Biological Safety Cabinet Certification
We service and certify all types of Biological Safety Cabinets (BSC). Do you have a Class I, Class II, Type A1, A2, B1, B2, or a Class III device? If you are not sure what type of cabinet you have, give us a call and we will let you know!
The standard BSC hood certification includes air velocity testing to document and obtain an acceptable airflow and calculated total CFM volume, meeting the manufacturer’s specifications. The HEPA filter integrity test is also performed to document acceptable performance of no leakage in excess of .01% of the upstream challenge concentration.
Additional testing includes: airflow smoke test, sound level testing, florescent light testing, ultra-violet light testing, electrical testing, vibration testing, cabinet leak testing, particle count classification and temperature testing. Decontamination's are also performed as requested or required for internal maintenance.
All reporting is printed out electronically on-site via computer, and a compliance certificate is issued and applied to the unit denoting test date, status, and re-certification due date.
The standard used by LCGC LABS to certify the hood's performance is the NSF 49 and EN12469 document on Class II (Laminar Flow) Bio-hazard Cabinetry, as well as the manufacturer's guidelines.
There are three main classes of Biological Safety Cabinets (BSCs).
Class I BSC provides personnel and environmental protection. It usually has an opening in the front below a sash where you can work with biohazards. Room air is drawn past the operator, past the product, and is exhausted through a HEPA filter to a dedicated exhaust duct.
Class II BSC provides personnel, product and environmental protection. This is the most common type of BSC. It has an opening in the front where you reach in and work with the product like a Class I BSC. Unlike a Class I BSC, HEPA filtered air is supplied to the work area inside the hood allowing the BSC to provide product protection. Not only is the worker protected from the product, the product is protected from the worker. There are four types of Class II BSC that are differentiated in whether or not the exhaust air is vented to the room or ducted outside the building and how much air is re-circulated within the BSC.
Class III BSC provides the highest level of personnel protection of the three classes of BSCs. A Class III BSC is a totally enclosed unit where access to the product is afforded by gloves attached to gloveports. When people refer to biological safety cabinets, they normally mean a Class II BSC. Most Class II BSC manufacturers recommend certification at least once a year. NSF International supports a consensus standard (Standard 49) addressing Class II BSC design, construction, and performance, which recommends certification at least annually. Different types of users may need to meet industry or regulatory certification requirements. The Joint Council of Accredited Hospital Organizations (JCAHO) recommends certifications at least annually for BSCs used in health care organizations. Some State Boards of Pharmacy recommend or require semi-annual certification. For pharmaceutical applications under FDA jurisdiction BSCs tend to be certified semi-annually.
NSF International’s Standard 49 recommends five containment tests for field certifications: downflow velocity profile test; inflow velocity test; airflow smoke patterns; HEPA filter leak test; and a cabinet leak test (when a cabinet is newly installed, relocated, or after panels were removed during maintenance procedures). The four worker comfort and safety tests recommended by NSF International are: electrical leakage, ground circuit resistance and polarity test; lighting intensity test; vibration test; and noise level test. In addition, NSF now requires a site installation assessment test for ducted units. This test determines that the duct system is being operated under negative pressure, and that the alarm system (if present) is operating properly.
Class II BSCs are an important part of a biosafety program. With proper maintenance and service they can provide protection for many years. LCGC LABS is uniquely qualified to execute a performance evaluation of your hood for certification, troubleshooting, repairs or general evaluation. When LCGC LABS tests and certifies your contamination control equipment; such as a biosafety cabinet, you can be sure it will perform to appropriate required standards or manufacturer specifications.
We provide these services to the wide range of industries that use this equipment for research and production activities, including the pharmaceutical, health care, biomedical research, chemical, and biotechnology industries.
LCGC LABS performs service on an as-needed or service agreement basis. Service agreements are designed to meet your needs. For clients who have fixed budgets or just want peace of mind, our certification, labour or full maintenance service agreements provide a cost-effective solution to unanticipated maintenance requirements.