What are ISO cleanroom standards?

ISO cleanroom standards are a set of guidelines developed by the International Organization for Standardization (ISO). They focus on the design, construction, and operation of cleanrooms in various industries such as 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 control.

1SO cleanroom standards are as follows

There are several ISO standards, each with their own specific requirements and guidelines. Some of the most commonly used ISO cleanroom standards include:

1.IS0 14644-1: Classification of air cleanliness This standard specifies general requirements for cleanrooms, including cleanliness classification, air quality standards, and monitoring requirements based on the number and size of particles per cubic meter of air

2.IS0 14644-2: Monitoring provides evidence of cleanroom performance This standard specifies guidance for testing and monitoring cleanrooms, including sampling methods, particle concentration, and microbial monitoring

3.IS0 14644-3: Test methods

This standard provides measurement and testing performance of cleanrooms, including air velocity, air pressure, and particle count,

4.IS0 14644-4: Design, Construction and Start-up

This standard covers the design, construction and installation of cleanrooms, including requirements for ventilation systems, filters and airlocks. In addition, it covers the commissioning of cleanrooms, including the selection of materials, equipment and personnel.

5.IS0 14644-5: Operation

This standard provides for the operation and maintenance of cleanrooms, including cleaning procedures, dress code requirements and documentation. Developing an IS0-class cleanroom is an advanced process for measuring air quality.

That is why ACH’s Cleanroom design and construction process places great emphasis on determining the quality of Clean air in the cleanrooms our company builds.

ISO 14664-1 Cleanliness Standards

Below is a table of IS0 14664-1 cleanroom system standards

GMP AND ISO FEDSTD 209E USP Comparison Table

The GMP and ISO Federal Standard 209E USP comparison table highlights the key differences and similarities in cleanliness standards and requirements for controlled environments in the pharmaceutical and biotechnology industries:

ISO Standards for Air Changes per Hour

Air changes per hour are also an important standard that needs to be met to obtain IS0 Cleanroom Certification. Here are the FS209E air changes classifications: