Standards Development

Scope

This document gives guidance for assessing consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. This document supports clean room operation as outlined in ISO 14644-5.

Considerations for risk mitigation and sustainability are addressed. This document is applicable to various industry branches, such as automotive, optics, biotech, pharmaceutics, food, aeronautics and space, display, semiconductor and electronics.

This document addresses personal and non-personal consumables with their cleanliness attributes as particles or chemicals in air or on surface as outlined in ISO 14644-1, -8, -9, -10, -12, -15 and -17.

Biocontamination (viable particles/microorganisms) is considered as a special property of consumables. Cleaning agents, disinfectants and lubricants are considered as cleanroom consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all cleanroom consumables.

This document gives guidance concerning:

• selection of consumables in general;

• specification of requirements for an intended use of a candidate consumable by the customer with respect to functional performance, cleanliness attributes and special properties;

• specification of properties of for a designed use of a candidate consumable by supplier;

• assessment of a candidate consumable for an appropriate use;

• documentation. Informative annexes are used to list examples for personal and non-personal consumables as well as verification methods for cleanliness attributes testing. This document does not apply to:

• design details of consumables,

• testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring;

• health and safety requirements; legal documents of a specific country shall be considered;

• cleanability;

• (raw) materials which are added within the production process as ingredient;

• performance or function testing;

• transport containers;

• process media such as gases or liquids;

• cleaning agents, disinfectants and lubricants are not considered as cleanroom consumables in respect to their functional performance.

Purpose

Use of personal consumables, such as gloves, clothing, face masks or non-personal consumables, such as wipes, textiles, flooring systems, cleaning utensils, packaging materials, foils, etc., introduced into cleanrooms, clean zones or controlled zones have a major impact on their cleanliness levels maintained for product protection.

There is a need for clear guidance on how to specify a consumable for a intended use, what kind of information to be provided by supplier’s to allow selection of a consumable for use in clean room, how to assess the suitability of a consumable for use in clean rooms, clean zones and controlled environments on how to choose the attributes of consumables for selection and appropriate use in the different cleanliness controlled areas/environments/cleanrooms.

By specifying basic requirements and by providing guidance on the process suitability of consumables the standard will provide the missing link between the cleanliness assessment/characterization of consumables and foster comparability with the cleanliness sensitive process requirements and levels. ISO/TC 209 has the competence and can provide the required expertise to address this project.