ACH Clean Room ISO Standards

What are the ISO Clean Room Standards?

ISO Standards for cleanroom are a set of guidelines established by the International Organization for Standardization (ISO). They focus on the design, construction, and operation of cleanrooms in various industries, including pharmaceuticals, biotechnology, electronics and medical devices. The purpose of these standards is to ensure that cleanrooms meet specific requirements for cleanliness, air quality, and environmental controls.

There are several different ISO standards, each with its own specific requirements and guidelines. Some of the most commonly used ISO class clean room standards include:

1. ISO 14644-1: Classification of air cleanliness
   • This standard sets forth the general requirements for clean rooms, including cleanliness classifications, air quality standards, and monitoring requirements based on the number and size of particles per cubic meter of air.
2. ISO 14644-2: Monitoring to provide evidence of cleanroom performance
   • This standard provides guidance for the testing and monitoring of clean rooms, including sampling methods, particle concentration, and microbial monitoring.
3. ISO 14644-3: Test methods
   • This standard provides methods for measuring and testing the performance of clean rooms, including air velocity, air pressure, and particle count.
4. ISO 14644-4: Design, construction and start-up
   • This standard covers the design, construction, and installation of clean rooms, including requirements for ventilation systems, filters, and airlocks. In addition, it covers the commissioning of clean rooms, including the selection of materials, equipment, and personnel.
5. ISO 14644-5: Operations
   • This standard provides guidance for the operation and maintenance of clean rooms, including cleaning procedures, gowning requirements, and documentation.

Developing an ISO Class Cleanroom is an advanced process that measures the quality of air. That is why ACH’s cleanroom design and construction process puts utmost importance to defining the quality of clean air in the cleanrooms our company manufactures.

ISO 14664-1 Standards for Cleanliness

Below is a table for the ISO 14664-1 cleanroom systems standards:

ISO Criteria for Air Change Per Hour

The Air Change Per Hour is also an important criteria that needs to be met in order to be certified as a ISO cleanroom. Below are the FS209E classifications for Air Change Rate:

Overall, compliance with ISO clean room standards is essential for ensuring the safety and efficacy of products and processes in industries where contamination can have serious consequences.