Share thisI received an e-mail from Rick Gastner, who has many years of experience certifying containment equipment and facilities including biosafety cabinets and cleanrooms, stating his agreement with the conclusions of a recent column but also stating that the issue of certification could be more directly discussed in upcoming columns. I agree and I have invited him to contribute to an upcoming column on the issues that are often faced when certifying equipment or a facility. The e-mail did get me thinking so I decided to share some initial thoughts on certification in this column.
Certification — confirmation that some fact or statement is true through the use of documentary evidence
In looking at this common diction definition of certification, one begins to understand the issues we have had with certification in the world of containment. The above definition implies with “fact” and “true” that an objective measurable condition is being met and being certified to. Some certifications in containment such as the certification of a Class II biosafety cabinet do have an objective measurable condition to meet such as NSF/ANSI Standard 49 Class II (laminar flow) Biosafety Cabinetry. This certification applies only to Class II biological safety cabinets, as designed. According to the National Sanitation Foundation (NSF) the standard defines the tests for which a cabinet must comply to become NSF Certified. It is interesting to note the “as designed” definition. The NSF certification applies only to the biosafety cabinet’s ability to perform in a certain way. As we are well aware, it does not mean that they will be installed or used in a safe manner, regardless of personnel practice.
It is also interesting that there is not a similar certification for Class III biosafety cabinets. Often this equipment is certified through a program under the leadership of the owner in consultation with the cabinet manufacturer, with the definition of performance for certification created on a case by case basis.
Biosafety cabinets are an example of certification based on objective measurable performance data. Another example of this type of certification is cleanroom certification. While there are numerous examples of certification requirements for cleanrooms such as Federal Standard 209 or the International Organization for Standardization, ISO 14644, what they have in common is an objective standard for each class of cleanroom that defines how many particles of what size are acceptable to measure by a specific methodology. The answer for certification is objective, true or false, pass or fail. Again, certification of a cleanroom certifies the facility only; it does not certify that it will be effective no matter how it is used.
In contrast, while many facets of containment facilities are objective, many are subjective, left open to interpretation and risk assessment. One can define containment barrier leak tightness objectively with pressure decay tests; however, experience has shown that most of the time this is not necessary. Subjective evaluation of the barrier is adequate utilizing smoke pencils, visual inspection, or other similar methods. In addition, as the principles used in the design of the facilities are guidelines based on risk assessment rather than proscriptive requirements that could be easily measured, much of the design and operations of a containment facility is subjective based on the judgment of the overall design team with the final say coming from the principle investigator in conjunction with his biosafety support team.