Flashcards in Parenterals Part B Deck (63)
Total parenteral nutrition (TPN)
-used to provide nutrients to patients who can not take in nutrients orally
TPNs typically contain: (3)
-amino acid (protein)
Base solutions are known as....
Macronutrients (amino acid solutions, dextrose, IV fat)
TNA or three in one admixture contain (3)
What is the problem with 3 in 1 admixtures?
emulsions are typically opaque (milky white) which makes it hard to see incompatibilities
If TPN is going to be going on for a while you may need both....
macronutrients and micronutrients
micronutrients are known as
What is the problem with using high concentrations of dextrose?
it is no longer isotonic, but hypertonic
T/F You only want to use manual compounding if it is required. Automated is better.
TPN manual Gravity method for compounding?
special IV bag with transfer leads attached
TPN automated compounding? (2)
-reduces potential error and contamination
the complete destruction of all living organisms and their spores
Methods used for sterilization (5)
-dry heat sterilization
-sterilization by filtration
Sterility assurance level
What is the SAL of terminal sterilization?filter sterilization?
terminal: 10^-6 (1 in a million)
filter: 10^-3 (1 in a thousand)
T/F Filter Sterilization is terminal sterilization
FALSE: IS NOT
Steam Sterilization is also known as .....
autoclaving (the best method)
T/F Autoclaving does not destroy pyrogens
TRUE; the material is pyrogen free due to distillation that uses WFSI
Steam Sterilization (2)
-moist heat causes denaturation of proteins
-saturated steam under pressure in autoclave 121 degrees celsius
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
T/F Dry Heat sterilization uses a higher temperature for a longer period of time than steam sterilization
Dry Heat Sterilization (3)
-dehydration follow by oxidation
-glassware can be covered w/aluminum foil and sterilized
Which of the following ampuls can be sterilized in by dry heat?
-drug in oil
-drug in WFSI
drug in oil
Filtration Sterilization (3)
-suitable for heat sensitive material (protein)
-does not remove pyrogens
-physical removal of microorganisms by 0.2 micron membrane filter
What tests checks the integrity of the filter (makes sure there is no breaks in the filter)?
Bubble point test
Pressure hold test
Gas sterilization (2)
-exposure to ethylene oxide gas diluted with an inert gas
-for heat and moisture sensitive material
In a gas chamber during sterilization what is controlled? (4)
Ionizing Radiation Sterilization (2)
-gamma radiation from cobalt-60
-used for medical devices and hospital supplies
Sterilization needs to be validated, how is this possible? (4)
-color change indicators
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
T/F Low risk CSPs are prepared from sterile commercial ingredients using sterile commercial devices, maintained in an ISO Class 5 environment
What does the USP 797 classify CSP as medium risk?
making a TPN (going in a lot of times)
What does the USP 797 classify CSP as high risk?
Compounding sterile preparations from non-sterile ingredients is always categorized as high risk compounding
The facility design that is desired for CSP?
has ISO class 5 PEC, and ISO class 7 and class 8 (has pressure differientation)
Sterility Test (2)
-primarily used as a check test
-direct inoculation and membrane filtration method
When is a product deemed to pass sterility test?
if all media vessels incubated with product sample reveal no evidence of microbial growth (turbidity)
T/F Pyrogens are endotoxins
-will pass through 0.2 um filters
-not destroyed by autoclaving
What tests can be used for pyrogen testing?
rabbit test or LAL test kit
Air sampling methods? (3)
-electronic air particles counters
-centrifugal air sample
Settling plate method
will see colonies of bacteria if infected
Electronic air particle counter
count viable and nonviable
Surface sampling methods? (2)
-rodac plates (convex surface)
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
-change in color or appearance
-change in acid-base environment
-pH of things being mixed
Are what type of incompatibilities?
-oxidation (may result in color change)
-photolysis (light), complexation
-compatibility of preservative
Are what type of incompatibility?
To avoid precipitation what can be done?
changing the order of mixing
For CSP, media fills should be performed...
at least annually for each person authorized to compound
-semiannually for high risk
T/F Personnel glove fingertip sampling is REQUIRED
Automated Compounding Devices are used to make
For cytotoxic drugs you should use _____ flow, to protect the product, person, and the environment
vertical; via the biological safety cabinet
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
Chemo dispensing pins are used.....
for cytotoxic drugs to keep pressure in equilibrium
What are 3 PECs?
-biological flow hood
-laminar flow hood
Needle free injections are useful for?
drug is dispersed in a polymer matrix (this is used for proteins since they have a short half life)
CLASS ACTIVITY: Microspheres are typically around 100um, how can they be administered parenterally?
-can give SubQ or IM (just needs to be sterile)
___ is the primary extracellular cation
-important to maintain normal extracellular fluids
___ is the primary intracellular cation
-balance is important to avoid hypo and hyper kalemia
Potassium preparations must be....
diluted and given by slow IV infusion otherwise it could cause cardiac arrest
T/F Bicarbonate balance includes consideration of acid-base balance and acidosis/alkalosis. Chloride ion is also important to maintain the acid-base balance
Irrigation and dialysis solutions are...
employed outside the circulatory system but still need to be sterile