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NAPLEX 21 > Compounding I: Basics > Flashcards

Compounding I: Basics Flashcards

1
Q

A series of safety documents required by the occupational safety and health administration to be accessible to all employees who are working with hazodous material

A

SDS “safety data sheets”

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2
Q

Where are powders made?

A

in a powder containment hood

“Ventilated compounding enclosure”

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3
Q

The sterile compounding space must include an”

A

anteroom

buffer area

primary engineering control or a segregated compounding area

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4
Q

Hoods and buffer rooms used for compounding HDs begin with the word

A

containment “C-PEC, C-SEC”

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5
Q

The C-sec must contain what type of ISO

A

ISO 7

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6
Q

There must be separate sterile and non-sterile C-PECs kept how far apart

A

1 meter

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7
Q

C-PECs and C-SECs must have what type of air pressure

A

negative

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8
Q

HD drugs must be stored separately from non-HD drugs in an externally ventilated ____ pressure room with at least ___ ACPH

A

negative, 12

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9
Q

Sterile HD ACPH=

A

30 ACPH

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10
Q

non-sterile HD ACPH=

A

12 ACPH

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11
Q

What is used when external venting is not reasonable

A

Redundant HEPA filters

*can only be used for non-sterile HD

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12
Q

The sterile hood, there are different types including conventional laminar airflow workbench and a compounding aseptic isolater

A

primary engineering control (PEC)

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13
Q

The buffer room or sterile compounding room

A

SEC

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14
Q

The isolator

A

compounding aseptic isolator

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15
Q

This is the chemo hood for sterile chemo drugs and other sterile HDs. this is a containment PEC or C-PEC

A

Class II biological safety cabinet (BSC)

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16
Q

The isolator glove box for HDs

A

compounding aseptic containment isolator

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17
Q

The room where the C-PEC Is located is called

A

the containment secondary engineering control or C-SEC

If the hood is not in a C-SEC, then it has to be in a compounding aseptic containment isolator

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18
Q

IV container up to 100mL

A

small parenteral

> 100mL is large

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19
Q

In critical areas that are closest to exposed sterile drugs and containers (inside the sterile hood, PEC) the air must be at least ISO__

A

5

0.5m

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20
Q

ISO rating: PEC

A

5

3520 particles

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21
Q

ISO rating: SEC/buffer room

A

ISO 7

352000

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22
Q

ISO rating for anteroom if it opens into a negative pressure SEC

A

7

same ISO # as the SEC

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23
Q

Ante room if it opens into a positive pressure SEC

A

8

24
Q

Biological Safety Cabinet (BSC) =

A

the C-PEC

25
Q

Laminar airflow workbench =

A

PEC

26
Q

What is first air?

A

air from the HEPA filter

checked every 6 months

27
Q

What is the line that separates a room clean and dirty sections

A

line of demarcation

28
Q

hazardous and non hazardous drugs must be down in what type of air pressure room

A

negative

for others it doesn’t matter

29
Q

What is the compounding aseptic isolators?

A

this is what we used when our clean room was messed up and still have to make the TPNs and it was located in a segregated compounding area (SCA)

for HD = “CACI”

30
Q

The maximum BUD for CSPs made in an isolator in an SCA or C-SCA is

A

12 hours

31
Q

in a positive pressure area the ISO must be

A

8

32
Q

in a negative pressure area the ISO must be

A

7

33
Q

What is the color of the waste bucket for non hazardous

A

red

sharps and non HD waste

34
Q

color of the waste bucket for hazardous

A

yellow

trace HD waste - vials and syringes

35
Q

for the finger print test, what is the finger print test use to plate it

A

tryptic soy agar (TSA)

CFU = contaminated
passing = 3 consecutive passes
36
Q

what does the media fill use to see if there is bacteria

A

tryptic soy broth

pass = clean for 14 days

37
Q

how often should the temp be monitored

A

once daily in the SEC

should be 68 or cooler

38
Q

fridge (2-8C) and freezer (-50–15) monitored how often

A

daily

vaccines = twice daily

39
Q

air sampling should be performed

A

every 6 months

40
Q

surface sampling that’s tested with TSA(+polysorbate 80 and lecithin) are added to the TSA to neutralize the effect of any disinfecting agents on the surfaces

A

periodically

> 3CFU in the ISO 5 area
5CFU in the iso 7 area
100 CFU in the iso 8 area
= TAKE ACTION

41
Q

air pressure testing every

A

once daily or every work shift

42
Q

What is cleaned every day?

A

counters
floors
carts

43
Q

cleaned weekly?

A 
walls
windows
shelving
bins
chairs
44
Q

Monthly cleaning?

A

ceiling

45
Q

What are the steps to cleaning

A

deactivation and decontamination

cleaning

disinfection

46
Q

What is used for the deactivation and decontamination?

A

2% bleach (sodium hypochlorite) or peroxide

47
Q

What is used for cleaning?

A

germicidal detergent: Quat, ammonium, phenolics

48
Q

what is used for disinfection?

A

70% IPA

49
Q

What is the product that combines the deactivation and decontamination step?

A

period RTU or bleach

50
Q

What is the complexity of this CSP?

requires compounding a preparation that has NO established stability data or a preparation with specialized calculations or procedures

mixing two topical ingrediatins without stability data for either

A

moderate

vs. simple and complex

51
Q

How is hazardous waste disposed

A

put into a trash waste bad and sealed. this is BULK hazardous waste which is discarded in the black bulk hazardous waste bin

52
Q

how many gloves should be worn when administering HDs

A

two

And a gown is required when administering IV HD, but recommended for oral HD

53
Q

what must be used for nurses for drug administration for IV HD

A

closed system drug transfer devices (CSTDs)

recommended when compounding

54
Q

bulk antineoplastic waste goes where?

A

BLACK container

55
Q

Single gloves with HD can be worn when

A

receiving and storage

double for compounding or cleaning

56
Q

If a BSC or CACI is not available then PPE should be used that includes

A

double gloves

a gown

mask

disposable pad to protect work surface

57
Q

PPE for sterile HD compounding includes

A 
head cover
face mask cover
beard cover
two pairs of shoes
a gown impeccable to lquids
two pairs of ASTM D6978 rated gloves
full face piece respirator or a face shield with goggles

NAPLEX 21 (60 decks)

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