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Y2S1 302 > 2: Sterilization > Flashcards

2: Sterilization Flashcards

1
Q

define sterility

A

absence of viable microorganisms

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2
Q

define aseptic processing

A

operations performed between sterilization of an object or preparation and final sealing of package
Carried out in complete absence of microorganisms

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3
Q

number of viable microorganisms in or on an object or preparation entering a sterilization step

A

bioburden

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4
Q

act of verifying that a procedure is capable of producing the intended result under all expected circumstances

A

validation

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5
Q

kills vegetative bacteria and some spores

A

bactericide

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6
Q

substances which stops growth but not kills

Usually start growing again after removed

A

bacteriostatic

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7
Q

bacterial cell capable of multiplication (as opposed to spore form which cannot multiply) less resistant than spore form

A

vegetative cell

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8
Q

body which some species of bacteria form within their cells which is more resistant than vegetative cell

A

spore

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9
Q

An agent that inhibits or destroys microorganisms on living tissue including skin, oral cavities, and open wounds.

A

aseptic

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10
Q

A chemical agent used on surfaces and objects to destroy infectious fungi, viruses, and bacteria, but not necessarily their spores.

A

chemical disinfectant

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11
Q

Sporicidal and antiviral agents may be considered a special class of _______

A

disinfectants.

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12
Q

Disinfectants are often categorized as __________________________ by medically oriented groups based upon their efficacy against various microorganisms.

A

high- level, intermediate-level, and low-level

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13
Q

An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.

A

cleaning agent

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14
Q

The removal of microorganisms by disinfection or sterilization.

A

decontamination

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15
Q

An agent for reducing, on surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria

A

sanitizing agent

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16
Q

An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.

A

sporicidal agent

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17
Q

: An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilants are liquid or vapor-phase agents

A

sterilant

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18
Q

common antiseptic for hand sanitizer

A

70%b isopropyl alcohol

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19
Q

how to select disinfectant in pharmaceutical manufacturing environments

A
  1. type and number of microorganisms to be controlled
  2. nature of surface material + compatibility with disinfectant
  3. corrosiveness of disinfectant with repeated use
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20
Q

2 tests to see efficacy of disinfectant

A

dilution test

surface challenge test

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21
Q

describe the surface dilution test

A

screening disinfectants for their efficacy at various concentrations and contact times against a wide range of standard test organisms and environmental isolates

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22
Q

describe the surface challenge test

A

using standard test microorganisms and microorganisms that are typical environmental isolates, applying disinfectants to surfaces at the selected use concentration with a specified contact time, and determining the log reduction of the challenge microorganisms

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23
Q

T or F: disinfectants have DIN numbers

A

T

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24
Q

Sterility Assurance Level (SAL) equal to probability of finding a non-sterile unit ____

A

< 10-6

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25
Q

describe steam under pressure

A

moist heat in the from of saturated steam under pressure (autoclaving)

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26
Q

what is the most reliable method for destruction of all organisms

A

autoclaving

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27
Q

how does steam under pressure kill cells

A

coagulation of cell proteins

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28
Q

typical autoclave conditions

A

121C for 15 min, 1bar = 15 psi

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29
Q

if P and T are not at required values in autoclave, what is wrong

A

air in chamber

30
Q

what is the D value

A

value in autoclaving for time to destroy 90% of bacterial cells or spore population

31
Q

5 applications of steam under pressure

A 
sealed solutions
bulk solutions
glassware
surgical dressing
instruments
32
Q

what can’t be sterilized by steam

A

oily preparations

moisture and heat sensitive preparations

33
Q

autoclaving monitoring technique

A

tape with white strips that change to black when temp conditions are met

34
Q

dry heat requires ___ temperatures and ____ exposure than sterilization by steam

A

higher

longer

35
Q

dry heat is applicable to

A

glassware
fixed oils
thermostable powders

36
Q

typical dry heat requirements

A

170C for >1hr

37
Q

filtration is good for (small or large) volumes and solutions that (can or can’t) be heated

A

small

can’t be heated

38
Q

how does filtration work

A

interlacing pores that trap bacteria or particles

39
Q

most common filter sizes

A

0.22 or 0.45 microns

40
Q

which sterilization method removes but doesn’t kill miroorganisms

A

filtration

41
Q

making sure a filter is compatible means that

A

making sure the drug does not adsorb to the filter

filter is inert

42
Q

the larger the volume of fluid, the _____ the SA of the filter should be

A

greater

43
Q

generally, particulate load for filtration is (high or low).

A

low

44
Q

for large volumes or high particulate contaminated solutions that are heat sensitive, what should you do

A

use a 5 micrometer prefilter as a clarifying filter

then use filtration normally

45
Q

direct filtration can use ______ and ______ pressure

A

positive and negaitve

46
Q

application of filtration

A

thermolabile solutions of low viscosity

47
Q

bubble point test tells us about

A

pore size and membrane integrity

48
Q

describe the bubble point test

A

once a membrane filter is wet, air can’t pass through it unless the bubble point pressure of the filter is exceeded

49
Q

filter for easy wetting and aqueous solutions

A

hydrophilic filters

50
Q

hydrophobic filters repels water but allows solvents like ____ and ____ to pass

A

alcohol and air

51
Q

how to make viscous oil filtration easier

A

heating it first reduces viscosity

52
Q

can powders be sterilized by filtration?

A

yes- dissolve powder in solvent, filter it, then evaporate solvent under aseptic conditions

53
Q

define gas disinfection

A

destruction of all living microorganisms with a chemical in a gaseous or vapor state

54
Q

how long does disinfection with gasses take

A

4-6 hours

55
Q

gas disinfecting conditions

A

30psi of pressure, temperature of 20-60C at 60% humidity for 4-6h

56
Q

8 applications for disinfecting gas

A 
thermoliable powder
plastics
polymers
ophthalmics
subctaneous
vaginal inserts
plastic syringes
tubing sets
57
Q

disadvantages of disinfecting gas

A

explosive
toxic
not good for solutions

58
Q

name a good bioilogical indicator

A

spores

59
Q

how to use spores as an indicator for liquid preps

A

add directly to preparation

60
Q

how to use spores as an indicator for solid preps or equipments

A

add to strips of filter paper

61
Q 
exotoxins = gram \_\_\_
endotoxins = gram \_\_\_\_
A 
exo = + and -
endo = -
62
Q

______ are the most prevalent pyrogen in aqueous solutions

A

endotoxins

63
Q

endotoxins are part of the _____ of bacteria

A

outer cell wall

64
Q

how to destroy endotoxins

A

heat at 250C for 4 hours

65
Q

biological activity of endotoxins are associated with

A

LPS lipid A

66
Q

3 types of endotoxins

A

A-B toxin
membrane disrupting
superantigens

67
Q

A-B toxin MOA

A

B binds to host cell receptor

A mediates enzyme activity responsible for toxicity

68
Q

how do membrane disrupting exotoxins work

A

disorganizing host cell membranes

69
Q

how to superantigen exotoxins work

A

stimulating T cells to release cytokines

70
Q

2 pyrgen tests

A

rabbit test

horseshoe crab test

71
Q

criteria for rabbit test to meet USP req for absence of pyrogens

A

no more than 3 of 8 rabbits show individual rises of 0.6C

sum of 8 temp rises <3.7

72
Q

how does the limulus amebocyte assay work

A

horseshoe crab blood rapidly forms a gel in presence of endotoxins

Y2S1 302 (10 decks)

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