Views: 0 Author: Site Editor Publish Time: 2025-04-02 Origin: Site
In modern industrial production, especially in the pharmaceutical, food, and semiconductor industries, Clean Room standards are of paramount importance. ISO and GMP are two oft-repeated concepts, each with different requirements for Clean Rooms.
ISO (International Organization for Standardization) is an international standardization body responsible for the development and promotion of various international standards. ISO quality management system standards (e.g., ISO 9000 series) are generic quality management system standards designed to provide guidance for enterprises to establish a sound quality management system in order to improve product quality, customer satisfaction and market competitiveness.
ISO 1 through ISO 9, the smaller the number, the higher the cleanliness.
Each class has a clear limit on the concentration of particulate matter. For example, in ISO Class 5, the number of particles greater than or equal to 0.5μm must be less than 3520 particles per cubic meter of air. The measurement methodology is strictly in accordance with the ISO standard to ensure the accuracy and comparability of the data.
GMP (Good Manufacturing Practice), has the core objective of ensuring the ultimate cleanliness and hygiene of the pharmaceutical manufacturing environment.
GMP is a specialized standard for the pharmaceutical industry that aims to ensure hygiene, accuracy and traceability in the manufacturing process of pharmaceutical products in order to produce high quality, safe and reliable products.
Although ISO and GMP have different emphases, there is a certain correspondence between them. For example, a Class A clean area in GMP corresponds roughly to ISO Class 4.8, while Class B is equivalent to ISO Class 5 under static conditions. This means that in a GMP environment, cleanrooms of different classes can be designed and validated with reference to ISO standards.
