scope:

This standard deals with the control and determination of chemical contamination in cleanrooms in order to protect process, product and personnel. It specifies general principles for the treatment, handling, avoidance and reduction of chemical contamination in cleanrooms.

These principles are based on the performance characteristics of established and available technical solutions and the economic characteristics of these solutions.

The fact that media other than air can also bear chemical contaminations which affect processes, products and personnel shall be noted expressly. This is particularly true for water, aqueous solutions, further process liquids and process gases. The chemical contamination of these media has impacts in all producing industries concerned, such as the semiconductor, optical, food and luxury food, pharmaceutical, geneticand medical-engineering industries. Molecular contamination in liquid and gaseous process media, however, is not within the scope of this standard.

The scope of this standard includes all production and storage areas of the industries concerned, which are subject to cleanroom conditions, where products and processes can be affected by chemical contamination.

Examples of the industries concerned are (list not claiming to be exhaustive):

• semiconductor and nanotechnology
• microsystems and printed circuit boards
• plastics engineering
• optical industry and imaging processes
• pharmaceutical and biotechnology
• medicine and medical engineering
• hospitals and hospital pharmacies
• surface treatment and surface finishing
• food and luxury food
• aerospace
• automotive
• production of telecommunication and IT components and systems
• chemical

For the purpose of this standard, the term "cleanroom" includes, among others,

• buildings and parts of buildings with active or passive technical equipment suitable for creating controlled environmental conditions with regard to the thermodynamic states of the air, the air constituents and the contamination of media, surfaces and products,
• including, in particular, separated environments with a small volume and rooms which are part of a cleanliness cascade, such as production cells (separative devices like mini-environments/isolators) or storage containers, see also VDI 2083 Part 16.1 and DIN EN ISO 14644-7.

The following are regarded as sources of chemical contaminations:

• air pollutants

- occurring in the gaseous state or in the form of aerosols (which can be re-vaporised) in the environment in question

- capable of affecting a solid product surface, either directly or indirectly (i. e. coming into effect at later production stages), the effect being a permanent chemical or physical change, as, e. g., in the case of a chemical reaction

- capable of affecting a liquid product surface, e. g. by their transition into a solution, which changes the composition or the physico-chemical characteristics of the product

- capable of affecting the surface of a biologically active entity, e. g. by means of a chemical reaction or their transition into a solution being part of the biologically active entity

• metabolic products of airborne microorganisms which are capable of interacting with the constituents of the media or products, thus effecting a permanent change of the media or products

The cleanliness of cleanroom air according to chemical concentration is specified in DIN EN ISO 14644-8 (see also Annex A).