ANSI/IEST/ISO 14644-18, Assessment of suitability of consumables

In ANSI/IEST/ISO 14644 Cleanrooms and associated controlled environments – Part 18: Assessment of suitability of consumables, the focus is on consumables that are widely used during preparation and operations in cleanrooms, clean zones or controlled zones to maintain the air or surface cleanliness level in the cleanroom by shielding a contamination source or a vulnerable object or by removing contamination from a surface. For monitoring and testing purposes, consumables may be used for sampling contamination. Consumables need to be carefully selected and appropriately used in order to maintain cleanliness levels and mitigate risk for processes and products. This document addresses the assessment of suitability of consumables for being used in cleanrooms, clean zones or controlled zones in respect to contamination in air and on surfaces by:

— particles,
— chemicals, or
— microorganisms.

Scope of ISO 14644-18

This part of the ISO 14644 standards gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles/microorganisms) is considered as a special property of consumables. Identification of associated risks are considered.

This document complements cleanroom operation as outlined in ISO 14644-5.

This document gives guidance concerning:
— determination of cleanroom suitability 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 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, verification methods for cleanliness attributes testing as well as the potential impact of consumables on a cleanroom.

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 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;
— the functional performance of cleaning agents, disinfectants and lubricants.

View list of ISO 14644 Standards