What Is The Difference between ISO And GMP Cleanrooms？

Definition of ISO Cleanroom

The International Organization for Standardization's ISO 14644 standard guides the designing and operating procedures of ISO Cleanrooms to control airborne particulate matter.

Characteristics

• Classification standard: The Cleanroom hierarchy spans from ISO class 1 to ISO class 9 based on airborne particle density evaluations through which ISO class 1 stands as the most sterile classification.

• Application areas: The technology finds application in semiconductor manufacturing and aerospace development together with electronics and optical manufacturing sectors which demand high-Cleanroom cleanliness.

• Control Parameters: Three main control factors include air particle count along with temperature and humidity levels and differential pressure evaluation.

Definition of GMP Cleanroom

The Good Manufacturing Practice (GMP) regulates the operation and design of GMP Cleanrooms. These facilities serve industries including pharmaceuticals and medical devices and food production because their strict microorganism and particle requirements.

Characteristics

• Classification standard: The GMP classification system defines cleanrooms in four separate levels which start from stringent level A down to least stringent level D.

• Application areas: Mainly used in pharmaceutical, biotechnology, medical equipment, food and other industries to ensure that the products are sterile and free from contamination.

• Control parameters: The control parameters include particle concentration together with microbial concentration, temperature, humidity, differential pressure, and airflow organization.