Compounding I: Basics

Question 1

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

Answer 1

SDS “safety data sheets”

Question 2

Where are powders made?

Answer 2

in a powder containment hood

“Ventilated compounding enclosure”

Question 3

The sterile compounding space must include an”

Answer 3

anteroom

buffer area

primary engineering control or a segregated compounding area

Question 4

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

Answer 4

containment “C-PEC, C-SEC”

Question 5

The C-sec must contain what type of ISO

Answer 5

ISO 7

Question 6

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

Answer 6

1 meter

Question 7

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

Answer 7

negative

Question 8

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

Answer 8

negative, 12

Question 9

Sterile HD ACPH=

Answer 9

30 ACPH

Question 10

non-sterile HD ACPH=

Answer 10

12 ACPH

Question 11

What is used when external venting is not reasonable

Answer 11

Redundant HEPA filters

*can only be used for non-sterile HD

Question 12

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

Answer 12

primary engineering control (PEC)

Question 13

The buffer room or sterile compounding room

Answer 13

SEC

Question 14

The isolator

Answer 14

compounding aseptic isolator

Question 15

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

Answer 15

Class II biological safety cabinet (BSC)

Question 16

The isolator glove box for HDs

Answer 16

compounding aseptic containment isolator

Question 17

The room where the C-PEC Is located is called

Answer 17

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

Question 18

IV container up to 100mL

Answer 18

small parenteral

> 100mL is large

Question 19

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

Answer 19

5

0.5m

Question 20

ISO rating: PEC

Answer 20

5

3520 particles

Question 21

ISO rating: SEC/buffer room

Answer 21

ISO 7

352000

Question 22

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

Answer 22

7

same ISO # as the SEC

Question 23

Ante room if it opens into a positive pressure SEC

Answer 23

8

Question 24

Biological Safety Cabinet (BSC) =

Answer 24

the C-PEC

Question 25

Laminar airflow workbench =

Answer 25

PEC

Question 26

What is first air?

Answer 26

air from the HEPA filter checked every 6 months

Question 27

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

Answer 27

line of demarcation

Question 28

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

Answer 28

negative for others it doesn't matter

Question 29

What is the compounding aseptic isolators?

Answer 29

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"

Question 30

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

Answer 30

12 hours

Question 31

in a positive pressure area the ISO must be

Answer 31

8

Question 32

in a negative pressure area the ISO must be

Answer 32

7

Question 33

What is the color of the waste bucket for non hazardous

Answer 33

red sharps and non HD waste

Question 34

color of the waste bucket for hazardous

Answer 34

yellow trace HD waste - vials and syringes

Question 35

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

Answer 35

tryptic soy agar (TSA) ``` CFU = contaminated passing = 3 consecutive passes ```

Question 36

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

Answer 36

tryptic soy broth pass = clean for 14 days

Question 37

how often should the temp be monitored

Answer 37

once daily in the SEC should be 68 or cooler

Question 38

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

Answer 38

daily vaccines = twice daily

Question 39

air sampling should be performed

Answer 39

every 6 months

Question 40

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

Answer 40

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

Question 41

air pressure testing every

Answer 41

once daily or every work shift

Question 42

What is cleaned every day?

Answer 42

counters floors carts

Question 43

cleaned weekly?

Answer 43

``` walls windows shelving bins chairs ```

Question 44

Monthly cleaning?

Answer 44

ceiling

Question 45

What are the steps to cleaning

Answer 45

deactivation and decontamination cleaning disinfection

Question 46

What is used for the deactivation and decontamination?

Answer 46

2% bleach (sodium hypochlorite) or peroxide

Question 47

What is used for cleaning?

Answer 47

germicidal detergent: Quat, ammonium, phenolics

Question 48

what is used for disinfection?

Answer 48

70% IPA

Question 49

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

Answer 49

period RTU or bleach

Question 50

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

Answer 50

moderate | vs. simple and complex

Question 51

How is hazardous waste disposed

Answer 51

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

Question 52

how many gloves should be worn when administering HDs

Answer 52

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

Question 53

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

Answer 53

closed system drug transfer devices (CSTDs) recommended when compounding

Question 54

bulk antineoplastic waste goes where?

Answer 54

BLACK container

Question 55

Single gloves with HD can be worn when

Answer 55

receiving and storage double for compounding or cleaning

Question 56

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

Answer 56

double gloves a gown mask disposable pad to protect work surface

Question 57

PPE for sterile HD compounding includes

Answer 57

``` 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 ```