2: Sterilization

Question 1

define sterility

Answer 1

absence of viable microorganisms

Question 2

define aseptic processing

Answer 2

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

Question 3

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

Answer 3

bioburden

Question 4

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

Answer 4

validation

Question 5

kills vegetative bacteria and some spores

Answer 5

bactericide

Question 6

substances which stops growth but not kills

Usually start growing again after removed

Answer 6

bacteriostatic

Question 7

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

Answer 7

vegetative cell

Question 8

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

Answer 8

spore

Question 9

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

Answer 9

aseptic

Question 10

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

Answer 10

chemical disinfectant

Question 11

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

Answer 11

disinfectants.

Question 12

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

Answer 12

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

Question 13

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

Answer 13

cleaning agent

Question 14

The removal of microorganisms by disinfection or sterilization.

Answer 14

decontamination

Question 15

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

Answer 15

sanitizing agent

Question 16

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.

Answer 16

sporicidal agent

Question 17

: 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

Answer 17

sterilant

Question 18

common antiseptic for hand sanitizer

Answer 18

70%b isopropyl alcohol

Question 19

how to select disinfectant in pharmaceutical manufacturing environments

Answer 19

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

Question 20

2 tests to see efficacy of disinfectant

Answer 20

dilution test

surface challenge test

Question 21

describe the surface dilution test

Answer 21

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

Question 22

describe the surface challenge test

Answer 22

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

Question 23

T or F: disinfectants have DIN numbers

Answer 23

T

Question 24

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

Answer 24

< 10-6

Question 25

describe steam under pressure

Answer 25

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

Question 26

what is the most reliable method for destruction of all organisms

Answer 26

autoclaving

Question 27

how does steam under pressure kill cells

Answer 27

coagulation of cell proteins

Question 28

typical autoclave conditions

Answer 28

121C for 15 min, 1bar = 15 psi

Question 29

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

Answer 29

air in chamber

Question 30

what is the D value

Answer 30

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

Question 31

5 applications of steam under pressure

Answer 31

``` sealed solutions bulk solutions glassware surgical dressing instruments ```

Question 32

what can't be sterilized by steam

Answer 32

oily preparations | moisture and heat sensitive preparations

Question 33

autoclaving monitoring technique

Answer 33

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

Question 34

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

Answer 34

higher | longer

Question 35

dry heat is applicable to

Answer 35

glassware fixed oils thermostable powders

Question 36

typical dry heat requirements

Answer 36

170C for >1hr

Question 37

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

Answer 37

small | can't be heated

Question 38

how does filtration work

Answer 38

interlacing pores that trap bacteria or particles

Question 39

most common filter sizes

Answer 39

0.22 or 0.45 microns

Question 40

which sterilization method removes but doesn't kill miroorganisms

Answer 40

filtration

Question 41

making sure a filter is compatible means that

Answer 41

making sure the drug does not adsorb to the filter | filter is inert

Question 42

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

Answer 42

greater

Question 43

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

Answer 43

low

Question 44

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

Answer 44

use a 5 micrometer prefilter as a clarifying filter | then use filtration normally

Question 45

direct filtration can use ______ and ______ pressure

Answer 45

positive and negaitve

Question 46

application of filtration

Answer 46

thermolabile solutions of low viscosity

Question 47

bubble point test tells us about

Answer 47

pore size and membrane integrity

Question 48

describe the bubble point test

Answer 48

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

Question 49

filter for easy wetting and aqueous solutions

Answer 49

hydrophilic filters

Question 50

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

Answer 50

alcohol and air

Question 51

how to make viscous oil filtration easier

Answer 51

heating it first reduces viscosity

Question 52

can powders be sterilized by filtration?

Answer 52

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

Question 53

define gas disinfection

Answer 53

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

Question 54

how long does disinfection with gasses take

Answer 54

4-6 hours

Question 55

gas disinfecting conditions

Answer 55

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

Question 56

8 applications for disinfecting gas

Answer 56

``` thermoliable powder plastics polymers ophthalmics subctaneous vaginal inserts plastic syringes tubing sets ```

Question 57

disadvantages of disinfecting gas

Answer 57

explosive toxic not good for solutions

Question 58

name a good bioilogical indicator

Answer 58

spores

Question 59

how to use spores as an indicator for liquid preps

Answer 59

add directly to preparation

Question 60

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

Answer 60

add to strips of filter paper

Question 61

``` exotoxins = gram ___ endotoxins = gram ____ ```

Answer 61

``` exo = + and - endo = - ```

Question 62

______ are the most prevalent pyrogen in aqueous solutions

Answer 62

endotoxins

Question 63

endotoxins are part of the _____ of bacteria

Answer 63

outer cell wall

Question 64

how to destroy endotoxins

Answer 64

heat at 250C for 4 hours

Question 65

biological activity of endotoxins are associated with

Answer 65

LPS lipid A

Question 66

3 types of endotoxins

Answer 66

A-B toxin membrane disrupting superantigens

Question 67

A-B toxin MOA

Answer 67

B binds to host cell receptor | A mediates enzyme activity responsible for toxicity

Question 68

how do membrane disrupting exotoxins work

Answer 68

disorganizing host cell membranes

Question 69

how to superantigen exotoxins work

Answer 69

stimulating T cells to release cytokines

Question 70

2 pyrgen tests

Answer 70

rabbit test | horseshoe crab test

Question 71

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

Answer 71

no more than 3 of 8 rabbits show individual rises of 0.6C | sum of 8 temp rises <3.7

Question 72

how does the limulus amebocyte assay work

Answer 72

horseshoe crab blood rapidly forms a gel in presence of endotoxins