Aseptics 3 Flashcards
What is Bioburden?
Limited number of microorganisms are still present in an object.
Explain the viable counting process.
Alive:
Active Metabolic Cell
Plasma Membrane is intact and metabolic activity is present.
Plasma Membrane intact but less RNA content.
Dead:
Plasma membrane is damaged.
DNA is damaged
Cell Fragments
Define sterility.
Concept of which very little microorganisms are present.
What is sterilisation?
Process by which sterility takes place.
Can use biocidal agents.
What is disinfection?
Process by which a reduction of microorganisms in an inanimate surface.
Can use disinfectant wipes/sprays.
What is a survivor curve?
What is the general relationship you expect to see on the survival curve?
State the general relationship between microbes and sensitivity levels.
What are the 5 processes of sterilisation?
What does sterility assurance level represent?
What is a D-value?
What is the general relationship between D-values and temperature?
How is D-value represented graphically?
Explain the trends between D-value and sterilisation methods.
What is Z-values?
What are performance verification tests?
Explain how the following indicators are used in performance verification tests:
a. Physical
b. Chemical
c. Biological
What is sterility testing?
What are the 2 different techniques used for sterility testing?
What type of medium is used for the sterility test?
Explain what happens if growth is/isn’t present.
Explain what Direct Inoculation is.
Explain what Membrane Filtration is.
What results do you expect to see in sterility testing?
Explain how much sterility testing is required to be tested.
Explain how much sample is needed to test.
What are pyrogens?
What are 2 types of pyrogens?
What is an endotoxin?
What effect does an endotoxin produce?
What is depyrogenation?
How are pyrogens removed?
How can pyrogens be destroyed?
What are the 3 types of pyrogen testing?
Explain the process of each type of pyrogen testing.
State the difference between LAL and rFC assay pyrogen testing.
Explain how endotoxin limits are used in practice.
What formula is used to represent endotoxin limits?