Laminar Flow Cabinets and Clean Rooms Flashcards
What is HEPA filtration?
high efficiency particulate air (HEPA) filtration is a process that filters microorganisms and particulates out while providing sufficient airflow to sweep aerosols and particulates out of the work area
What are the different components of a HEPA filter?
- medium (cellulose/fiberglass), separators, frame, adhesive to seal medium to frame and gasket to seal frame to cabinet
What is the HEPA filter capable of removing?
capable of removing 99.97% of all particulates 0.3 um diameter or larger
How does the HEPA filter work to remove microorganisms?
HEPA filtration directs the air in a uniform parallel flow and the rate of flow must be 24 m/minute
- these conditions maintain the work surface free from particulates and microorganisms but not perceptible to the operator and will not disrupt the procedures being performed on the work surface
- the work surface needs to be wiped down with a disinfectant solution using a non-shedding cloth
What is the purpose of the chemical fume hood?
protects the operator from gasses and vapours
- it does not protect the product or the environment from particulate contamination
What is the purpose of a laminar flow clean bench?
- it provides the product with protection from particulate contamination
- not operator protection as the air flows toward the operator and no protection for the environment
- should not be used for infectious or toxic particulates or activities possibly generating aerosols
What is the purpose of a biological safety cabinet?
- offers protection for the product from particulate contamination
- protects operator and environment
- useful for handling infectious or toxic particulate material or aerosols
What is a class 1 biological safety cabinet?
class 1 are partial containment cabinets which draw room air directly in from the front and exhausts this air through a HEPA filter
- the operator and the environment are protected from particulate exposure but not the product
- useful for handling infectious particulate or aerosol material
- should not be used to handle toxic vapours or gasses as these will pass through the HEPA filter and enter the environment
What is the class 2 biological safety cabinet?
- ## partial cabinets which protect the product, operator and environment from contamination
What is the difference between a type A and a type B BSC?
Type A: exhaust into the room
Type B: exhaust to the outside
(for all of these cabinets the exhausted air is passes through a HEPA filter)
What does a barrier isolator do? What does it look like?
Provides a physical barrier between a worker and a work process
- pretty much a large glove box with a sterile interior
- supplies and material are passes through an airlock system
What is the greatest source of contamination during aseptic preparation of drugs? What can be done about this?
- people are the greatest source of contamination during aseptic preparation of drugs, reducing personnel in the work space can ensure that product sterility will be maintained
Isolators are found in some hospital pharmacies to comply with USP 797 as an alternative to a _____
clean room
What is a clean room? What is it used for?
- it is used for some processes where particulate level needs to be controlled
- the entire ceiling or one wall is composed of HEPA filter panels with an air flow of bout 24 m/minute
- have been classified by allowable number of particles of size 0.5 um of larger per cubic foot of air
What are the 3 classes of rooms that are recognized?
class 100, class 10,000 and class 100,000 (class 100 means that the room may not have particle counts exceeding 100 particles of size 0.5 um per cubic foot)
