These challenges have resulted in struggles to maintain compliance and meet evolving regulations, reports Kyle Postmus, Senior Manager at NSF.
With increasing regulations in laboratory safety and biosafety requirements outlined in NSF/ANSI 49 — Design, Construction, Performance and Field Certification — field certifiers play a critical role by ensuring that any affected companies and organisations can meet the required standards.1
An accredited NSF Class II biosafety cabinet field certifier is either mandatory or highly recommended by many grants, universities, pharma, biotech, United States Penitentiary (USP) facilities and laboratories to test, repair, decontaminate and certify Class II biosafety cabinets.
Biosafety accreditation programme
NSF/ANSI 49 originated in the 1970s as a framework for biosafety standards. In the 1980s, responding to specific requests from the National Institute of Health (NIH), Center for Disease Control (CDC) and National Cancer Institute (NCI), NSF developed its biosafety accreditation programme.
This is still in use today and has been updated with time to ensure that the test meets the latest technology and industry needs.
The test includes evaluation criteria for hands-on testing, ethical operations and continued education across a wide range of biosafety cabinetry safety operations.
Conducted using both written and practical methods, the programme is used to accredit certifiers of Class II biosafety cabinets, including A1, A2, B1, B2 and C1 systems, which are commonly used in research labs and healthcare facilities.
The most common reasons for failure
The biosafety accreditation programme tests include multiple categories to verify that accredited field certifiers are well-versed in various aspects of biosafety cabinetry maintenance and safety.
Individuals are evaluated in categories including downflow velocity, high-efficiency particulate air (HEPA) filter leak scans, vibration tests and site installation assessments, to name a few.
To pass the biosafety accreditation programme, individuals must score at least 80% on the written exam, plus achieve passing scores on all 12 individual tests (90% on containment tests and 70% on worker comfort tests), which comprise the practical exam.
With many different testing categories, it is important that individuals properly study, prepare and equip themselves with the knowledge they need to pass the test the first time.
Although each section is important to understand thoroughly, there are a couple that represent the most common points of failure for accreditation candidates.
These include the airflow smoke pattern test, the HEPA filter leak test, the site installation test and the vibration test. Those who are testing may want to spend extra time focusing on these sections to prepare properly.
Airflow pattern test: Biosafety cabinets must have an airflow that is contained to avoid contamination.
To test this, a visible mist/fog is introduced into the biosafety cabinet to evaluate whether the airflow is flowing smoothly down through the work area, without reflux, away from the user and without billowing into the work area and not leaking out of the front opening.
Although candidates typically perform the test correctly, they often misinterpret the turbulence during the individual testing of the four airflow patterns, causing them to fail this section.
HEPA filter leak test (scan method): HEPA filters are critical to ensure the biosafety cabinet does not leak. Individuals are tested to confirm that the challenge test aerosol does not leak beyond 0.1% of the upstream concentration, indicating that the filter needs to be repaired or replaced.
During testing, candidates often make the mistake of scanning too close to the HEPA filter, which can cause scratches and lead to damage and/or leakage. Additionally, they may lack the skill or technique to distinguish leaks at the media and gasket.
Site installation test: Evaluating whether a biosafety cabinet is functioning correctly in situ is important to ensure that it meets industry standards. This is also done as part of recertification requirements; as such, certifiers must be well-versed in the testing requirements of this section.
During testing, candidates often inaccurately explain the procedure to check the exhaust alarms and supply blower interlock, which are critical to ensuring airflow control.
Vibration test: Labs constantly work with sensitive materials, making a stable and non-distracting workspace imperative to support both focus and precision.
The vibration test evaluates biosafety cabinets to ensure they do not exceed the vibration amplitude and frequency requirements. Typically, candidates are not knowledgeable about the workspace measurements, including whether the air intake grille is included, causing them to fail this section.
By understanding which areas of the test are most challenging for testers, applicants can prepare by knowing which sections to spend extra time on. Accredited biosafety cabinet field certifiers must have a deep knowledge about all aspects of the systems and their operations so they can confidently and accurately certify them for use.
Preparing for the accreditation test
NSF accreditation exams ensure that certification companies provide individuals with the knowledge and commitment (signed ethics statement) to provide a certification, thereby meeting NSF’s minimum requirements.
Properly maintained biosafety cabinets help to keep laboratory workers, products (pharmaceuticals for injection, blood and in vitro fertilisation (IVF) products, cell cultures, etc.), and the environment safe from contamination.
For candidates wanting to start the application process, it is important to have all the necessary documentation ready before starting. To qualify for application, a minimum of a high school diploma is required for the education portion.
Additionally, one year of prior experience performing biosafety cabinet performance testing is required. Candidates must be prepared with 20 test reports, five of which must specifically refer to B2 biosafety cabinets.
Lastly, they must complete the relevant application (Enhanced Biosafety Cabinet Field Certifier Accreditation for North American applicants and Basic Accreditation for those elsewhere).
Regardless of which test one applies for, passing is attainable if an applicant adequately prepares for it.
By being prepared with the correct documentation, studying and thoroughly understanding the different testing requirements, applicants can be more confident during the testing process.
It is important to field-certify biosafety cabinets to ensure they meet rigorous standard requirements. By servicing the machinery, the industry can continue to do its job while keeping individuals and wider communities safe.
Reference
- www.nsf.org/lab-testing/biosafety-cabinetry/biosafety-cabinet-certification.
