Laboratory and Controlled Environment Certification & Testing Services

When your facility needs testing and certification, look no further than Technical Safety Services. We’re the national experts specializing in controlled environment and laboratory performance testing. We proudly serve clients in the life sciences and healthcare marketplaces.

From our superior support of research institutions, to the premier service we offer the biotechnology, pharmaceutical, healthcare and medical device industries - TSS is the recognized testing and certification leader. We have you covered when it comes to testing and certifying cleanrooms, controlled environments and mission critical equipment. We’re your one-stop resource for laboratory performance testing and cleanroom certification services.

Why Are Testing and Certification Services Important?

Testing and certification services are essential in the life sciences and healthcare industries because of the impact facilities and systems can have on the finished product and personnel safety. From cleanrooms to biological safety cabinets to compressed air systems, every element inside a laboratory or controlled environment must be trusted to perform as required. Our testing and certification services provide our clients with all the necessary expertise and experience they need to have peace of mind. 

For example, Class II biological safety cabinet testing and certification is critical not only for ensuring personnel protection, but to also ensure product protection and environmental protection. Our services include measuring the inflow and downflow of the airflow system, performing HEPA filter leak testing, testing alarms for proper function and other critical tests to verify the unit functions as designed.  

Choosing TSS to provide your facility with this or any other testing and certification service is crucial for meeting your facilities needs and ensuring the highest-quality results. Without our expert assistance, there’s a significantly higher risk of inspection failures, product defects and potential exposure to hazards. Any one of these can have a seriously negative impact on safety of staff, reputation of the business and profitability of your operations. This is why so many laboratories and cleanroom facilities across numerous industries have turned to us — because they know they can trust our services to deliver the highest levels of confidence and quality expectations. 

With an ISO 9001 certified quality system and nationwide network of skilled technicians, Technical Safety Services is uniquely positioned to ensure your operation remains productive and in compliance with regulatory standards. We want to be your trusted cleanroom and laboratory certification company: reliable, efficient and knowledgeable. We take pride in our ability to help our customers stay on top of their responsibilities so they can be sure they’re providing the best products. 

When you require the highest quality, best service and most dependable support, there is only one call to make. Make us your cleanroom and laboratory certification services provider.

Frequently Asked Questions

How does TSS perform biosafety cabinet certification, and what airflow measurements are included?

Our biosafety cabinet certification process includes testing for inflow velocity, downflow velocity, HEPA filter integrity, and airflow smoke visualization. Testing is performed in accordance with NSF/ANSI 49 and applicable manufacturer specifications.

What is involved in verifying HEPA filter integrity, and how often must it be retested?

Using aerosol challenge testing, our technicians identify leaks or defects in HEPA filters. Testing is typically performed annually, after filter replacement, or following maintenance or system changes, in accordance with applicable standards and facility requirements.

When certifying cleanrooms, which ISO classes and particle counts does TSS test against?

Our cleanroom testing references ISO 14644-1 classifications, including particle concentration limits at relevant sizes such as 0.5 μm and 5.0 μm.  For pharmaceutical and regulated environments, testing is performed in alignment with cGMP expectations.

How does TSS conduct fume hood performance testing (e.g., ASHRAE 110) and what acceptance criteria are used?

We perform fume hood performance testing using ASHRAE 110 tracer gas containment methods and airflow measurements. Acceptance criteria are based on the specific test method, hood design, and applicable facility or regulatory requirements.

What steps are taken for compressed dry air (CDA) or compressed gas system testing?

TSS performs comprehensive compressed dry air (CDA) and gas system testing based on applicable ISO, medical, and regulatory requirements. Testing may include nonviable particulate analysis, dew point (moisture) measurement, total oil (hydrocarbon) content, viable bioburden sampling, and purity verification. Our testing programs align with standards such as ISO 8573, ISO 14644, ISO 14698, USP, CGA, NFPA, medical gas specifications, military requirements, or custom client-defined criteria, depending on the application and risk profile of the system.

In airflow visualization studies, what tracer gas or smoke methods does TSS use to identify airflow patterns?

TSS conducts airflow visualization studies by primarily using near-neutrally buoyant visual media to ensure accurate representation of airflow behavior without artificially influencing flow patterns. We employ both small-scale and large-scale smoke generation equipment to evaluate airflow direction, uniformity, turbulence, backflow, and containment performance. To enhance clarity and interpretability, our technicians use specialized lighting, and contrast techniques to improve visibility of smoke patterns. USP-grade vegetable glycerin and propylene glycol are our primary visualization mediums, selected for their consistency, safety, and effectiveness in controlled environments. Other visual medium options are available upon request.

What documentation is delivered after testing, and how does TSS ensure it meets regulatory or customer audit requirements?

TSS provides detailed test reports, certification documentation, labels, and calibration records designed to support client audits and inspections under cGMP, GLP, or customer-specific requirements.

How does TSS integrate environmental monitoring data with testing and certification services?

Through optional services such as viable air sampling and surface monitoring, environmental monitoring data can be correlated with cleanroom performance testing to provide a more comprehensive view of facility conditions.

Which industry or regulatory standards guide TSS’s certification processes?

We adhere to recognized standards including NSF/ANSI 49, ISO 14644, IEST recommended practices, USP General Chapters, ASHRAE 110, cGMP requirements, and NIH/CDC BMBL guidance, as applicable.

Can TSS certifications be used to support compliance with audits from agencies like the FDA or NIH?

Yes, our testing documentation is designed to support regulatory and institutional audits and may be used as objective evidence during inspections.

What is the calibration schedule and quality control procedure for TSS’s measurement instruments used in tests?

TSS maintains a rigorous, ISO/IEC 17025:2017–accredited calibration and quality control program for all measurement instruments used in testing and certification services. Instruments are calibrated at defined intervals based on manufacturer recommendations, usage, stability, and risk, with all calibrations traceable to national or international standards. Calibration status is verified prior to use, and quality control checks are performed to ensure instruments remain within acceptable tolerances. All calibration and quality records are documented and maintained to support data integrity, audit readiness, and consistent measurement performance.

How does TSS handle non-conformance or out-of-spec results, and what remediation steps are offered?

Any out-of-specification results are documented and communicated to the client, along with recommended corrective actions such as repairs, adjustments, or retesting.

Does TSS offer retesting or interim verification services between full certification cycles?

Yes, we can schedule interim testing after any system modifications, suspected contamination, or client audits.

What quality management and accreditation systems does TSS maintain to ensure consistency and reliability of results?

Technical Safety Services operates under a robust, independently accredited quality system to ensure the accuracy, reliability, and defensibility of our results. TSS is ISO 9001 certified through Bureau Veritas and NEMKO. TSS is a member of the National Conference of Standards Laboratories (NCSL) and maintains an ISO/IEC 17025:2017–compliant metrology system. TSS is also accredited by the ANSI National Accreditation Board (ANAB) as an ISO/IEC 17025:2017 accredited testing laboratory. These accreditations support the technical competence of our measurement systems, calibration programs, and testing laboratories used in support of certification and compliance services. Call 866-598-4228 or CONTACT TSS online today.

 

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