Biosafety
Cabinets
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 recirculated 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. ENV Services, Inc. is uniquely
qualified to execute a performance evaluation of your hood for certification,
troubleshooting, repairs or general evaluation.
When ENV tests and certifies
your contamination control equipment; such as a biosafety cabinet, you
can be sure it will perform to appropriate national standards or manufacturer
specifications. We have been testing, certifying, and maintaining contamination
control equipment for over 30 years.
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.
ENV 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, labor or full maintenance service agreements
provide a cost-effective solution to unanticipated maintenance requirements.
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