ISO 14644 Clean Room Standards
What are the Proposed Changes to the ISO 14644 Clean Room Standards?
The ISO 14644 Clean Room Standards that cover clean room classification and testing have been revised in recent years with changes due to come into effect in 2013. These revisions are likely to embrace mandatory changes with regards calibration policy, equipment selection and SOP or IQ/OQ relating to optical particle counters used for the purposes of environmental non-viable monitoring. To make sure that you are fully prepared for this it is important to understand the history and content of the current family of ISO 14644 Clean Room Standards.
The History of the ISO 14644 Clean Room Standards:
Originally clean room classification and standards in the US were covered by the US Federal Standard 209E which was first published in 1963. This described six classes of cleanliness from 1 through to 100,000 where the class number related to the maximum number of 0.5 micron (or larger) particles that were acceptable in air. Class 1 and Class 10 being the highest standard reserved for electronics manufacture (eg integrated circuits and silicon chips) and Class 100,000 being the lowest standard covering for example ball bearing manufacture. As clean rooms became more sophisticated the need for wider ranging standards was recognized and this led to the formation of a technical committee at the International Standards Organization. The goal of Technical Committee 209 was the “standardization of equipment, facilities, and operational methods for clean rooms and associated controlled environments. This includes procedural limits, operational limits and testing procedures to achieve desired attributes to minimize micro contamination”. In 1999 ISO 14644-1 was published and shortly afterwards this officially superseded Fed 209E.
The Family of ISO 14644 Clean Room Standards:
Here is a complete list of the ISO 14644 Clean Room Standards which have been published since 1999…..
|ISO 14644-1:1999 clean rooms and associated controlled environments — Part 1: Classification of air cleanliness||This document describes the classification of clean rooms exclusively in terms of the concentration of airborne particles.|
|ISO 14644-2:2000 clean rooms and associated controlled environments — Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1||This document describes the testing requirements needed in different clean zones.|
|ISO 14644-3:2005 clean rooms and associated controlled environments — Part 3: Test methods||This document describes both the test methods and the equipment needed to carry out clean room monitoring.|
|ISO 14644-4:2001 clean rooms and associated controlled environments — Part 4: Design, construction and start-up||This document covers all aspects from clean room design right through to start-up and commissioning.|
|ISO 14644-5:2004 clean rooms and associated controlled environments — Part 5: Operations||This document describes how to use a clean room…entry and exit, clothing etc|
|ISO 14644-6:2007 clean rooms and associated controlled environments — Part 6: Vocabulary||This document provides a complete definition of all clean room related terminology so that there is a consistency of use.|
|ISO 14644-7:2004 clean rooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)||This document covers standalone clean spaces or devices.|
|ISO 14644-8:2006 clean rooms and associated controlled environments — Part 8: Classification of airborne molecular contamination||This document describes the measurement and classification of molecular contamination in clean zones.|
|ISO 14644-9 Classification of surface particle cleanliness — Part 9:||This document is currently in a draft form at the time of writing (September 2012)|
Relationship Between ISO 14644 and ISO 21501:
ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the Life Sciences industry with the increasing trend for real-time air particle monitoring in clean rooms using light scattering air particle counters. Part 4 covers light scattering airborne particle counters for use in clean rooms.
For clean room users aseptically manufacturing pharmaceutical products for the European and American markets, there is a requirement to follow the guidelines in EU GMP and cGMP respectively. Both documents define the airborne particulate count limits for different clean room operations, but neither defines the methods required to determine these count limits, nor do they define the instrument to be used and how it should be calibrated. However, EU GMP states that ISO 14644-1 should be used for methodology to determine clean room air particle cleanliness classification and that ISO 14644-2 should be used for methodology for demonstrating continued compliance. The introduction in ISO 21501-4 states “Monitoring particle contamination levels is required in various fields, e.g. in the electronic industry, in the pharmaceutical industry, in the manufacturing of precision machines and in medical operations. Particle counters are useful instruments for monitoring particle contamination in air. The purpose of this part of ISO 21501 is to provide a calibration procedure and verification method for particle counters, so as to minimize the inaccuracy in the measurement result by a counter, as well as the differences in the results measured by different instruments.” The scope of ISO 21501-4 states “Instruments that conform to this part of ISO 21501 are used for the classification of air cleanliness in clean rooms and associated controlled environments in accordance with ISO 14644-1″. So the importance of ISO 21501 to clean room users looking to follow the guidance in GMP is evident.
During 2013 changes are scheduled to the ISO 14644 Clean Room Standards that will impact calibration policy, equipment selection and SOP and or IQ/OQ of optical particle counting products used in manufacturing environments adhering to ISO 14644 and EU-GMP. In 2013, a requirement for ISO21501-4 compliant calibrations for Air Particle Counters will be reflected in the normative Appendix C of the ISO 14644-3 standard and as a result, calibration of air particle counting equipment to the ISO 21501-4 standard will become mandatory for aseptic filling under EU-GMP which itself references ISO 14644. This in effect completes the circle.
Since 2005 HACH realized the importance and significance of these changes and have developed new air particle counting products that embrace the performance criteria required by ISO 21501-4. However, there remains a large installed base of older installed MET ONE Air Particle Counters such as the 3300 and 2400 series which will not comply with the changes. At HACH we are committed to supporting our customers with the information and options necessary for informed decisions, and we understand that the risk of non-compliance is an everyday concern.
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