Parenterals Part B Flashcards Preview

Pharmaceutics Spring 2016 > Parenterals Part B > Flashcards

Flashcards in Parenterals Part B Deck (63)
1

Total parenteral nutrition (TPN)

-used to provide nutrients to patients who can not take in nutrients orally

2

TPNs typically contain: (3)

-carb (dextrose)
-lipid (fat)
-amino acid (protein)

3

Base solutions are known as....

Macronutrients (amino acid solutions, dextrose, IV fat)

4

TNA or three in one admixture contain (3)

-IV emulsion
-amino acid
-dextrose

5

What is the problem with 3 in 1 admixtures?

emulsions are typically opaque (milky white) which makes it hard to see incompatibilities

6

If TPN is going to be going on for a while you may need both....

macronutrients and micronutrients

7

micronutrients are known as

electrolytes

8

What is the problem with using high concentrations of dextrose?

it is no longer isotonic, but hypertonic

9

T/F You only want to use manual compounding if it is required. Automated is better.

TRUE

10

TPN manual Gravity method for compounding?

special IV bag with transfer leads attached

11

TPN automated compounding? (2)

-saves time
-reduces potential error and contamination

12

Sterilization?

the complete destruction of all living organisms and their spores

13

Methods used for sterilization (5)

-steam sterilization
-dry heat sterilization
-sterilization by filtration
-gas sterilization
-ionizing radiation

14

SAL abbreviation?

Sterility assurance level

15

What is the SAL of terminal sterilization?filter sterilization?

terminal: 10^-6 (1 in a million)
filter: 10^-3 (1 in a thousand)

16

T/F Filter Sterilization is terminal sterilization

FALSE: IS NOT

17

Steam Sterilization is also known as .....

autoclaving (the best method)

18

T/F Autoclaving does not destroy pyrogens

TRUE; the material is pyrogen free due to distillation that uses WFSI

19

Steam Sterilization (2)

-moist heat causes denaturation of proteins
-saturated steam under pressure in autoclave 121 degrees celsius

20

Which of the following ampuls can be sterilized in an autoclave machine?
-drug in oil
-drug in WFSI

drug in WFSI because it makes its own pressure causing the pressure to be the same on the inside and outside of the ampul

21

T/F Dry Heat sterilization uses a higher temperature for a longer period of time than steam sterilization

TRUE

22

Dry Heat Sterilization (3)

-dehydration follow by oxidation
-removes pyrogens
-glassware can be covered w/aluminum foil and sterilized

23

Which of the following ampuls can be sterilized in by dry heat?
-drug in oil
-drug in WFSI

drug in oil

24

Filtration Sterilization (3)

-suitable for heat sensitive material (protein)
-does not remove pyrogens
-physical removal of microorganisms by 0.2 micron membrane filter

25

What tests checks the integrity of the filter (makes sure there is no breaks in the filter)?

Bubble point test
Pressure hold test

26

Gas sterilization (2)

-exposure to ethylene oxide gas diluted with an inert gas
-for heat and moisture sensitive material

27

In a gas chamber during sterilization what is controlled? (4)

-temperature
-humidity
-gas concentration
-exposure time

28

Ionizing Radiation Sterilization (2)

-gamma radiation from cobalt-60
-used for medical devices and hospital supplies

29

Sterilization needs to be validated, how is this possible? (4)

-biological indicators
-recording thermocouples
-color change indicators
-melting indicators

30

What does the USP 797 classify CSP as low risk? (2)

-made outside the PEC and is intended for emergency use
-administration must be given no later than 1 hour

31

T/F Low risk CSPs are prepared from sterile commercial ingredients using sterile commercial devices, maintained in an ISO Class 5 environment

TRUE

32

What does the USP 797 classify CSP as medium risk?

making a TPN (going in a lot of times)

33

What does the USP 797 classify CSP as high risk?

Compounding sterile preparations from non-sterile ingredients is always categorized as high risk compounding

34

The facility design that is desired for CSP?

has ISO class 5 PEC, and ISO class 7 and class 8 (has pressure differientation)

35

Sterility Test (2)

-primarily used as a check test
-direct inoculation and membrane filtration method

36

When is a product deemed to pass sterility test?

if all media vessels incubated with product sample reveal no evidence of microbial growth (turbidity)

37

T/F Pyrogens are endotoxins

TRUE

38

Endotoxins (5)

-gram negative
-potent
-very stable
-will pass through 0.2 um filters
-not destroyed by autoclaving

39

What tests can be used for pyrogen testing?

rabbit test or LAL test kit

40

Air sampling methods? (3)

-settling plates
-electronic air particles counters
-centrifugal air sample

41

Settling plate method

will see colonies of bacteria if infected

42

Electronic air particle counter

count viable and nonviable

43

Surface sampling methods? (2)

-rodac plates (convex surface)
-swab-rinse test

44

T/F Most common drug products are COMPATIBLE when added to common LVP vehicles

FALSE: An estimated 30% of common drug products are incompatible or unstable when added to common LVP vehicles

45

-change in color or appearance
-change in acid-base environment
-pH of things being mixed
-solubility problems
Are what type of incompatibilities?

physical

46

-hydrolysis
-oxidation (may result in color change)
-photolysis (light), complexation
-compatibility of preservative
Are what type of incompatibility?

chemical

47

To avoid precipitation what can be done?

changing the order of mixing

48

For CSP, media fills should be performed...

at least annually for each person authorized to compound
-semiannually for high risk

49

T/F Personnel glove fingertip sampling is REQUIRED

TRUE

50

Automated Compounding Devices are used to make

TPNs

51

For cytotoxic drugs you should use _____ flow, to protect the product, person, and the environment

vertical; via the biological safety cabinet

52

T/F You SHOULD put air in the vial for chemo drugs.

FALSE; You DO NOT put air in the vial for chemo drugs because it may squirt out

53

Chemo dispensing pins are used.....

for cytotoxic drugs to keep pressure in equilibrium

54

What are 3 PECs?

-biological flow hood
-laminar flow hood
-barrier isolator

55

Needle free injections are useful for?

mass vaccination

56

microsphere formation

drug is dispersed in a polymer matrix (this is used for proteins since they have a short half life)

57

CLASS ACTIVITY: Microspheres are typically around 100um, how can they be administered parenterally?

-can give SubQ or IM (just needs to be sterile)

58

___ is the primary extracellular cation

-important to maintain normal extracellular fluids

Sodium

59

___ is the primary intracellular cation

-balance is important to avoid hypo and hyper kalemia

Potassium

60

Potassium preparations must be....

diluted and given by slow IV infusion otherwise it could cause cardiac arrest

61

T/F Bicarbonate balance includes consideration of acid-base balance and acidosis/alkalosis. Chloride ion is also important to maintain the acid-base balance

TRUE

62

Irrigation and dialysis solutions are...

employed outside the circulatory system but still need to be sterile

63

_______ solutions are used to bathe or wash wounds, surgical incisions, or body tissues

irrigation