Exam 1 review

Question 1

sources of contamination

Answer 1

-air
-breath
-skin
-hair
-clothes
-work surfaces

Question 2

Laminar Air Flow Hoods

Answer 2

-constant flow of air to prevent entry of contaminated air

Question 3

critical work surface area

Answer 3

space between HEPA filter and sterile product

Question 4

HEPA filter

Answer 4

High Efficiency Particulate Air filter removes
99.97% of all air particles 0.3mm or larger99.97% of all air particles 0.3mm or larger

Question 5

Barrier Isolator Technology

Answer 5

-closed system: used gloved ports
-personnel are primary source of contamination
-barrier remove personnel from equation
-good aseptic technique required

Question 6

parts of the needle to never touch?

Answer 6

tip and plunger

Question 7

Labeling

Answer 7

-name of product
- amount of drug and colume-manufacturer/distributor

Question 8

Top 10 excipients in injectable products

Answer 8

-water
-cosolvents
-oils
-sirfactants
-antimicrobial agent
-buffer
-antioxidant
-tonicity agent
-cryoprotectant
-competitive binding

Question 9

7 requirements of injectable products

Answer 9

-purity
-sterility
-sterile filtration
-particulates
-antimicrobial agent
-pyrogens
-isotonicity

Question 10

sources of microbial contamination

Answer 10

-raw material
-water
-air
-processing operations
-equipment
-employees
-environment

Question 11

approaches to sterility

Answer 11

-initial control
-terminal sterilization
-aseptic processing and sterile filtration for biologics
-antimicrobial agents

Question 12

major factors for microbial growth

Answer 12

-temp
-time of storage
-Co
-chemical
-gaseous environment: oxygen
-moisture content
-radiation

Question 13

death rates: first order kinetics

Answer 13

-D value: time in minutes to kill 90% of microbes

Question 14

biological indicator

Answer 14

specific microorganism resistant to a particular method of sterilization

Question 15

Validation of sterility

Answer 15

-add at known level and known D value and sterilize

Question 16

steam sterilization

Answer 16

-use steam to denature proteins
-metal needles, glass syringe, plastic bags, vial closures, single dose solution
-damages oils, proteins and powders

Question 17

dry heat sterilization

Answer 17

-in oven
-dehydration, denaturation, slow burning, or oxidation of proteins
-fats and oils: semi solids
-dry items in closed containers

Question 18

radiation sterilization

Answer 18

-gamma radiation
-when used on solutions, creates free radical which can damage DNA
-use on powders for injection and medical devices
-damages biologic drugs

Question 19

gas sterilization

Answer 19

-used EO gas and heat and moisture
-use on medical devices
-must allow gas to dissipate after sterilization

Question 20

sterile filtration

Answer 20

-physical removal of particles
-drug loss from filtration
-drug absorption
-protein adsorption at low conc.

Question 21

thromvoembolism

Answer 21

embolism of thrombus
-blood clot

Question 22

phlebitis

Answer 22

-inflammation of the vein
-pain and tenderness along course of vein
-reduce occurrence when IV infusions are filtered

Question 23

sources of particulates

Answer 23

-bacteria/fungi
-protein aggregation
-incompletely dissolved drug
-precipitates
-glass
-particles from rubber stoppers
-particles from plastic

Question 24

bacteriocidal

Answer 24

kills organisms

Question 25

bacteriostatic

Answer 25

prevents growth

Question 26

pH range where things can’t grow

Answer 26

below 3 and above 9

Question 27

hydroalcoholic preps

Answer 27

> 15% alcohol
-may not require antimicrobial agent

Question 28

hypertonic solutions

Answer 28

-67% sucrose in syrups
-micro-organisms can not grow

Question 29

antimicrobial agents

Answer 29

-Benzyl alcohol: not for neonates, intrathecal, or epidural
-can cause edema and anaphylaxis

Question 30

Pyrogens

Answer 30

-fever causing organic molecules
-caused by contamination
-primary source: water

Question 31

Limulus amebocyte lysate test

Answer 31

-horse shoe crab
-sample is incubated for one hour with blood lysate
-forms a gel in presence of pyrogen

Question 32

Rabbit febrile reaction

Answer 32

-sample injected into the ear vein of a rabbit
-rectal temp of animal is taken over 3 hours

Question 33

five rights

Answer 33

-med
-dose
-route
-patient
-time

Question 34

how to control absorption: fastest to slowest

Answer 34

-aqueuos solution
-suspension
oil solution
-oil in water
-water in oil
-oil suspension
pellet

Question 35

Noyes Whitney

Answer 35

dw = DSa(Cs - Ct)
dt h

Question 36

hydrolysis

Answer 36

-acid, base, water catalyzed hydrolysis of drugs
-B-lactams, esters, imines, and amides
-most prodrugs are esters

Question 37

oxidation

Answer 37

free radical rxs with oxygen
-causes rancidity of fats and natural oils

Question 38

first degree drying

Answer 38

-sublimation of ice by reduced pressure

Question 39

second degree drying

Answer 39

sublimation of water bound to solutes

Question 40

solid cake

Answer 40

same shape as frozen liquid but with honeycomb appearance

Question 41

Bulking agents

Answer 41

-increase physical and chemical stability of solid plug
-like mannitol