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Sterilisation Flashcards

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1
Q

What does SAL stand for and what is it?

A

Sterility assurance level, it’s a probability of how much contamination in a batch

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2
Q

What does PNSU stand for?

A

Probability of a non sterile unit

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3
Q

What’s the definition of sterile?

A

Free from all viable forms of life BUT negative state is hard to prove, can we detect all viable forms, sterilisation process not effective for all organisms.

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4
Q

Sterilisation proceeds like a what order reaction?

A

First order

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5
Q

What two disadvantages of a long sterilisation process?

A

1) drug may degrade

2) expensive

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6
Q

What’s the minimum required standard for most pharmaceutical products?

A

PNSU of 1 in 10^6

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7
Q

Why do fungi form spores?

A

Reproduction

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8
Q

Why do bacteria form spores?

A

For survival

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9
Q

Which type of bacteria has a thin layer of peptidoglycan?

A

Gram negative

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10
Q

Which type of bacteria have teichoic and lipteichoic acids?

A

Gram positive

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11
Q

Which type of bacteria has so membranes and LPS

A

Gram negative

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12
Q

Sporulation occurs during which phase?

A

Stationary phase

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13
Q

Do fungi make peptidoglycan?

A

NO

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14
Q

Name 5 different types of water in industry

A

1) potable mains water
2) softened water
3) de-ionised water
4) distilled water
5) reverse osmosis

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15
Q

List 3 ways to treat water

A

1) chemical: hypochlorite + chlorine has
2) filtration
3) UV-light

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16
Q

What’s the D-Value

A

The time taken to achieve 1 log (90%) reduction in no.viable cells e.g D121 = time at 121degrees C it takes to give 1 log reduction in surviving fraction

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17
Q

The higher the D value the what the resistance

A

Greater

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18
Q

What’s the Z value?

A

The temp change required to give a 10 fold change in the D value

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19
Q

Name 3 high level disinfectants

A

1) aldehydes
2) hypochlorites
3) peroxydens

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20
Q

Name 5 intermediate disinfectants

A

1) alcohols
2) biguanides
3) ioddine/iodophore
4) phenolics
5) QACs

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21
Q

Name one low level disinfectant

A

Phenolics

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22
Q

What two environmental factors affect choice of disinfectant?

A

1) organic matter- blood eg can decrease antimicrobial capacity
2) divalent cations- block disinfectant adsorption sites

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23
Q

What’s the temperature coefficient

A

Q10

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24
Q

Name the process of the suspension test

A

1) dilutions of disinfectant added to standardised bacterial suspension in water + albumin at set temp
2) remove sample
3) neutralise disinfectant
4) determine viable count

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25
Q

What don’t alcohol gels kill?

A

C.diff spores or noravirus

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26
Q

Name two most likely contaminants of eye products

A

1) pseudomonas aeruginosa

2) staphylococcus aureus

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27
Q

Name 2 organic acids used as agents

A

Benzoic acid

Sorbic acid

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28
Q

What do you need to consider with organic acid and esters as agents?

A

pKa

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29
Q

Name an organic ester used as an agent

A

P-hydroxybenzoic acid

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30
Q

At what percent are alcohol agents bactericidal

A

> 50%

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31
Q

Are aliphatic alcohol agents sporicidal?

A

NO

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32
Q

Name 3 aromatic alcohols used as agents

A

Benzyl alcohol
Phenylethanol
Phenoxyethanol

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33
Q

Name three classes of alcohols used as agents

A

Aliphatic
Aromatic
Substituted

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34
Q

What’s the disadvantage of chlorbutol and bronopol (substituted alcohols) as agents

A

Unstable and not sporicidal

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35
Q

Name 3 disadvantages of aldehydes used as agents

A

Activity decreased by polymerisation
Toxic
Carcinogenic

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36
Q

Name the more active aldehyde agent and it’s concentration

A

OPA- ortho-phthalaldehyde 0.5%

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37
Q

What’s the disadvantage of biguanides as agents

A

Activity decreased by anionic compounds e.g soups, and also by organic matter

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38
Q

What do you have to do with the halogen agents hypochlorites daily?

A

Dilute to in-use conc due to instability

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39
Q

Name 3 types of phenolic tar acids

A

Cresol
Xylenols
Ethyl phenols

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40
Q

Name 3 ways antimicrobials can affect the cell wall

A

1) breakdown cell wall
2) affect integrity of outer membrane
3) X-link cell wall

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41
Q

Name a powerful oxidative agent for destruction that undergoes chemical oxidation

A

Chromic acid

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42
Q

Name three types of sterilisation processes

A

Destruction
Killing/inactivation
Removal

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43
Q

Name 5 sterilisation processes in the European pharmacopoeia

A

1) steam sterilisation
2) dry heat
3) ionising radiation
4) gaseous sterilisation
5) filtration

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44
Q

Moist heat sterilisation involves what temperature

A

121-134

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45
Q

Name 2 products used in gaseous sterilisation

A

Ethylene oxide or formaldehyde

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46
Q

Dry heat sterilisation uses what temp?

A

160-180

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47
Q

Sterilisation processes have a compromise between what two things

A

Good antimicrobials activity and product stability

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48
Q

What’s an autoclave

A

Like a pressure cooking but more than 100 degrees, high pressure, organisms killed by temp, hydration and time

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49
Q

What is superheated steam?

A

Is water in the vapour phase and behaves like a gas, decrease temp decrease pressure

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50
Q

What is supersaturated steam

A

Also known as wet steam, is in liquid phase and is made up of small droplets of water held in suspension by convection currents

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51
Q

What is dry saturated steam?

A

Exists only on the phase boundary, if you lower the temp it will condense

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52
Q

Name three types of steam

A

Superheated steam
Supersaturated steam
Dry saturated steam

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53
Q

What type of steam is suitable for sterilisation

A

Dry saturated steam

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54
Q

Name three ways in which dry saturated steam works in sterilisation

A

Heat
Hydration
Penetration

55
Q

What is sensible heat

A

As it’s released it results in a change of temp

56
Q

What is latent heat?

A

As released results in change of state not temp e.g ice to liquid

57
Q

Why is dry saturable steam more penetrable than superheated steam?

A

Upon condensation volume contracts >800 times this creates a local vacuum drawing in more steam

58
Q

Name two large scale autoclave sterilisers

A

Gravity displacement autoclave

Porous load autoclave (vacuum assisted)

59
Q

What is necessary on a large scale autoclave in order to maintain even heat distribution?

A

Heated outer jacket

60
Q

Is a porous load vacuum assisted?

A

YEH MAN

61
Q

Name the three stages if operation for large scale porous load autoclaving

A

1) air removal and steam admission
2) heating up and exposure
3) drying and cooling

62
Q

There’s two main problems with autoclaving what are they

A

Air in autoclave

Superheated steam

63
Q

Using dry heat sterilisation, inactivation is principally by what

A

Oxidation

64
Q

What does LTSF stand for

A

Low temp steam formaldehyde- 37% aqueous solution formalin with steam

65
Q

In formaldehyde gas sterilisation how is the formaldehyde released

A

By vaporisation from formalin

66
Q

What temp and gas is required in formaldehyde gas sterilisation

A

Temp 70-75degrees

Gas 15-100mg/l

67
Q

Name four types of radiation sterilisation

A

Gamma rays
Electron beams
X rays
Uv light

68
Q

Dose of radiation specified by BP is what

A

25kGy

69
Q

Name 4 materials used for filtration

A

Polyether sulfone (PES)
Cellulose acetate (CA)
Nylon
Polytetrafluorethylene (PTFE)

70
Q

What does the BP limit the filtration time to and why

A

4hours due to bacteria dividing and growing on filter

71
Q

What is a biological indicator usually used for

A

Validating method not as a routine control indicator

72
Q

Explain the process of a attest biological indicator

A

After sterilisation, inner ampoules is crushed and tube inoculated at 55degrees
Fail= yellow
Pass= purple

73
Q

Name three pyrogens tests

A

Rabbit pyrogen tests (RPT)
Limulus amoebicyte lysate (LAL)
Monocyte activation tests (MAT)

74
Q

Name a physical indicator for testing filtration

A

Bubble point pressure test

75
Q

Name a physical indicator for radiation

A

Plastic dosimeter darkens in proportion to radiation

76
Q

Name a physical indicator to test gas sterilisation

A

Leak tests, pressure testing

77
Q

Name the three ways autoclaves kill organisms

A

Temperature
Hydration
Time

78
Q

Name three factors playing a role in why dry saturated steam is used in sterilisation

A

Heat
Hydration
Penetration

79
Q

What is sensible heat

A

When exchanged = change of temp

80
Q

What is latent heat

A

When exchanged results in change of state NOT TEMP

81
Q

Supersaturated steam releases what type of heat?

A

Has no latent heat will release only sensible

82
Q

What type of heat does superheated steam release?

A

Has both sensible and latent heat but in absence of condensation will release only sensible heat

83
Q

What type of heat does dry saturated steam release?

A

Both sensible and latent

84
Q

Can bench autoclaves suffer from superheating?

A

No cos there’s water in the vessel itself, increase temp more steam is produced both temp and pressure increase so steam remains in boundary phase #nobiggy

85
Q

Name two large scale autoclaves

A

Gravity displacement autoclave

Porous load autoclave (vacuum assisted)

86
Q

Is a porous load autoclave vacuum assisted?

A

You betcha

87
Q

What does a large scale autoclaves have that bench don’t?

A

Separate external/internal steam generator

88
Q

Which have shorter cycle times bench or large scale autoclaves and why

A

Large scale cos the steam is available immediately due to separate steam generator

89
Q

Do large scale autoclaves wear clothes

A

Yh heated outer jacket ?

90
Q

In large scale autoclaving how do you prevent bursting of products

A

Air ballasting, to prevent layering of this maintained air you may require a fan or spraying mechanism

91
Q

How does dry heat sterilisation work

A

Oxidation

92
Q

Name two instruments that can be used for dry heat sterilisation

A

Hot air oven

Dry heat steriliser tunnel

93
Q

What are the 3 key disadvantages of dry heat sterilisation

A

Long time to heat up
Temp must be higher and longer
Large temp variations in load

94
Q

What are 3 disadvantages of gas sterilisation

A

Slow
Toxic
Gas may be absorbed

95
Q

What’s the boiling point of ethylene oxide?

A

11 degree C

96
Q

Ethylene oxide sterilisation a required carefully controlled humidity .. Why?

A

Cos organisms in dried state are more resistant

97
Q

What should you do with products sterilised by gaseous sterilisation after?

A

On open shelf for days

In forced aeration cabinet (2-24hrs)

98
Q

What are the two types of mechanisms for filtration

A

Dead end filtration

Cross flow filtration

99
Q

Two disadvantages of filtration

A

Grow through

Breakthrough

100
Q

Quality control involves what

A

Testing of final product

101
Q

Quality assurance involves what

A

Assure that all stages of manufacturing processes contribute to the quality of the end product

102
Q

Name three types of validation and control

A

Environmental control
Control of sterilisation process
Control of the final product

103
Q

What does GMP stand for?

A

Good manufacturing practice (orange book)

104
Q

In a clean room what type of air filter is used

A

HEPA

105
Q

Are sinks allowed in grade A/B area?

A

No no

106
Q

What two pieces of equipment do you have in a grade A clean room

A

Laminar flow cabinets

Isolator

107
Q

What’s a benefit of a laminar flow cabinet

A

Repetitive strain injury less likely

108
Q

When would you use vertical laminar flow cabinets over horizontal

A

When dealing with hazardous substances ????

109
Q

Where would you ? vertical laminar flow cabinets

A

In a separate room away from any draughts, grade B

110
Q

Name two types of flow in laminar flow cabinets

A

Horizontal

Vertical

111
Q

Name two types of flow in isolators

A

Turbulent

Unidirectional

112
Q

Name some benefits of isolators

A

Cheaper to run
Disturbances in air flow not critical
Better for operator protection (-ve pressure)
Minimum operational parameters

113
Q

What type of pressure does a type 1 isolator have

A

Positive

114
Q

What type of pressure does a type 2 isolator have

A

Negative

115
Q

Which type of pressure in an isolator is less prone to leaks

A

Positive

116
Q

Name the two types of film you can have in an isolator

A

Rigid

Flexible

117
Q

Flexible film is only suitable in what pressure

A

Positive

118
Q

What’s a benefit of using flexible film in an isolator

A

Offers less limited workspace

119
Q

In sterility testing what type of fluid do you use for anaerobic organisms

A

Thioglycollate medium

120
Q

In sterility testing what type of medium do you use for aerobic bacteria and fungi

A

Soya bean casein digest medium

121
Q

List 5 controls in sterility testing

A 
Test media for sterility 
Test media for nutritive support 
Validation test (neutralise anti microbe)
Environmental monitoring 
Operator technique test
122
Q

List 5 modes of action of agents

A 
Cell wall
Cell membrane
Cytoplasm
Nucleoid
Ribosomes
123
Q

Name the two types of resistance

A

Intrinsic/innate

Extrinsic/acquired (phenotypic or genotypic)

124
Q

List 3 ways biofilms are such a problem

A

Resistant to antibiotics
Resistant to biocides
Difficult to phagocytose by immune

125
Q

What are the main type of bacteria that form spores

A

Gram positive

126
Q

What do fungi look like

A

Eukaryotes, cell wall containing polymeric sugars

127
Q

Name 3 types of fungi

A

Yeast
Multicellular filamentous moulds
Macroscopic filamentous fungi

128
Q

How do moulds grow

A

Masses of overlapping and interlinking hyphal filaments

129
Q

Are yeasts single cells?

A

SHYEH

130
Q

What are Protozoa

A

Diverse group of single celled animal like eukaryotes

131
Q

Do Protozoa have cell walls

A

No no boi

132
Q

Do Protozoa survive drying well?

A

No cos no cell wall unless in form of cysts

133
Q

What 2 things can infection from prions lead to

A

CJD

BSE

Microbiology (2 decks)

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