Cleanrooms are spaces where the air quality, temperature, and humidity remain under careful control to prevent contamination. In many sectors, like pharmaceuticals, biotechnology, and electronics manufacturing, maintaining such an environment is a must.
To ensure these areas meet the required standards, they need more than just the right design and construction. Cleanrooms need certification proving they meet the ISO cleanroom classification which is what cleanroom certification companies offer.
Below, you’ll learn all the information you need about cleanroom testing and how it’s done along with a list of companies that offer clean room certification services.
What is Cleanroom Certification?
Cleanroom certification is the process of verifying that a cleanroom meets certain cleanliness and operation standards. It’s usually done through a third-party company that ensures the space provides a controlled environment free of contaminants.
Such testing is important for industries where the tiniest particle can compromise product quality. Therefore, it needs to be performed periodically to maintain product quality and trust.
Generally, manufacturers design cleanrooms with technologies such as laminar airflow systems that direct air in a uniform flow and prevent airborne particles from spreading. They also use:
- High-efficiency particulate air and ultra-low penetration air (HEPA and ULPA) filters
- Temperature and humidity control systems
- Positive or negative air pressure
- Specialized entryways and exit points with specific procedures
- Strict protocols and protective gear for employees
Cleanroom Testing & Certification Services
The cleanroom testing and certification process mostly involves some main steps. First and foremost, an initial assessment is conducted to evaluate the design, construction, and materials used in creating the cleanroom.
Companies like CSI Testing offer many testing services to make sure your facility meets regulatory, industry, and certification requirements based on multiple standards. Besides ISO, CSI Testing ensures compliance with cGMP, FDA, CNBT, IEST, NSF standards, and more.
Here’s a list of the primary tests and services performed by most clean room testing companies:
- Airborne Particle Count: This refers to measuring the concentration of airborne particles to confirm they’re within acceptable limits. To do that, they use machines that detect and count particles of different sizes and verify compliance with ISO standards.
- Airflow Volume and Velocity: Cleanrooms must maintain consistent airflow patterns to prevent contamination. To test that, technicians use machines that generate smoke or fog to track airflow. They measure air velocity to confirm it meets design specs.
- HEPA and ULPA Filter Integrity Testing: These filters are crucial for removing contaminants of many sizes. Through cleanroom testing, companies test the filters’ overall efficiency and check them for any potential leaks.
- Room Pressurization: Using portable manometers, technicians make sure the cleanroom has proper pressure for safe operation.
- Temperature and Humidity: Testing a cleanroom’s environmental conditions and their changes is essential for maintaining a controlled space. Certification services verify these parameters are constantly within specified ranges.
- Room Air Exchange Rate: Also known as air changes per hour (ACH), this is the rate at which clean air replaces the air within the cleanroom. These calculations ensure that a sufficient supply of clean air is maintained.
- Viable or Microbial Particles: This test involves swabbing surfaces and equipment inside the cleanroom then testing them for microbial contamination. It helps in mitigating any potential sources of contamination.
- Additional Testing and Services: This includes testing for light levels, sound levels, Magnehelic gauges (including calibration and installation), filter replacements, room recovery, compressed air or gas, etc.
Companies that offer Cleanroom Certification Services
If you search for “cleanroom certification companies near me,” you’ll find multiple companies offering specialized testing services. They should help ensure your cleanroom meets cleanliness and operational standards upon request.
Here are four of the most notable companies in this field:
1. CSI Testing
CSI Testing is a prominent name in the field of cleanroom certification and contamination control that has been operating for over 45 years.
Starting small in Minneapolis, this company now covers the entire MidWest region. In addition to states like Michigan, Illinois, and Iowa, CSI Testing also services further away states such as Florida, Texas, and others.
Besides clean room certification testing, CSI Testing offers biosafety cabinet testing, fume hood inspections, and isolator certifications. One of the standout features of the company is its quick turnaround times, providing same-day reports for some tests (two weeks for cleanrooms).
Not only that, but CSI Testing is also able to provide technicians quite quickly in cases of emergencies. Such commitment, combined with high expertise, makes this company trusted for maintaining cleanroom standards.
2. Keystone
Another respected and reliable provider of cleanroom certification and testing services is Keystone. Over 25 years ago, the company started offering services for Virginia and surrounding areas. Now, it covers the whole East Coast area.
The company is proud to have a team with impressive collective experience and to have worked with over 200 clients.
Keystone also offers additional services other than cleanroom certification. This includes certifying and servicing all controlled environments like biosafety cabinets, fume hoods, and isolators.
As a company that values quality, Keystone invests in its employees’ professional and technical education. To ensure new technicians are experienced enough, the company sends them to accompany senior technicians for at least six months before conducting work independently.
3. Calyx
Calyx is a company that provides cleanroom certification and biomedical test equipment services with 30 years of industry experience. It’s built an excellent reputation for its expertise in testing, calibrating, and repairing biomedical equipment.
Serving the Mid-Atlantic, Ohio Valley, and New England areas, Calyx offers comprehensive cleanroom certification services. This includes particle monitoring, airflow and pressure testing, and filter efficiency verification.
In addition to that, the company also provides nationwide services for its depot services, covering the entire United States.
Overall, Calyx is well-equipped to handle routine and emergency testing needs. With the ability to provide accurate and timely reports, this company is certainly one of the best choices out there.
4. AT Analytical
A leading provider of cleanroom testing and certification services, AT Analytical specializes in maintaining high standards for controlled environments. It offers services for healthcare, life sciences, and pharmaceutical customers across the Midwestern United States.
For over 25 years, AT Analytical has been providing a range of services to hundreds of clients. This includes particle counting, filter integrity testing, airflow measurement, and environmental monitoring.
On the whole, this company takes pride in its thorough approach to cleanroom certification. It provides accurate data to help clients maintain optimal cleanroom conditions and comply with industry standards.
For its commitment to quality and customer service, AT Analytical is a solid partner for businesses needing expert certification and testing services.
Final Thoughts
Cleanroom certification is essential to acquire for businesses where the slightest change in environment matters. In industries like pharmaceuticals, biotechnology, and electronics manufacturing, the smallest particle can risk the final product quality.
Such industries rely on strict ISO cleanroom certification standards to ensure they meet cleanliness and operational requirements in their cleanrooms. Luckily, there are specialized cleanroom certification companies that do the necessary testing and issue these documents.
Among the most noteworthy names in the cleanroom testing field are CSI Testing, Keystone, Calyx, and AT Analytical. Each of these companies brings trustworthy expertise to cleanroom testing and delivers accurate results in a short time.
In conclusion, choosing the right company for cleanroom certification is a crucial step toward operating a business efficiently and maintaining product quality.