EN ISO 14644 Airborne Particle Testing in Controlled Environments
The CEN standard EN ISO 14644-1 provides the principles and basic requirements for classification of cleanrooms and associated controlled environments. This service ensures that airborne particle levels within controlled environments meet stringent cleanliness specifications as defined by this international standard.
Controlled environments, such as pharmaceutical manufacturing facilities, semiconductor fabrication plants, and biotechnology research labs, require precise air quality control to maintain product purity and personnel health. Airborne particles can significantly impact the integrity of products in these spaces; hence, periodic testing is essential for compliance with regulatory standards.
The test involves sampling ambient air within a controlled environment using specialized equipment such as impactors, centrifugal samplers, or optical particle counters. Samples are then analyzed according to ISO 14644-1 guidelines, which specify the acceptable concentration limits for particles of various sizes in different classification levels.
The testing process is labor-intensive and requires expertise to ensure accurate sampling and analysis. Our laboratory adheres strictly to ISO 14644 procedures to deliver reliable results that support your compliance efforts and help maintain a safe working environment.
Applied Standards
| Standard | Description |
|---|---|
| EN ISO 14644-1 | This standard provides the principles and basic requirements for classifying cleanrooms and associated controlled environments. It specifies criteria for air cleanliness, including particle concentration limits. |
| ASTM E2809 | American Society for Testing and Materials standard that provides a guide for the sampling of airborne particles in cleanroom environments. |
| IEC 60312 | Institute of Electrical and Electronics Engineers standard for measuring particle size distribution. |
The use of these standards ensures that our testing procedures align with industry best practices, providing you with accurate and reliable results. Compliance with EN ISO 14644-1 is crucial for maintaining the integrity of your controlled environments and ensuring that they meet regulatory requirements.
Benefits
Regular airborne particle testing in controlled environments offers numerous benefits:
Ensures compliance with international standards such as EN ISO 14644-1, which is essential for maintaining the quality of products and services.
Reduces the risk of contamination, safeguarding both your products and personnel health.
Aids in identifying potential sources of airborne particles, allowing for timely corrective actions to be implemented.
Enhances the reputation of your facility by demonstrating a commitment to maintaining high standards of hygiene and quality control.
In summary, this service is vital for industries where product purity and personnel safety are paramount. By adhering to EN ISO 14644-1, you can ensure that your controlled environments remain at the highest level of cleanliness, thereby protecting your business interests.
Quality and Reliability Assurance
To uphold the highest standards in our airborne particle testing services, we implement a robust quality assurance framework. This includes:
Strict adherence to ISO 14644-1 guidelines for sampling and analysis.
Regular calibration of all analytical equipment used in the testing process.
Training of our staff on the latest techniques and methodologies for accurate particle counting.
Documenting each test with detailed records that can be reviewed by your compliance officers or regulatory bodies.
We ensure that every aspect of our testing process meets the stringent requirements set forth in EN ISO 14644-1, providing you with confidence in the reliability and accuracy of our results.
