unit 2 - sterile manufacturing 2 - clean rooms Flashcards
What is a cleanroom?
Special manufacturing facilities with control over the levels of contamination
- viable
- non-viable
How are cleanrooms classified?
By the cleanliness of their air
FS-209
- number of particles equal to or greater than 0.5 um is measured in one cubic foot of air
- this count is used to classify the room
FS-209E
- metric conversion
- logarithm of the airborne concentration of particles equal to or greater than 0.5 um in one cubic metre
What is the definition of a clean room?
A room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimise the introduction, generation and retention of particles inside the room and in which other relevant parameters
- temperature
- powder flow
- humidity
- sticking of powder
- pressure
are controlled as necessary
What are the three classifications of cleanrooms?
Classification level dependent upon the room’s activity and use
- an empty room will have a low particulate load
As built
- empty of all equipment
With equipment but no personnel
Fully operational
Give four methods to organism monitoring
Air sampling
- slit air samplers
Settle plates
- agar exposed to atmospheric air
Contact plates
- agar plates wiped on surface of units
Finger dabs
- glove testing
What is a slit air sampler?
Device which sucks air from room and passes it over an agar plate
Give examples of types of cleanroom areas
Conventional
Unidirectional
- laminar
Mixed flow
Isolators
Give two examples of cleanroom air flow
Conventional cleanrooms
- turbulently ventilated cleanrooms
- non-unidirectional air flow cleanrooms
Unidirectional flow cleanrooms
- laminar flow cleanrooms
- ultra cleanrooms
What is the difference between air conditioning in offices through ceiling diffusers and conventional cleanrooms?
Increased air supply
- normal office = 10 air changes/hour
- cleanroom = 20 - 60 air changes/hour
High Efficiency Particle Air (HEPA) filter
- >99.97% removal of particles > 0.3 um
Rooms are pressurised to keep dirty air out
- held back when door/window is open
Rooms constructed of materials which do not generate particles, and are easy to clean
What is the function of conventional cleanroom dependent on?
May achieve class 1,000 but more likely to be class 10,000
Totally dependent upon total volume of air supplied and the number of particles generated by equipment and operators
What are unidirectional cleanrooms?
Flow of air is in one direction either vertical or horizontal at a uniform speed of between 0.3 - 0.45 m/s throughout the entire air space
- too fast = turbulence
Why are vertical unidirectional flow cleanrooms more efficient?
No vortices so no turbulence
What technological advances have been made with cleanrooms?
Isolators
- positive
- negative
Originally used in nuclear industry
Protect product and operator from each other
High risk products
- cytotoxics
- BSE
- gene therapy
What is particulate air filtration?
The arrangement of spacing of the filters together with the velocity of air passing through, affects both the concentration of airborne particulate material and the formation of turbulent zones and pathways within the room
Remove particles and direct airflow
- unidirectional flow
How are HEPA filters made?
Aim to generate a large surface area of filter paper in a frame from which there are no leakages of unfiltered air
HEPA filters based on traditional construction with aluminium foil separator
Rated by efficiency to remove 99.97% of 0.3um particles at an air flow rate of 1.5 to 2.2cm/s
