Sterilisation Flashcards

1
Q

How do pathogens harm the patient?

A

Cause infectious disease

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2
Q

How do microbes damage a product?

A

Degrade API, make dose unpalatable

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3
Q

Which routes of administration have the greatest and least infection hazards?

A
  • Parenteral has the greatest risk
  • Then cream (skin is sensitive)
  • Oral has the least risk - stomach acid kills bacteria
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4
Q

Which order is microbe growth?

A

First order = logarithmic

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5
Q

What does CFU stand for?

A

Colony forming unit = 1 live microbe

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6
Q

What is Decimal Reduction Time (D)?

A

Time taken for a 10x reduction in microbes (i.e. 90% reduction in concentration)

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7
Q

What is the sterility assurance level (SAL)?

A
  • Level of sterility required for terminally sterilised products = 10-6
  • Therefore the probability of an item being non-sterile if selected at random should be 1 in 1,000,000
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8
Q

How is sterilisation time for an item decided?

A

Based on decimal kill rate (D) value

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9
Q

How is sterility tested?

A
  1. Take a sample from the item (swab, liquid or filtrate)
  2. Add to culture medium
  3. If no growth after 14 days = non-sterile
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10
Q

Define: Sterilsation

A

Totally killing all microbes on product/item

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11
Q

Define: Sanitisation

A

Cleaning a surface

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12
Q

What does a disinfectant do?

A

Kills microbes on a surface

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13
Q

What does an antiseptic do?

A

Kills microbes on skin/tissue

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14
Q

What does a microbicide do?

A

Kills microbes

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15
Q

What does a bacteriostatic drug do?

A

Stops growth of bacteria

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16
Q

List 2 methods by which heat is used as a sterilisation technique?

A
  1. Steam
  2. Dry heat
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17
Q

List 2 advantages of using heat as a sterilisation technique?

A
  1. Steam is very effective
  2. Cheap
18
Q

List disadvantages of using heat as a sterilisation technique?

A
  1. Wets product/dries product out
  2. Can damage product
19
Q

What application is there for using filtration as a sterilisation technique?

A

Solutions for injection

20
Q

List 2 advantages of using filtration as a sterilisation technique

A
  1. Good for liquids/solutions
  2. Removes particles
21
Q

List 2 disadvantages of using filtration as a sterilisation technique

A
  1. Only good for solutions
  2. Costly
22
Q

What application is there for using chemical sterilisation?

A

Surfaces and equipment

23
Q

List 2 advantages of chemical sterilisation

A
  1. Cheap
  2. Very effective
24
Q

List 2 disadvantages of chemical sterilisation

A
  1. Usually needs to be removed from the product afterwards
  2. May damage product
25
Q

List 2 examples of irradiation used for sterilisation

A
  1. Gamma
  2. UV
26
Q

List 2 appllications of where irradiation can be used as a sterilisation technique

A
  1. Surfaces
  2. Packed products
27
Q

List 2 advantages of irradiation as a sterilisation technique

A
  1. Quick and cheap
  2. Penetrates packet
28
Q

List 2 disadvantages of irradiation as a sterilisation technique

A
  1. Surface only
  2. Safety
29
Q

What is the disadvantage of using gas as a sterilisation technique?

A

Hazardous to workers

30
Q

What piece of equipment is used for steam sterilisation?

A

Autoclave

31
Q

What are the conditions within the autoclave?

A
  • 121°​C
  • High pressure
  • 15-30 minutes
32
Q

How does the autoclave/steam kill bacteria?

A

Hydrolyses the proteins

33
Q

What is dry heat sterilisation used for?

A
  • Typically for surgical instruments
  • Hot enough to char off some components
34
Q

What are the conditions of dry heat sterilisation?

A
  • 170°C
  • 2 hours
35
Q

Define: Terminal sterilisation

A

When the product is sterilised at the start and at the end

36
Q

Define: Non-terminal sterilisation

A

When product is sterilised throughout the manufacturing process

37
Q

List 3 chemicals used for sterilisation and how they work

A
  1. Phenols - disrupt membrane and denature proteins
  2. Alcohol - denature proteins and dissolve membranes
  3. Aldehydes - crosslinks biomolecules, one of the most effective disinfectants
38
Q

List 4 conditions which influence the effectiveness of antimicrobial agents

A
  1. Type of micro-organism
  2. Concentration of micro-organisms
  3. Environmental conditions (pH, viscosity)
  4. Temperature
39
Q

Which is harder to kill - gram negative or gram positive bacteria?

A

Gram negative

40
Q

List 2 other processes that occur during the production of sterile products

A
  1. Aseptic handling
  2. Quality control and monitoring