Guarantee a contamination-free environment and maintain operational integrity and regulatory compliance with Allometrics cleanroom certification and testing services.
What is a Cleanroom?
A cleanroom is an enclosed environment used for manufacturing items that require a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. Aside from manufacturing facilities, scientific research and tech labs also utilize cleanrooms.
Cleanrooms or Controlled Environment Areas (CEA) are custom-built rooms in which the concentration of airborne particles and other parameters are closely monitored and controlled.
Cleanroom facilities are common in:
- Pharmaceutical Production Labs
- Biotechnology Research Facilities
- Aerospace Manufacturing Plants
- University Research Labs
Why Is Cleanroom Certification Important?
Cleanrooms are classified by how clean the air is, based on the number and size of particles permitted per volume of air.
In the United States, there are different standards used to classify cleanrooms:
- Federal Standard 209 (A to D)
- Federal Standard 209E (Used Domestically)
- TC 209 from the International Standards Organization
- ISO 14644-1, ISO 14644-2, and ISO 14644-3
The importance of performing routine testing to certify that cleanrooms comply with current domestic and international standards is vital to quality assurance programs.
Allometrics’ highly trained CETA-certified, NEBB-certified and NSF-accredited technicians will certify your cleanroom as well as conducting a wide range of tests in accordance with Current Good Manufacturing Practices (cGMP), ISO and federal standards.
Our team certifies these environments with the use of specialized calibrated instruments to comply with quality and regulatory testing.
When Should Cleanrooms Be Tested and Certified?
A cleanroom should be tested and certified when its construction is completed to ensure it complies with the required standards based on the industry.
After this, the cleanroom will need routine retesting either annually or semiannually to make sure the quality of the air has not changed during operations.
Cleanroom testing and certification also need to be done after a renovation or a contamination incident.
Types of Cleanroom Tests
At Allometrics, we conduct cleanroom testing and certification with the following occupancy states:
- Initial State: This is the state the room is in when first built, and the facility is empty.
- At Rest: In this state, all the production equipment is in place and running, but no personnel present inside the cleanroom.
- Operational: This is when both the production equipment is running, and the staff is working inside the cleanroom
The type of tests performed vary depending on several factors. However, in most cases, compliance with current standard requirements is what determines the kind of test we conduct. Other factors include the client’s preferences as well as the auditing agency or client needs.
Our standard cleanroom tests include:
- Airflow Volume / Velocity Readings
- HEPA Filter Integrity Testing
- HEPA Filter Velocity/Volume
- Non-Viable Particle Counting
- Room Pressurization Testing
As part of our optional testing, our clients can choose to perform any of the following:
- Air Balancing
- Viable Air Sampling
- Airflow Visualization Testing/ Smoke Testing
- Viable Environmental Monitoring (EM)
- Room Air Exchange Rates
- Temperature/Relative Humidity Testing
- Lighting, Vibration, and Sound Testing
- Room Pressure
- Room Recovery
- Viable Surface Sampling
Cleanroom Certification Documentation
Allometrics tailors all cleanroom testing and certification to each site, considering the client’s requirements as well as industry, domestic, and international standards guidelines.
Additionally, we offer flexible reporting formats, as well as the capability to compile, check, and issue custom reports onsite, which help to minimize downtime and hasten the validation and approval process.
All cleanroom certification documentation provided by Allometrics includes the following:
- Summary of testing results and the defined acceptance standard for each test conducted
- Site-specific test methods used
- Blueprints detailing the layout of your facility and the location of the test measurements
- All raw data collected
- Certification for each test conducted
- Calibration certificates for the test equipment used
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