Sectors such as electronics, pharmaceuticals, biotech, healthcare, and aerospace depend on cleanroom technologies to ensure safety and the highest-quality products.
However, when designing such controlled environments, they must adhere to stringent guidelines and industry standards set by the International Organization for Standardization (ISO) and other governing bodies.
To do this, all cleanrooms must undergo and pass a series of evaluations and compliance testing to receive permission to operate.
Many companies offer cleanroom certification services. But if you’re to meet top-tier cleanliness and operational standards, here are the top 10 cleanroom certification companies approved by leading industry experts.
Founded in 1975, CSI Testing is a trusted cleanroom compliance specialist and certification provider that’s been around for 45 years.
The company is the second-ever to offer cleanroom compliance testing services in the US.
CSI Testing assesses and certifies biosafety cabinets, fume hoods, isolators, and electronic cleanrooms. It serves many states in the US, including Minnesota, Michigan, Illinois, Iowa, Texas, Florida, and more.
With evaluations designed to meet ISO, CNBT, FDA, IEST, NSF, and more, you can rest assured your controlled environment is up to par with the most rigorous regulatory requirements.
Reports are given the same day for hoods and BSCs, plus a convenient emergency service in case you need a technician on the fly.
Although relatively young, Keystone Certification is another expert-driven cleanroom testing and certification company you can rely on. It was launched in Chesapeake, Virginia, in 2010, and is proud to be founder and employee-owned.
Preferred for its regulation-focused services, Keystone offers cleanroom compliance evaluation and certification across the East Coast and the mid-Atlantic.
Keystone takes great pride in its veteran-led team with over 100 years of cumulative industry experience.
Within 25 years, the company has served hundreds of academic institutions, biotech, healthcare, research, and electronic manufacturing clients.
Keystone does standard cleanroom, biosafety cabinet, fume hood, and laminar flow hood appraisals, but it also provides expert advice on controlled-environment design, operational audits, and SOP coaching.
Class One Air is a Milwaukee-based environmental compliance testing company specializing in air-quality control and certifications. It boasts the largest team in Midwest America, with accredited and experienced technicians.
The firm is a proud partner of the Scientific Safety Alliance (SSA), a leading name in safety services for scientific and healthcare equipment and facilities.
Healthcare facilities and laboratories prefer Class One Air for its lightning-fast report turnarounds. Prioritizing emergencies, they can send expert technicians to your site with one call.
In addition to its core validation services, Class One Air does compressed air testing, filter and duct cleaning, consultation, and gap analysis. It also supplies essential air filters for various industry uses.
Established in 1985, Calyx Metrology has built a solid reputation in calibrating, testing, and repairing biomedical equipment in the healthcare industry.
Calyx has been in the business for 30 years and has served countless customers across the mid-Atlantic, Ohio, and New England. Over half of the clinics listed in Forbes’ list of 100 best hospitals in those areas have worked with Calyx Metrology.
The team’s accredited calibration process managers regularly handle issues with flow meters, patient simulators, pressure systems, amplifiers, oscilloscopes, and other medical and precision lab instruments.
With a focus on quality assurance, Calyx Metrology staff undergo regular intensive training and professional education programs backed by CETA, IEST, NSF, NEBB, and Eagleson Institute.
Boasting decades of professional experience in cleanroom maintenance, repairs, testing, and accreditation, RX Cleanroom via AT Analytical is a veteran-owned company based in Baltic, South Dakota.
As a major partner of SSA, RX assures quality service that complies with the highest industry standards.
RX has served hospitals, laboratories, research facilities, and pharmacies since 1998. It boasts a dozen trained technicians prepared to assist in major cities around South Dakota, North Dakota, and Nebraska.
If you’re looking for a one-stop support for ISO cleanroom accreditation, equipment calibration, microbiological laboratory, and other crucial repairs, RX Cleanroom has it all and more.
Offering comprehensive equipment maintenance, calibration, and repairs, BME Lab and Science has been a trusted lab-equipment partner for research, medical, and healthcare facilities since 1981.
The company is based in Little Canada, Minnesota, but operates across various states, including Wisconsin, Iowa, South Dakota, North Dakota, Kansas, Missouri, Nebraska, and Illinois.
Serving for more than 40 years, BME Lab and Science maintains an excellent reputation for its commitment to high-quality, NIST-traceable services that meet all compliance needs.
BME Lab and Science partners with several leading manufacturers in the country. And its rates are known for being reasonable without compromising quality.
Certified by the National Environmental Balancing Bureau (NEBB), Nemar Technology Group is a reliable firm to hire for HVAC servicing and cleanroom testing.
The group’s founders are licensed engineers who originated in San Juan, Puerto Rico, but now serve over 23 states. They currently have nine experienced technicians and staff members trained to serve at any time.
Nemar Tech has built an impressive portfolio in its 22 years in the industry, amassing a significant client base. Some of the key customers they serve are Merck, CPI, Warner Lambert, and GlaxoSmithKline.
SGS started as a grain inspection house in Rouen, France, in the ‘70s. Now, it’s considered one of the top inspection, testing, and validation companies worldwide, with over 2,500 offices operating in over 115 countries.
That’s a massive team of 99,500 tech professionals supporting and executing SGS’s operations.
The company has an extensive portfolio. However, its core services primarily involve cleanroom assessments and certifications, medical equipment auditing, environmental testing, and laboratory calibrations.
To help you achieve the highest quality standards, SGS SA works alongside Brightsight, Maine Pointe, Nutrasource, and Bluesign to deliver its 145 years of expert excellence at your doorstep.
Based in Maryland and Texas, VALogic Bio has performed over 150,000 calibrations, monitored more than 45,000 biotech units, and served 600-plus satisfied customers.
VALogic offers a wide range of reliable services besides handing out controlled-environment certifications, which include GxP consulting, facility maintenance, and GMP monitoring and storage.
For those in need of a cleanroom on short notice, VALogic offers temporary, GMP-grade controlled rooms for rent with flexible lease options.
Recently, the company was awarded an ISO 9001:2015 Certification, demonstrating its ability to provide services and products that consistently meet regulatory requirements.
Technical Safety Services (TSS) is one of the largest controlled room testing and certification firms in the US. Founded in 1970, TSS has the authority of a company backed by 50 years of industry expertise.
Headquartered in San Diego, TSS serves more than a dozen states, with over 400 capable employees.
TSS is ISO 9001:2015 Certified and a proud member of the National Conference of Standards Laboratories. They’re also accredited by the ANSI National Accreditation Board (ANAB) and NSF.
To ensure clients get the most out of their investment, TSS field technicians receive ongoing training through its very own institute to meet the proficiency demanded by the job.
What Should You Look For In a Cleanroom Certification Company?
A cleanroom certification guarantees your workspace is safe and free from harmful contaminants. So, if you’re a facility manager, there are several factors you must consider when choosing a cleanroom certification company.
Accreditation and Certification
Pick a firm that’s recognized by industry bodies. Ideally, those that are accredited by the International Organization for Standardization (ISO), the National Environmental Balancing Bureau (NEBB), or any of the following:
- Institute of Environmental Sciences and Technologies (IEST)
- American Society for Testing and Materials (ASTM)
- The Cleanroom Testing and Certification Board International (CTCBI)
- Food and Drug Administration (FDA)
- National Sanitation Foundation (NSF)
- Controlled Environment Testing Association’s National Board of Testing (CNBT)
Staff Skills and Training
You want to hire a company with sufficiently trained personnel. They should have technical expertise, especially in standards imposed on controlled environments, particularly ISO 14644 or Federal Standard 209E.
In most cases, we’d recommend looking for a cleanroom validation company specializing in your particular sector.
Services and Customizations
Find a firm that offers the full range of services you may need. At the very least, they must provide testing, validation, and certification for air quality, pressure, temperature, humidity, climate control, and other crucial cleanroom aspects.
Of course, not every facility needs the highest ISO clearance. So, the company must be capable of tailoring the testing procedures to match your use of the controlled space.
Documentation and Customer Support
Documentation is vital in controlled-environment certification, as it verifies that your cleanroom adheres to the regulations. These records must include everything from test results and system design to cleaning schedules and maintenance intervals.
Of course, don’t forget the company’s customer support. They should be transparent and responsive to inquiries about their procedures or rates.
Final Thoughts
Cleanrooms are indispensable to many modern technologies. From the screen you’re reading this on to the cold medicine you just took, almost everywhere you’ll find products that wouldn’t have been possible without controlled environments.
That’s why businesses and companies must have cleanrooms that have been certified to comply with the cleanliness and operational guidelines outlined by the experts.