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Pharmaceutics Spring 2016 > Parenterals Part B > Flashcards

Parenterals Part B Flashcards

1
Q

Total parenteral nutrition (TPN)

A

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

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2
Q

TPNs typically contain: (3)

A
  • carb (dextrose)
  • lipid (fat)
  • amino acid (protein)
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3
Q

Base solutions are known as….

A

Macronutrients (amino acid solutions, dextrose, IV fat)

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4
Q

TNA or three in one admixture contain (3)

A
  • IV emulsion
  • amino acid
  • dextrose
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5
Q

What is the problem with 3 in 1 admixtures?

A

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

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6
Q

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

A

macronutrients and micronutrients

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7
Q

micronutrients are known as

A

electrolytes

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8
Q

What is the problem with using high concentrations of dextrose?

A

it is no longer isotonic, but hypertonic

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9
Q

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

A

TRUE

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10
Q

TPN manual Gravity method for compounding?

A

special IV bag with transfer leads attached

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11
Q

TPN automated compounding? (2)

A
  • saves time

- reduces potential error and contamination

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12
Q

Sterilization?

A

the complete destruction of all living organisms and their spores

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13
Q

Methods used for sterilization (5)

A
  • steam sterilization
  • dry heat sterilization
  • sterilization by filtration
  • gas sterilization
  • ionizing radiation
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14
Q

SAL abbreviation?

A

Sterility assurance level

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15
Q

What is the SAL of terminal sterilization?filter sterilization?

A

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

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16
Q

T/F Filter Sterilization is terminal sterilization

A

FALSE: IS NOT

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17
Q

Steam Sterilization is also known as …..

A

autoclaving (the best method)

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18
Q

T/F Autoclaving does not destroy pyrogens

A

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

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19
Q

Steam Sterilization (2)

A
  • moist heat causes denaturation of proteins

- saturated steam under pressure in autoclave 121 degrees celsius

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20
Q

Which of the following ampuls can be sterilized in an autoclave machine?

  • drug in oil
  • drug in WFSI
A

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

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21
Q

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

A

TRUE

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22
Q

Dry Heat Sterilization (3)

A
  • dehydration follow by oxidation
  • removes pyrogens
  • glassware can be covered w/aluminum foil and sterilized
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23
Q

Which of the following ampuls can be sterilized in by dry heat?

  • drug in oil
  • drug in WFSI
A

drug in oil

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24
Q

Filtration Sterilization (3)

A
  • suitable for heat sensitive material (protein)
  • does not remove pyrogens
  • physical removal of microorganisms by 0.2 micron membrane filter
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25
Q

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

A

Bubble point test

Pressure hold test

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26
Q

Gas sterilization (2)

A
  • exposure to ethylene oxide gas diluted with an inert gas

- for heat and moisture sensitive material

27
Q

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

A
  • temperature
  • humidity
  • gas concentration
  • exposure time
28
Q

Ionizing Radiation Sterilization (2)

A
  • gamma radiation from cobalt-60

- used for medical devices and hospital supplies

29
Q

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

A
  • biological indicators
  • recording thermocouples
  • color change indicators
  • melting indicators
30
Q

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

A
  • made outside the PEC and is intended for emergency use

- administration must be given no later than 1 hour

31
Q

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

A

TRUE

32
Q

What does the USP 797 classify CSP as medium risk?

A

making a TPN (going in a lot of times)

33
Q

What does the USP 797 classify CSP as high risk?

A

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

34
Q

The facility design that is desired for CSP?

A

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

35
Q

Sterility Test (2)

A
  • primarily used as a check test

- direct inoculation and membrane filtration method

36
Q

When is a product deemed to pass sterility test?

A

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

37
Q

T/F Pyrogens are endotoxins

A

TRUE

38
Q

Endotoxins (5)

A
  • gram negative
  • potent
  • very stable
  • will pass through 0.2 um filters
  • not destroyed by autoclaving
39
Q

What tests can be used for pyrogen testing?

A

rabbit test or LAL test kit

40
Q

Air sampling methods? (3)

A
  • settling plates
  • electronic air particles counters
  • centrifugal air sample
41
Q

Settling plate method

A

will see colonies of bacteria if infected

42
Q

Electronic air particle counter

A

count viable and nonviable

43
Q

Surface sampling methods? (2)

A
  • rodac plates (convex surface)

- swab-rinse test

44
Q

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

A

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

45
Q

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

A

physical

46
Q

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

A

chemical

47
Q

To avoid precipitation what can be done?

A

changing the order of mixing

48
Q

For CSP, media fills should be performed…

A

at least annually for each person authorized to compound

-semiannually for high risk

49
Q

T/F Personnel glove fingertip sampling is REQUIRED

A

TRUE

50
Q

Automated Compounding Devices are used to make

A

TPNs

51
Q

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

A

vertical; via the biological safety cabinet

52
Q

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

A

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

53
Q

Chemo dispensing pins are used…..

A

for cytotoxic drugs to keep pressure in equilibrium

54
Q

What are 3 PECs?

A
  • biological flow hood
  • laminar flow hood
  • barrier isolator
55
Q

Needle free injections are useful for?

A

mass vaccination

56
Q

microsphere formation

A

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

57
Q

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

A

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

58
Q

___ is the primary extracellular cation

-important to maintain normal extracellular fluids

A

Sodium

59
Q

___ is the primary intracellular cation

-balance is important to avoid hypo and hyper kalemia

A

Potassium

60
Q

Potassium preparations must be….

A

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

61
Q

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

A

TRUE

62
Q

Irrigation and dialysis solutions are…

A

employed outside the circulatory system but still need to be sterile

63
Q

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

A

irrigation

Pharmaceutics Spring 2016 (20 decks)

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