Welcome everybody to this series of modules on biorisk management. In this lesson we will be covering biosafety cabinet certification. This is the third lesson on biosafety cabinets. In the first lesson, we talked about what type of cabinets there are and how to select them. The second lesson was on how to use them properly and now we’re going to discuss their field certification.

This is one of the most important types of engineering controls we have in a biomedical facility. It’s a cabinet that will keep your products safe, keep you safe, and keep the environment safe. Because it is a machine, we can measure things that it’s supposed to do. Therefore, we can get readings from test equipment to make sure that is working correctly. This is the process of certification, which confirms the cabinet is performing the way the manufacturer intended.

Certification of biosafety cabinets is based upon standards. The National Sanitation Foundation (NSF) has established standard 49 that covers the design and the construction of biosafety cabinets. This way cabinet manufacturers know what they are supposed to be designing and constructing. It covers performance criteria, testing, certification and installation recommendations. In addition, it also provides recommendations on decontamination procedures, references and specifications. All cabinets that are certified and tested to these standards have the NSF seal. This gives you confidence when buying a cabinet that they have been built to a rigorous standard and tested for functionality. 

Based upon the NSF 49 standard, the manufacturer has to do some testing of the biosafety cabinet, as is shown here? They use bacillus subtilis spores to test for personal protection, inflow velocity, product protection and cross contamination within the cabinet. As you see, the manufacture has to do some rigorous testing to prove that the cabinet is meeting the NSF 49 standards and that it will meet your needs in the biomedical environment that you work in.

NSF 49 also requires some additional safety tests. These are stability or resistance to overturning, electrical, vibration, noise, drain spillage, motor performance and resistance to distortion or deflection. Resistance to distortion or deflection proves that it’s going to be sturdy and it’s not going to be twisted or broken in some way when moved. As you see the NSF standard provides a great baseline for manufactures to work from when building a BSC.

In addition to the NSF 49, there are a number of other BSC standards in the world. NSF 49 comes from the United States, but another one that is very popular and used around the world is the European Union standard EN12469. There are also Australian and Japanese standards. Different BSC manufacturers around the world may choose any one of these standards to base their cabinet design on. No one is necessarily better than another, they’re just all slightly different. Make sure that your cabinet certifier knows what standard the cabinet was manufactured to so that they can certify the BSC to that standard.

BSC testing and certification.

When is field certification required? First before initial use. Even though it comes from the manufacturer certified, a variety of things could happen to it in transit or a mistake occurs in manufacturing.  Second, after moving the biosafety cabinet. If you move it up and down different floors or from one room to another you may do some damage to it. Third, after a filter replacement. This is usually done by the certifier when they’re testing the cabinet, but if done by your own staff, the BSC must be recertified. Fourth, if there’s any internal cabinet repairs, such as a blower motor replacement, or a hole made in the cabinet, you should have it recertified. Finally, and most importantly the BSC should be recertified annually or on a regular basis based upon your risk assessment. If the cabinet is not used very often, maybe you can extend the certification to every two years. Or if it’s used very often and you want high assurance that the cabinet is working well, you may want to recertify every six months. After certification, the cabinet should be marked with the certification information somewhere on the outside of the cabinet. The certification sticker should indicate who did the work and when. The actual certification reports could be kept in the office with your logs. You need to keep a good record of each cabinet and when they were certified to prove that the cabinets are indeed working well.

Another important point to note about certification. Ensure that the person doing the certification is an accredited certifier. They should have some sort of documentation to show that they’ve had training and that they’ve been approved to actually do the work. You have the right to ask for their accreditation credentials. Here is an example of the credentials for an individual who was NSF accredited on a certain date and time. These people also need to be recertified on a regular basis. Therefore, make sure that they can prove to you that they are an accredited certifier and not just somebody who pretends to know what they’re doing.

In review, I just want to remind you that the purpose of field certification is to validate that the biosafety cabinets are performing to the standards specified by the manufacturer. Again, there’s no one standard that the BSC is being tested to. What the certification is proving, is that this piece of engineering equipment is working to the standard used by the manufacturer. 

It’s a precise science, using precise calibrated equipment done by a trained and certified person. Remember it’s not just somebody who pretends that they know what they’re doing with some equipment that they’ve bought somewhere. This is a precise science. You really want somebody using good equipment that knows what they’re doing to certify your cabinets.