Glossary · ISO and IEC standards for MedTech and pharma

ISO 14644-1

Also known as: ISO 14644-1:2015, EN ISO 14644-1, Cleanroom classification, ISO Class 5

ISO 14644-1 is the international standard for classifying the air cleanliness of cleanrooms and clean zones by airborne particle concentration. It defines ISO Class 1 to ISO Class 9 by maximum particle concentrations for particle sizes from 0.1 to 5 µm and specifies how classification tests are performed.

Standards
GxP
Pharma

In one sentence

ISO 14644-1:2015 classifies cleanroom air cleanliness by particle concentration into ISO Class 1 to 9 and sets the classification test method.

Example

A contract manufacturer of sterile injectables classifies its filling line at rest and in operation to ISO 14644-1, with sampling locations derived from the room area, and reports the results as part of the cleanroom qualification under EU GMP Annex 1.

How it applies

Classes: ISO Class 1 is the cleanest and ISO Class 9 the least clean. A classification states the class, the particle sizes considered and the occupancy state: as-built, at-rest or operational.
Test method: The number of sampling locations is derived from the cleanroom area, and the result at each location must meet the class limit. Particle counters must be calibrated; see calibration.
Classification vs. monitoring: ISO 14644-1 covers classification at a point in time. Ongoing monitoring is addressed by ISO 14644-2 and, in pharma, by the environmental monitoring requirements of EU GMP Annex 1.
Medical devices: Manufacturers of sterile or low-bioburden devices use ISO 14644-1 classes to specify controlled environments within their ISO 13485 QMS.
Technical documentation: The classification report, sampling plan, counter calibration certificates and deviations are part of the qualification records of the facility and must be repeated at the intervals the site defines or regulations require.

ISO 14644-1 cleanroom classes vs. EU GMP Annex 1 grades

The two are related but not identical. EU GMP Annex 1 uses grades A to D for the manufacture of sterile medicinal products and refers to ISO 14644-1 for classification: Grade A corresponds to ISO Class 5 at rest and in operation, Grade B to ISO 5 at rest and ISO 7 in operation, Grade C to ISO 7 at rest and ISO 8 in operation, and Grade D to ISO 8 at rest. Annex 1 adds limits for particles of 5 µm and larger, microbial limits and monitoring requirements that ISO 14644-1 doesn't contain. An ISO Class 5 certificate alone doesn't show that a zone meets Grade A.