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Cleanroom Certification

Jeremy James

Updated: May 1, 2024

Sinergix Cleanroom Testing & Certification.

Cleanroom certification is a critical aspect of maintaining a clean and controlled

environment for various industries such as pharmaceuticals, biotechnology, electronics, and medical device manufacturing. Cleanrooms are designed to ensure that particles, dust, and microorganisms are kept at minimal levels to prevent contamination of products and ensure quality control.


To achieve cleanroom certification, facilities must first meet the standards set forth by

organizations such as the International Organization for Standardization (ISO) and the

United States Federal Standard 209E. These standards outline the requirements for

cleanliness, air quality, and particle control within a cleanroom environment.


The certification process involves thorough testing and validation to ensure that the

cleanroom meets the designated classification levels. This includes testing for airborne

particles, air velocity, temperature, humidity, and pressure differentials. Cleanrooms are

typically classified based on the number of particles per cubic meter at a specified

particle size, with Class 1 being the cleanest and Class 9 being the least clean.

The certification process is usually conducted by qualified and accredited third-party

testing/certification companies that specialize in cleanroom testing. Specialized

equipment such as particle counters, air sampling devices, photometers, and airflow

velocity meters to measure various parameters within the cleanroom environment.


Once the testing is complete and the cleanroom meets the required standards, a

certification report is issued detailing the results of the tests and confirming that the

cleanroom is compliant with the specified classification levels. This report is typically

valid for a specified period, after which the cleanroom must be re-certified to ensure

continued compliance.


Maintaining cleanroom certification is crucial for industries that rely on cleanroom

environments to ensure the quality and safety of their products. Failure to maintain

certification can result in costly product recalls, loss of reputation, and potential

regulatory fines.


Overall, cleanroom certification is a critical component of ensuring the quality and safety

of products produced in cleanroom environments. By adhering to strict standards and

maintaining certification, industries can confidently produce products that meet the

highest quality standards and regulatory requirements. Investing in cleanroom

certification is an investment in the reputation and success of a business.


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