Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½± 14644-18:2023
International Standard
Ïã¸ÛÁùºÏ²Ê¿ª½± 14644-18:2023
Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables
Edition 1
2023-10
Read sample
Ïã¸ÛÁùºÏ²Ê¿ª½± 14644-18:2023
81440
Published (Edition 1, 2023)

Ïã¸ÛÁùºÏ²Ê¿ª½± 14644-18:2023

Ïã¸ÛÁùºÏ²Ê¿ª½± 14644-18:2023
81440
Language
Format
CHF 173
Convert Swiss francs (CHF) to

Abstract

This document 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 or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered.

This document complements cleanroom operation as outlined in Ïã¸ÛÁùºÏ²Ê¿ª½±Â 14644-5.

This document gives guidance concerning:

—ÌýÌýÌýÌý determination of cleanroom suitability of consumables in general;

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

—ÌýÌýÌýÌý specification of properties for a designed use of a consumable by supplier;

—ÌýÌýÌýÌý assessment of a consumable for an appropriate use;

—ÌýÌýÌýÌý documentation.

Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.

Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables.

This document does not apply to:

—ÌýÌýÌýÌý design details of consumables;

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

—ÌýÌýÌýÌý health and safety requirements; legal requirements can apply in specific countries;

—ÌýÌýÌýÌý cleanability;

—ÌýÌýÌýÌý (raw) materials which are added within the production process as ingredients;

—ÌýÌýÌýÌý performance or function testing;

—ÌýÌýÌýÌý transport containers;

—ÌýÌýÌýÌý process media such as gases or liquids;

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

General information

Got a question?

Check out our Help and Support

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)