ISO 14644 : Requirements For Cleanrooms

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ISO 14644 family of standard defines the requirements for cleanroom environment, thus where sterile devices need to be manufactured. Specifically, ISO 14644 is the international standard used to design, construct, validate and operate a cleanroom.

We have extensively discussed about several topics related to sterile device, such as ISO 11135 and gamma sterilization process, packaging, and related information.

There are different ISO 14644 standards, each of them dealing with a specific aspect related to the cleanrooms, from characteristics to validation approaches and classifications.

First of all it is important to try to define what is a “cleanroom”. A “cleanroom” is an enclosed room that has equipment which controls the amount of particulate matter in the air by using air pressure and filters.

Classification of Cleanrooms according to ISO 14644

Cleanrooms are classified according to the cleanliness level of the air inside the controlled environment. The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1.

This ISO standard includes these cleanroom classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 cleanroom environment is cleaner than a regular room.

In the table below, the whole classification system with the related characteristics of the particles for each ISO class.

Class	maximum particles/m³
>=0.1 µm	>=0.2 µm	>=0.3 µm	>=0.5 µm	>=1 µm	>=5 µm
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8
ISO 4	10,000	2,370	1,020	352	83
ISO 5	100,000	23,700	10,200	3,520	832	29
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293
ISO 7				352,000	83,200	2,930
ISO 8				3,520,000	832,000	29,300
ISO 9				35,200,000	8,320,000	293,000

Controls of Cleanroom Environment

The ISO 14644 standard takes in consideration the possibility of testing Cleanrooms in three different conditions:

“As built”: in this scenario, operators perform measurements when the cleanroom is finished, though without machinery and personnel;
“At rest”: in this case, measurements shall be taken with the machinery in operation, though without personnel;
“In operation”: in this case, measurements shall be taken with the machines and personnel present and normally active.

The standard ISO 14644-1 also establishes a few essential points for a correct measurement of parameters:

The number of measurement points must not be below the square root of the surface in square metres;
The volume of air taken for each sampling point must be such to contain at least 20 particles of the larger size. In any case, the volume of air must not be below two litres and the sampling time must exceed one minute;
At least one air sample per point must be taken (three if only one measuring point exists).

ISO 14644 Family of standards

Here below we report the full list of ISO 14644 family standards related to cleanroom:

DOCUMENT	TITLE	DESCRIPTION
ISO 14644-1	Classification of air cleanliness by particle concentration	Covers the classification of air cleanliness in cleanrooms and associated controlled environments.
ISO 14644-2	Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration	Specifies requirements for monitoring and periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1.
ISO 14644-3	Test methods	This ISO Standard has not been approved as an American National Standard, and does not replace ANSI/IEST/ISO 14644-3:2005.
ISO/FDIS 14644-4	Design, construction, and start-up	Specifies requirements for the design and construction of cleanroom installations.
ISO 14644-5	Operations	Specifies basic requirements for cleanroom operations.
ISO 14644-7	Separative devices (clean air hoods, gloveboxes, isolators, minienvironments)	Specifies the minimum requirements for the design, construction, installation, testing and approval of separative devices.
ISO 14644-8	Classification of air cleanliness by chemical concentration (ACC)	Covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments.
ISO 14644-9	Classification of surface particle cleanliness	Establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environments.
ISO 14644-10	Classification of surface cleanliness by chemical concentrations	Defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements.
ISO 14644-12	Specifications for monitoring air cleanliness by nanoscale particle concentration	Covers the monitoring of air cleanliness by particles in terms of concentration of airborne nanoscale particles.
ISO 14644-13	Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications	Addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom.
ISO 14644-14	Assessment of suitability for use of equipment by airborne particle concentration	Specifies a methodology to assess the suitability of equipment for use in cleanrooms and associated controlled environments.
ISO 14644-15	Assessment of suitability for use of equipment and materials by airborne chemical concentration	Provides requirements and guidance for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments.
ISO 14644-16	Energy efficiency in cleanrooms and separative devices	Provides guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices.
ISO 14644-17	Particle deposition rate applications	Provides guidance on the interpretation and application of the results of the measurement of Particle Deposition Rate (PDR) on one, or more vulnerable surfaces in a cleanroom as part of a contamination control program.
ISO/DIS 14644-18	Assessment of suitability of consumables	Provides 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.

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