Sterile and Non-Sterile Compounding Flashcards

(125 cards)

1
Q

What is aseptic technique?

A

Methods to prevent contamination during sterile preparation

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2
Q

What is the purpose of a laminar flow hood?

A

Provide sterile environment for IV preparation

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3
Q

What direction does air flow in a horizontal laminar flow hood?

A

From back to front toward the operator

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4
Q

What direction does air flow in a vertical laminar flow hood?

A

From top to bottom

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5
Q

What is a biological safety cabinet?

A

Enclosed workspace for handling hazardous materials

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6
Q

What is the difference between Class I and Class II biological safety cabinets?

A

Class I protects operator

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7
Q

How should hands be washed before sterile compounding?

A

Antimicrobial soap for at least 30 seconds

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8
Q

What is the proper order for donning sterile garb?

A

Shoe covers hair cover face mask hand hygiene gown gloves

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9
Q

How often should the laminar flow hood be cleaned?

A

At beginning of each shift and every 30 minutes during use

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10
Q

What disinfectant is used for hood cleaning?

A

70% isopropyl alcohol

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11
Q

How should the hood be cleaned?

A

Back to front top to bottom overlapping strokes

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12
Q

How long should the hood run before use?

A

At least 30 minutes

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13
Q

What is the critical area in a laminar flow hood?

A

6 inches from back and sides where sterile work is performed

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14
Q

What should never be placed in the critical area?

A

Hands non-sterile items anything that blocks airflow

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15
Q

What is a HEPA filter?

A

High Efficiency Particulate Air filter (removes 99.97% of particles)

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16
Q

What is the first zone in sterile compounding?

A

Anteroom for preparation and garbing

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17
Q

What is the second zone in sterile compounding?

A

Buffer room containing laminar flow hood

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18
Q

What pressure differential is required between zones?

A

Positive pressure gradient from cleanest to least clean area

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19
Q

What is media fill testing?

A

Growing microorganisms in prepared solutions to test sterility

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20
Q

How often should media fill testing be performed?

A

Initially annually and after significant changes to process

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21
Q

What is the beyond use date for low-risk sterile preparations?

A

48 hours at room temperature 14 days refrigerated

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22
Q

What is the beyond use date for medium-risk sterile preparations?

A

30 hours at room temperature 9 days refrigerated

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23
Q

What is the beyond use date for high-risk sterile preparations?

A

24 hours at room temperature 3 days refrigerated

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24
Q

What defines low-risk sterile compounding?

A

Simple transfers with sterile ingredients and devices

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25
What defines medium-risk sterile compounding?
Multiple sterile ingredients or complex manipulations
26
What defines high-risk sterile compounding?
Non-sterile ingredients or exposed to air quality worse than ISO 5
27
What is an ISO 5 environment?
Cleanroom classification allowing maximum 3520 particles ≥0.5 microns per cubic meter
28
What is an ampule?
Sealed glass container that must be broken to access contents
29
What is a vial?
Container with rubber stopper accessed by needle
30
What size needle is used for withdrawing from vials?
18-20 gauge
31
What size needle is used for injections?
25-27 gauge (smaller for patient comfort)
32
What is a filter needle?
Needle with internal filter to remove particles
33
When should filter needles be used?
When withdrawing from ampules to remove glass particles
34
What is positive pressure in a vial?
More air pressure inside than outside
35
What is negative pressure in a vial?
Less air pressure inside than outside
36
How do you create positive pressure?
Inject more air than volume to be withdrawn
37
What is the milking technique?
Method to withdraw solution from vial using pressure differentials
38
What is an IV bag?
Flexible plastic container for IV solutions
39
What are the injection ports on an IV bag?
Medication port (for adding drugs) and administration port (for tubing)
40
What is a mini-bag?
Small volume IV bag (50-250 mL) for piggyback administration
41
What is a large volume parenteral (LVP)?
IV solution greater than 100 mL
42
What is a small volume parenteral (SVP)?
IV solution 100 mL or less
43
What is TPN?
Total Parenteral Nutrition - complete nutrition via IV
44
What components are in TPN?
Amino acids dextrose lipids electrolytes vitamins trace elements
45
What is a 3-in-1 TPN?
TPN with lipids mixed in the same bag
46
Why are lipids sometimes hung separately?
Incompatibility issues or stability concerns
47
What is the maximum osmolarity for peripheral IV?
900 mOsm/L
48
What osmolarity requires central line access?
Greater than 900 mOsm/L
49
What is chemotherapy?
Cytotoxic drugs used to treat cancer
50
What special precautions are needed for chemotherapy?
Biological safety cabinet protective equipment special disposal
51
What is a closed system drug transfer device (CSTD)?
Device to prevent escape of hazardous drugs during preparation
52
What is the purpose of priming IV tubing?
Remove air bubbles and fill tubing with solution
53
What is an air bubble test?
Check for leaks in IV preparation
54
What causes precipitates in IV solutions?
Drug incompatibilities pH changes concentration changes
55
What is physical incompatibility?
Visible precipitation color change or gas formation
56
What is chemical incompatibility?
Drug degradation without visible changes
57
What is the most common IV solution?
Normal saline (0.9% sodium chloride)
58
What is D5W?
5% dextrose in water
59
What is lactated Ringer's solution?
Balanced electrolyte solution
60
What is half normal saline?
0.45% sodium chloride
61
What is the tonicity of normal saline?
Isotonic
62
What happens with hypotonic solutions?
Water moves into cells causing them to swell
63
What happens with hypertonic solutions?
Water moves out of cells causing them to shrink
64
What is buffering capacity?
Ability to resist pH changes
65
What causes color changes in IV solutions?
Drug degradation oxidation or light exposure
66
How should light-sensitive drugs be protected?
Amber containers or foil wrapping
67
What drugs are light-sensitive?
Furosemide nitroprusside amphotericin B
68
What is refrigerated storage temperature?
36-46°F (2-8°C)
69
What is room temperature storage?
68-77°F (20-25°C)
70
What is controlled room temperature?
68-77°F with excursions allowed to 59-86°F
71
What is non-sterile compounding?
Preparation of medications without sterile technique
72
What equipment is used for non-sterile compounding?
Balances mortars and pestles graduated cylinders beakers
73
What is the difference between Class A and Class III balances?
Class A (analytical) is more precise than Class III (prescription)
74
What is the minimum weighable quantity?
Smallest amount that can be accurately weighed (usually 120 mg)
75
What is geometric dilution?
Mixing technique starting with smallest amount and doubling
76
What is trituration?
Grinding and mixing in a mortar and pestle
77
What is levigation?
Mixing with a small amount of liquid to form paste
78
What is a mortar and pestle made of?
Glass porcelain or Wedgwood
79
Which mortar is best for liquids?
Glass mortar
80
Which mortar is best for grinding?
Porcelain mortar
81
What is an ointment base?
Vehicle for topical medications
82
What are the types of ointment bases?
Hydrocarbon absorption water-removable water-soluble
83
What is petrolatum?
Hydrocarbon ointment base
84
What is a cream?
Semi-solid emulsion (oil-in-water or water-in-oil)
85
What is a gel?
Semi-solid system with liquid dispersed in solid
86
What is a paste?
Semi-solid preparation with high powder concentration
87
What is an emulsion?
Mixture of two immiscible liquids
88
What is an emulsifying agent?
Substance that helps form and stabilize emulsions
89
What is HLB value?
Hydrophile-Lipophile Balance (measures emulsifier properties)
90
What is a suspension?
Liquid containing undissolved particles
91
What is a solution?
Homogeneous mixture where solute is completely dissolved
92
What is solubility?
Maximum amount of solute that dissolves in solvent
93
What factors affect solubility?
Temperature pH particle size stirring
94
What is saturation?
Solution containing maximum dissolved solute at given temperature
95
What is supersaturation?
Solution containing more solute than normally possible
96
What is precipitation?
Formation of solid particles from solution
97
What is crystallization?
Formation of crystals from solution
98
What is polymorphism?
Different crystal forms of same compound
99
What affects bioavailability in compounded preparations?
Particle size crystal form excipients
100
What is particle size reduction?
Breaking larger particles into smaller ones
101
What methods reduce particle size?
Comminution micronization trituration
102
What is comminution?
Process of particle size reduction
103
What is micronization?
Reducing particles to micron size
104
What is the purpose of particle size reduction?
Improve dissolution bioavailability and mixing
105
What is capsule filling?
Process of putting powder or liquid into capsule shells
106
What are hard gelatin capsules?
Two-piece capsules for powder or granule filling
107
What are soft gelatin capsules?
One-piece capsules for liquid filling
108
What is the punch method?
Capsule filling technique using capsule as scoop
109
What is capsule sizes range?
000 (largest) to 5 (smallest)
110
What is the most common capsule size?
Size 0
111
What is tablet crushing?
Breaking tablets into smaller pieces or powder
112
When should tablets not be crushed?
Extended-release enteric-coated sublingual or hazardous drugs
113
What equipment is used for tablet crushing?
Mortar and pestle or commercial tablet crusher
114
What is reconstitution?
Adding liquid to powder to form solution or suspension
115
What is the most common reconstituting vehicle?
Purified water
116
What factors affect stability of reconstituted products?
Temperature pH light concentration
117
What is the beyond use date for water-containing preparations?
14 days when stored in refrigerator
118
What is the beyond use date for non-aqueous preparations?
25% of remaining time to expiration or 6 months (whichever is less)
119
What is required on compounded preparation labels?
Beyond use date lot number preparation date storage requirements
120
What is a lot number?
Unique identifier for batch of compounded preparations
121
What information should be in compounding records?
Formula sources quantities procedures beyond use date
122
How long should compounding records be kept?
At least 3 years
123
What is quality control in compounding?
Testing to ensure preparations meet specifications
124
What tests are performed on compounded preparations?
Appearance pH weight variation content uniformity
125
What is potency testing?
Measuring active ingredient concentration