Compounding Flashcards

1
Q

If there are separate sterile and non-sterile C-PECs in the same C-SEC, how far must they be apart?

A

1 meter

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2
Q

What kind of pressure do C-PECs, C-SECs, and C-SCAs have to have?

A

negative pressure

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3
Q

In space where non-sterile HDs are compounded and in a C-SCA, how many air changes per hour (ACPH) should there be?

A

12

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4
Q

In a sterile C-SEC, how many ACPHs should there be?

A

30

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5
Q

Redundant HEPA filters can only be used in what type of compounding?

A

non-sterile HD compounding

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6
Q

How do HDs have to be stored?

A

stored separately from non-HDs in an externally ventilated, negative pressure room with at least 12 ACPH

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7
Q

What is the media-fill test used for?

A

sterile drug preparation

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8
Q

What is the gloved fingertip test used for?

A

hand hygiene, garbing, and gloving

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9
Q

How often do you have to pass a gloved fingertip test if compounding low and medium-risk CSPs?
What about high risk CSPs?

A

Annually
Semi-annually

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10
Q

How often does a media fill test need to be performed for low and medium risk CSPs?

A

annually

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11
Q

Tryptic soy broth (TSB) is used for what test?

A

media fill test

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12
Q

Tryptic soy agar (TSA) is used for what test?

A

gloved fingertip test and surface sampling

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13
Q

What temp should the fridge stay at?

A

2-8 C

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14
Q

What temp should the freezer be kept at?

A

between -25 and -10C

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15
Q

If a freezer contains vaccines, what temp should it be kept at?

A

between -50 to -15 C

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16
Q

How often should air sampling be done?

A

every 6 months

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17
Q

In surface sampling, action must be taken if CFUs are greater than what in ISO 5, ISO 7, and ISO 8 areas?

A

ISO 5: > 3 CFUs
ISO 7: > 5 CFUs
ISO 8: > 100 CFUs

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18
Q

How often should air pressure be checked?

A

Every work shift or once daily (minimally)

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19
Q

How often should humidity be checked?

A

daily

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20
Q

How long do you have to wait to start compounding in a PEC or C-PEC if the power was shut off?

A

30 minutes

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21
Q

What kind of wipes are used to clean a PEC?

A

lint-free sterile wipes

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22
Q

What is the order that PECs should be cleaned?

A

top to bottom, back to front
cleanest areas are cleaned first and dirtiest areas are cleaned last

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23
Q

ISO 5 PECs are cleaned how often (4)?

A

before each shift
every 30 minutes while working
before and after each batch of CSPs
whenever needed, including after spills

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24
Q

What items can be cleaned monthly in sterile compounding (6)?

A

ceiling, walls, shelves, chairs, bins, carts

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25
Q

What is the correct order of sanitization of HDs?

A
  1. Deactivation and decontamination
  2. Cleaning
  3. Disinfection
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26
Q

What’s used in deactivation and decontamination?

A

2% bleach (sodium hydrochlorite) or peroxide

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27
Q

reduces HD toxicity, then removes HD residues

A

deactivation and contamination

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28
Q

What’s used in cleaning?

A

germicidal detergent (quat, ammonium, phenolics)

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29
Q

removes dirt and microbial contamination

A

cleaning

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30
Q

What’s used in disinfection?

A

sterile 70% isopropyl alcohol

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31
Q

inhibits or destroys microorganism
required step in sterile compounding

A

disinfection

32
Q

To prevent corrosion from bleach on surfaces, what should you do after using bleach?

A

wipe surfaces with sodium thiosulfate, sterile alcohol, sterile water, or a germicidal detergent

33
Q

Name the items that go in black, yellow, and red bins.

A

Black = bulk HD waste
Yellow = trace HD waste
Red = non-hazardous sharps

34
Q

What bin do HD syringes go in?

A

yellow

35
Q

any containers (drug vials, IV bags) that contain a clearly visible amount of HD and any supplies that were used top administer HDs or to clean up HD spills

A

bulk HD waste (black bin)

36
Q

empty syringes, IV bags, used PPE (gowns, gloves, masks, and shoe covers)

A

trace HD waste (yellow bin)

37
Q

Pharmacists involved in hazardous compounding should perform wipe sampling of all compounding surfaces how often?

A

every 6 months

38
Q

When HDs are unpacked and they aren’t contained in plastic, what kind of mask should the staff member wear?

A

elastomeric half-mask, with a multi-gas cartridge and P100 filter

39
Q

What mask is sufficient for most HD compounding, but doesn’t provide adequate protection against gases, vapors, or direct liquid splashes?

A

N95 respirator

40
Q

When there is a risk of respiratory exposure, what 2 masks can be worn?

A

respirator mask with attached gas canisters

powered air-purifying respirator (PAPR)

41
Q

When administering any HD, what needs to be worn?

A

2 pairs of chemo gloves

42
Q

A single pair of chemo gloves can be used when?

A

HD receiving and storage

43
Q

How often should a gown be changed?

A

every 2-3 hours or immediately after a spill or splash

44
Q

How often do gloves need to be changed?

A

every 30 minutes

45
Q

For low-risk non-sterile HDs (intact tablets), how many pairs of gloves can be worn?

A

1

46
Q

What is the max recommended temp inside an SEC?

A

20 C (68 F)

47
Q

In what motion should the PEC be cleaned?

A

slightly overlapping, unidirectional strokes

48
Q

How often should counters and floors be cleaned in a sterile compounding area?

A

daily

49
Q

Metal spatulas should not be used with compounds containing what?

A

metal ions

50
Q

A graduate should not be used to measure volumes < __ of the graduate’s capacity.

A

20%

51
Q

What type of equipment is useful for measuring glycerin and mineral oil?

A

syringes (they are especially useful at measuring viscous liquids, which include glycerin and mineral oil)

52
Q

What part of a syringe should not be touched?

A

plunger

53
Q

Class A balance

A

Class III torsion balance

54
Q

Analytical balance

A

electronic balance

55
Q

Mortar used for liquids and for mixing compounds that are oily or can stain

A

glass mortar

56
Q

Mortar that has a rough surface and are preferred for grinding dry crystals and hard powders

A

wedgwood mortar

57
Q

Mortar that has a smooth surface and are preferred for blending powders and pulverizing gummy consistencies

A

porcelain mortar

58
Q

can be used as a work surface if the water content of the mixture won’t cause the paper to tear

A

disposable parchment ointment pads

59
Q

Electric mixing equipment that reduce the particle size, which increases the surface area and the rate of drug absorption

A

ointment mills, homogenizers, and grinders

60
Q

Electric mortar and pestle that can be used to mix ointments, creams, or other semi-solid particles

A

homogenizer

61
Q

Draws the ointment between rollers that grind and homogenize the ingredients

A

ointment mills

62
Q

Capsule shells can be made of what 2 things?

A

gelatin (pork-derived)
hypromellose (plant-derived)

63
Q

Largest capsule size for human use

A

000

64
Q

Smallest capsule size for human use

A

5

65
Q

If any substance comes from a non-FDA registered facility, what should be obtained and what does it confirm?

A

Certificate of Analysis

Confirms the specifications and quality of the substance

66
Q

If there is an ingredient without an expiration date, a pharmacist can assign a date that’s no more than how many years from the date of receipt?

A

3 years

67
Q

lowers the surface tension between 2 ingredients in a preparation to make them more miscible

A

surfactant

68
Q

Type of surfactant that reduces the surface tension between a liquid and a solid to permit the substance to more easily spread

A

wetting agent

69
Q

Type of surfactant that helps keep the liquid droplets dispersed throughout the liquid vehicle when added to a mixture with two or more liquids that are immiscible

A

emulsifier

70
Q

Type of surfactant that help keep solid particles from settling

A

suspending agent

71
Q

Type of surfactant added to aid in grinding particles down

A

levigating agent

72
Q

Levigating agent used for lipophilic compounds

A

mineral oil

73
Q

Levigating agents used for aqueous compounds

A

propylene glycol or glycerin

74
Q

Compounds that are commonly oxidized have what group attached to it?

A

hydroxyl (-OH) group

75
Q

BUD for non-aqueous formulations (e.g., drug in petrolatum)

A

6 months
store at room temp

76
Q

BUD for water-containing formulations (PO suspension)

A

14 days when stored at controlled cold temps
store in fridge

77
Q

BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations (cream or lotion)

A

30 days
store at room temp