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PA EE2 > Aseptics 3 > Flashcards

Aseptics 3 Flashcards

1
Q

What is Bioburden?

A

Limited number of microorganisms are still present in an object.

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2
Q

Explain the viable counting process.

A

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

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3
Q

Define sterility.

A

Concept of which very little microorganisms are present.

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4
Q

What is sterilisation?

A

Process by which sterility takes place.
Can use biocidal agents.

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5
Q

What is disinfection?

A

Process by which a reduction of microorganisms in an inanimate surface.
Can use disinfectant wipes/sprays.

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6
Q

What is a survivor curve?

A
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7
Q

What is the general relationship you expect to see on the survival curve?

A
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8
Q

State the general relationship between microbes and sensitivity levels.

A
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9
Q

What are the 5 processes of sterilisation?

A
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10
Q

What does sterility assurance level represent?

A
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11
Q

What is a D-value?

A
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12
Q

What is the general relationship between D-values and temperature?

A
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13
Q

How is D-value represented graphically?

A
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14
Q

Explain the trends between D-value and sterilisation methods.

A
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15
Q

What is Z-values?

A
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16
Q

What are performance verification tests?

A
17
Q

Explain how the following indicators are used in performance verification tests:
a. Physical
b. Chemical
c. Biological

A
18
Q

What is sterility testing?

A
19
Q

What are the 2 different techniques used for sterility testing?

A
20
Q

What type of medium is used for the sterility test?

A
21
Q

Explain what happens if growth is/isn’t present.

A
22
Q

Explain what Direct Inoculation is.

A
23
Q

Explain what Membrane Filtration is.

A
24
Q

What results do you expect to see in sterility testing?

A
25
Q

Explain how much sterility testing is required to be tested.

A
26
Q

Explain how much sample is needed to test.

A
27
Q

What are pyrogens?

A
28
Q

What are 2 types of pyrogens?

A
29
Q

What is an endotoxin?

A
30
Q

What effect does an endotoxin produce?

A
31
Q

What is depyrogenation?

A
32
Q

How are pyrogens removed?

A
33
Q

How can pyrogens be destroyed?

A
34
Q

What are the 3 types of pyrogen testing?

A
35
Q

Explain the process of each type of pyrogen testing.

A
36
Q

State the difference between LAL and rFC assay pyrogen testing.

A
37
Q

Explain how endotoxin limits are used in practice.

A
38
Q

What formula is used to represent endotoxin limits?

A

PA EE2 (26 decks)

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