lower particles size concentration limits (nanoparticles), are addressed in ISO 14644-12.

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