Standards: Cleanrooms in the BSI spotlight

Standards: Cleanrooms in the BSI spotlight

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Standards:

Cleanrooms in the BSI spotlight C

leanroom and associated controlled environments are important facilities for controlling airborne particulate contamination in industries such as pharmaceuticals, microelectronics, medical devices and food. We asked Frank Thomas (BSI) for an overview of the BSI standards.

What is a cleanroom? In the standards that will be discussed in this article, a cleanroom is defined as: “a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.” The International Organisation for Standardisation’ s (ISO) technical committee in this area is ISO/TC 209, Cleanrooms and associated controlled environments. The aim of ISO/TC 209 is to cover the standardisation in this area with respect to equipment, facilities, and operational methods (including procedural and operational limits and testing procedures). The secretariat of ISO/TC 209 is held by the Institute of Environmental Sciences and Technology in the USA. Up until this point its standards have been adopted for use in Europe by the European standards body CEN and then for use in the UK by the British Standards Institution (BSI). (see box on page 39 – what BSI standards are available?)

What area does each standard cover? BS EN ISO 14644-1:1999 Cleanrooms and associated controlled environments. Classification of air cleanliness This part of BS EN ISO 14644 covers the classification of air cleanliness in

cleanrooms and associated controlled environments. This is based solely on the concentration of airborne particles. Only particle populations having cumulative distributions based upon threshold sizes ranging from 0.1µm to 5µm are considered for classification purposes. The remainder of the standard specifies how users can demonstrate compliance. Annexes provide requirements for how the particulate cleanliness classification can be determined using a discrete-particlecounting light scattering instrument, and on the statistical treatment of particle concentration data.

BS EN ISO 14644-2:2000 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 This part of the standard was developed to assist users in demonstrating continued compliance with part 1, and specifies the minimum requirements for testing and monitoring. It specifies the test methods to be used, and the maximum time interval between tests.

BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments. Test methods This part of the standard specifies the test methods for the classification of airborne particulate cleanliness and for characterising the performance of cleanrooms and clean zones.

In addition to the normative airborne particulate count the optional tests that are covered are: • Airborne particle count for ultrafine particles (less than 0.1µm); • Airborne particle count for macro particles (greater than 5µm); • Airflow test; • Air pressure difference test; • Installed filter system leakage test; • Airflow direction test and visualisation; • Temperature test; • Humidity test; • Electrostatic and ion generator test; • Recovery test; • Containment leak test. [Note: Items 3 and 4, though optional tests, are required by BS EN ISO 14644-2].

BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction and start-up This is intended to be used by purchasers, suppliers and designers for the design and construction of cleanroom facilities. It does not lay down specific technological or contractual means on how the requirements should be met, but annexes provide information on: • Control and segregation concepts; • Classification examples; • Approval of an installation;

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What BSI standards are available? Standards are codes of best practice that improve safety, efficiency, interoperability and facilitate trade. In the area of cleanrooms, the following BSI standards are available: • BS EN ISO 14644-1:1999 – Cleanrooms and associated controlled environments. Classification of air cleanliness; • BS EN ISO 14644-2:2000 – Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1; • BS EN ISO 14644-3:2005 – Cleanrooms and associated controlled environments. Test methods; • BS EN ISO 14644-4:2001 – Cleanrooms and associated controlled environments. Design, construction and start-up; • BS EN ISO 14644-5:2004 – Cleanrooms and associated controlled environments. Operations; • BS EN ISO 14644-7:2004 – Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators and minienvironments); • BS EN ISO 14644-8:2006 – Cleanrooms and associated controlled environments. Classification of airborne molecular contamination; • BS EN ISO 14698-1:2003 – Cleanrooms and associated controlled environments. Biocontamination control. General principles and methods; • BS EN ISO 14698-2:2003 – Cleanrooms and associated controlled environments Biocontamination control. Evaluation and interpretation of biocontamination data.

BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments. Operations This recognises the importance of operational procedures on cleanliness levels achieved during the operation of the cleanroom. It specifies the basic requirements for cleanroom operations and informative annexes cover: • Operational systems; • Cleanroom clothing; • Personnel; • Stationary equipment; • Materials and portable equipment; • Cleanroom cleaning.

BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators and minienvironments) The term separative devices was adopted by ISO/TC 209 to cover devices stretching from open unrestricted air overspill to fully contained systems. It specifies the minimum requirements for the design, construction, installation, test and approval of separative devices (where they differ to the cleanrooms described in parts 4 and 5). Access and transfer devices are considered.

BS EN ISO 14644-8:2006 Cleanrooms and associated controlled environments. Classification of airborne molecular contamination. This recently published part extends the coverage of ISO 14644 to airborne molecular contamination (AMC). It provides a classification scheme which results in an AMC descriptor of the form: • ISO-AMC Class N(X)(where N is the ISOAMC class and X is used to denote a contaminant).

BS EN ISO 14698-1:2003 Cleanrooms and associated controlled environments. Biocontamination control. General principles and methods

• Control of air cleanliness;

This is the first general BS EN ISO standard for biocontamination control. It establishes the principles and basic methodology of a formal system of biocontamination control. It specifies the methods required for monitoring risk zones and for applying control measures. It does not give application-specific requirements due to its generic nature.

• Additional specification of requirements to be agreed upon between purchaser/user and designer/supplier.

BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments

• Layout of an installation; • Construction and materials; • Environmental control of cleanrooms;

As the name would suggest, keeping a cleanroom free of bacteria is vital; this researcher is filling monoclonal antibodies.

Biocontamination control. Evaluation and interpretation of biocontamination data This part of the standard gives guidance on methods for the evaluation of microbiological data, as well as the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. This concludes the review of the ISO/TC 209 standards that have been adopted in the UK however, three others are under development:

BS EN ISO 14644-6 Cleanrooms and associated controlled environments. Vocabulary This standard will provide the terms and definitions applicable to the ISO/TC 209 cleanroom standards.

BS EN ISO 14644-9 Cleanrooms and associated controlled environments. Classification of surface particulate cleanliness This part of BS EN ISO 14644 will extend the standard to cover the classification of particle contamination of surfaces in cleanrooms and associated environments. It is at an early stage of development.

Cleanrooms and associated controlled environments. Classification of surface chemical contamination This standard is also at an early stage. It is intended that it will provide a classification system of the surface contamination due to chemical compounds or elements. Once these standards are published ISO/TC 209 will have produced a suite of documents providing an invaluable resource for designers, specifiers, and users of cleanrooms and associated controlled environments.



Author: Mr Frank Thomas, British Standards Institution, E: [email protected]

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