CEN/TC 243 - Cleanroom technology

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This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions.
This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of this document to describe the nature of air chemical contaminants.
This document does not give a classification of surface chemical contamination.

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE       Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
—    specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
—    fire and safety regulations;
—    ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D.
This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm.
The following issues are not considered in this document:
—    requirements for the cleanliness and suitability of surfaces for specific processes;
—    procedures for the cleaning of surfaces;
—    material characteristics;
—    references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
—    selection and use of statistical methods for assessment and testing;
—    other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.
NOTE 1    For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface.
NOTE 2    This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the particle deposition rate and reduce the risk of particle contamination on vulnerable surfaces.
This document gives information on how a cleanroom user can use the particle deposition rate measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the particle deposition rate.
An alternative to the particle deposition rate is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The particle obscuration rate can be used in an analogous way to the particle deposition rate and the required particle obscuration rate for a specified surface can be calculated and the risk from deposited particles reduced.
This document does not:
—     provide a method to classify a cleanroom with respect to particle deposition rate or particle obscuration rate;
—     directly consider the deposition of microbe-carrying particles, although they can be treated as particles;
—     give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.

This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.
There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.
The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices.
NOTE       This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms.
This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications.
It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
-      health and safety requirements;
-      compatibility with cleaning agents and techniques;
-      cleanability;
-      biocontamination;
-      specific requirements of equipment and materials for processes and products;
-      design details of equipment.

ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644‑9 and ISO 14644‑10.
The following matters of general guidance will be provided:
-      expected surface cleanliness levels;
-      suitability of cleaning methods;
-      compatibility of surfaces with the cleaning technique;
-      assessment of cleaning appropriateness.
The following will be excluded from this document:
-      classification of cleaning methods;
-      product produced within a cleanroom;
-      specific surface-related cleaning methods;
-      detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
-      detailed material characteristics;
-      description of damage mechanisms by cleaning processes and time-dependent effects;
-      references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent;
-      other characteristics of particles such as electrostatic charge, ionic charges, etc.;
-      chemical reactions between molecular contaminants and surfaces;
-      microbiological aspects of surface cleanliness;
-      radioactive aspects of contamination;
-      health and safety considerations;
-      environmental aspects such as waste disposal, emissions, etc.;
-      selection and use of statistical methods.

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE          Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
-      assessment of suitability with respect to biocontamination;
-      testing for suitability of decontamination agents and techniques;
-      cleanability of equipment and materials;
-      requirements on design of equipment and selection of materials;
-      physical properties of materials (e.g. electrostatic, thermal properties);
-      optimizing performance of equipment for specific process applications;
-      selection and use of statistical methods for testing;
-      protocols and requirements for local safety regulations.

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.
ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm).
ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.

ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
ISO 14644-7:2004 is not applicable to full-suits.

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

ISO 14644-8:2013 establishes the classification of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.
ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2013 is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of ISO 14644-8:2013 to describe the nature of air chemical contaminants.
ISO 14644-8:2013 does not give a classification of surface chemical contamination.

ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given
ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm.
The following issues are not considered:
requirements for the cleanliness and suitability of surfaces for specific processes;
procedures for the cleaning of surfaces;
material characteristics;
references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
selection and use of statistical methods for classification and testing;
other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

ISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices.

ISO - Taking over of an ISO Technical Corrigendum

ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.

ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational.
ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

This Part of this European Standard specifies the classification of particulate cleanliness for cleanrooms and clean air controlled spaces in three possible occupancy states according to the number concentration of airborne particulate matter present.

ISO 14644-6:2007 establishes a vocabulary of terms and definitions related to cleanrooms and associated controlled environments.

ISO 14644-8:2006 covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time weighted factors within the specification for classification.
ISO 14644-8:2006 currently considers only concentrations of AMC between 100 and 10?12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2006 is not relevant for application in those industries, processes or production, where the presence of airborne molecular substances is not considered a risk to the product or process.
It is not the intention of ISO 14644-8:2006 to describe the nature of airborne molecular contaminants.
ISO 14644-8:2006 does not give a classification of surface molecular contamination.

This European Prestandard specifies the requirements for cleanroom and clean airdevice installations. This standard applies where cleanroom technology is called for and is intended for use by purchasers, suppliers and designers, providing a check list of important performance requirements. Construction and installation guidance is provided, including requirements for commissioning and qualification. Basic requirements to ensure continued satisfactory operation are identified through the consideration of operation and maintenance; further guidance in respect of these requirements is given in Annexes A to K.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Change of target dates (TC Res 40/1997)