What is ISO 14644-1 2015 particle count?

What is ISO 14644-1:2015 Particle Count?

1. Particle Sizes and CleanRoom Classes

iso 14644-1 classifies clean rooms into nine classes, with each class allowing a different concentration of particles. The classification depends on the maximum permissible particle count of 0.5-micron or larger particles per cubic meter of air. For example:

- ISO1: 10 particles per cubic meter (≥0.5 microns)

- ISO7: 352,000 particles per cubic meter (≥0.5 microns)

These classes determine the degree of cleanliness required for specific processes. The standard provides strict limits for particles in the 0.5-micron range because this size is the most likely to interfere with critical processes such as manufacturing and research.

2. Importance of Particle Count in Cleanroom Environments

Maintaining an accurate particle count is crucial in cleanrooms to prevent contamination of sensitive products. For industries like pharmaceuticals and Semiconductors, even a small particle can ruin a product or compromise safety. As such, ISO 14644-1 requires regular particle count testing using laser particle counters to monitor and ensure compliance. 

3. Testing and monitoring Requirements

Particle counts are measured at specific locations within A CleanRoom, with the number of sample points and sampling durations determined by the size and purpose of the cleanroom. The testing is usually performed using a laser particle counter, which detects particles based on light scattering. Regular monitoring ensures that the cleanroom environment stays within acceptable limits for its class.

What is ISO 14644-1:2015 Cleanroom standard?

CleanRoom Classification

ISO 14644-1:2015 defines a classification system for cleanrooms based on airborne particle concentration, covering nine classes (ISO Class 1 to Class 9). Each class specifies maximum allowable particle concentrations to support sensitive processes like pharmaceuticals and Electronics.

Testing and Environmental Factors

The standard details requirements for testing and validating cleanroom environments to maintain designated particle counts. It also highlights the importance of monitoring other factors, such as temperature and humidity, that can affect overall cleanliness.

Compliance and Inspection

To comply with ISO 14644-1, cleanrooms must undergo regular inspections, calibrate measurement instruments, and test for adherence to class limits. This standard is crucial in regulated industries for ensuring consistent quality and minimizing contamination risks.

What is the Volume of ISO 14644-1?

Air Sampling and Test Volume:

In ISO 14644-1 testing, the volume of air sampled varies based on the cleanroom’s size and classification. Typically, active air sampling is performed, where air is pulled through a particle counter. The volume of air tested should be enough to ensure that particle count measurements are accurate and representative of the entire cleanroom environment. 

Air Change Rate and Volume Requirements:

The volume of a cleanroom also impacts the required air change rate (ACH). Cleanrooms must have an air handling system that ensures proper circulation and filtration to maintain cleanliness. Higher-class cleanrooms, such as ISO1, typically require 500 to 600 air changes per hour, while lower-class cleanrooms like ISO7 may require fewer air changes (around 60 to 90 ACH).

What are the Humidity Requirements for ISO 14644-1?

Humidity is not explicitly specified in ISO 14644-1:2015, but it is an important environmental factor that impacts cleanroom performance.

1. Impact of Humidity on Cleanliness: Humidity levels in a cleanroom can affect both particle behavior and static electricity. High humidity can lead to condensation, which can create moisture that contributes to contamination. Low humidity, on the other hand, can lead to the buildup of static electricity, which can attract and hold onto dust and other particles. For this reason, cleanrooms must maintain balanced humidity levels.

2. General Humidity Recommendations: Though ISO 14644-1 does not define specific humidity levels, cleanrooms generally maintain a relative humidity between 40% and 60% to ensure proper environmental control. This range helps minimize static electricity and reduces the likelihood of condensation forming on surfaces.

3. Industry-Specific Humidity Requirements: In some industries, such as pharmaceuticals or semiconductor manufacturing, the humidity control may be more tightly regulated to maintain stringent cleanliness standards. In these environments, narrower humidity ranges, such as 45%-55%, may be recommended. 

What is the Particle Limit for ISO?

1. Particle Limits by Class

• ISO1: Maximum of 10 particles per cubic meter (≥0.5 µm)

• ISO5: Maximum of 3,520 particles per cubic meter (≥0.5 µm)

• ISO7: Maximum of 352,000 particles per cubic meter (≥0.5 µm)

• ISO8: Maximum of 3,520,000 particles per cubic meter (≥0.5 µm)

2. Maintaining Cleanroom Classification

To maintain a cleanroom's classification, regular monitoring of particle counts is necessary. Cleanrooms that fail to meet the required particle limits can face risks of contamination, which could lead to product defects or safety hazards.

3. Particle Counting Techniques

Particle counters are used to measure and verify the particle concentration in cleanrooms. These devices measure the number of particles within defined size ranges, helping ensure that the cleanroom remains within the limits set by ISO 14644-1. Continuous monitoring and testing are key to ensuring ongoing compliance with particle limits.

Why is 0.5 Micron and 5 Micron Particle Count Required in Pharma?

Impact on Product Quality:

Particles in the 0.5- to 5-micron range are small enough to be inhaled or ingested, which means they could contaminate drugs or medical devices. Pharmaceutical cleanrooms must therefore maintain strict particle counts to prevent such contamination.

Regulatory Compliance:

Regulatory agencies like the FDA require pharmaceutical manufacturers to adhere to stringent cleanliness standards. Maintaining specific particle count limits ensures that products meet safety regulations and pass quality control inspections.

Preventing Contamination and Infection:

Maintaining low particle counts in the 0.5- to 5-micron range helps prevent airborne pathogens from contaminating drug products. This is critical for ensuring that pharmaceuticals are both effective and safe for patient use.

What are the requirements for ISO 14644-1 Class 8?

ISO 14644-1 ISO 8 Overview

ISO 14644-1 ISO 8 allows a higher concentration of airborne particles, with a maximum of 3,520,000 particles ≥0.5 microns per cubic meter. This class suits environments like food processing and general manufacturing, where cleanliness is important but less critical than in higher classes.

Compliance Requirements

To meet ISO8 standards, cleanrooms must have efficient HEPA filtration and maintain 30 to 40 air changes per hour. Regular monitoring of particle counts, airflow, and environmental parameters is essential, alongside proper maintenance and periodic validation to ensure compliance.