Week 3

Question 1

Define US Pharmacopeia

Answer 1

Established standards for the identity, strength, quality and purity of meds, food ingredients and dietary supplements

Question 2

Who enforces the US Pharmacopeia?

Answer 2

FDA

Question 3

Define Chapter 797

Answer 3

Compounding sterile products

= Set standards that are applicable to all places that prepare sterile products

Question 4

Purpose of the 797

Answer 4

To protect the health of pts by reducing contamination possibilities

Question 5

States indirect mean:

Answer 5

Do not specifically site USP 797 but there are laws and regulation for sterile compounding

Question 6

797 includes:

Answer 6

Garbing requirements
Hand washing
Room requirements
Training
Cleaning
Testing of the environment

Question 7

Define International Organization of Standardization (ISO)

Answer 7

Ensure that products and services are safe, reliable and of good quality

Question 8

ISO 5 Particle limit

Answer 8

3520

~100 ft^3

Question 9

ISO 7 Particle Limit

Answer 9

352000

~10000 ft^3

Question 10

ISO 8 Particle Limit

Answer 10

3,520,000

~ 100,000 ft^3

Question 11

ISO Class 5 is required where?

Answer 11

LAFW, biological safety cabinet, compounding aseptic containment isolator, compounding aseptic isolator
HEP filtered unidirectional airflow
Hoods

Question 12

ISO Class 7 is required where?

Answer 12

Buffer room

Hood room

Question 13

ISO Class 7 is required where?

Answer 13

Ante area
Where you waash your hands and put on PPE
Clean supplies

Question 14

What do you see in the Ante area?

Answer 14

Sink
Supplies
Hand dryer/paper towels

Question 15

What do you do in the Ante area?

Answer 15

Wash hands and put on garb

Open and clean supplies

Question 16

What do you see in buffer area?

Answer 16

Smooth and continuous surfaces
No sinks, drains, outer doors, opening windows
Hoods, minimal supplies and pumps
Control of humidity, temperature, pressure

Question 17

Buffer areas should have _____ pressure which ___________.

Answer 17

Positive; pushes air out of the room

Question 18

Unless ___________ then it has to have negative pressure.

Answer 18

Chemo buffer room

Question 19

What do you do in the buffer area?

Answer 19

Prepare for compounding

Question 20

What do you see in the Hood?

Answer 20

Easily cleanable surfaces
Minimal supplies
Light/UV light
Pole with hooks
Electric plugs
Filter

Question 21

What do you do in the hood?

Answer 21

Compound

Question 22

Risk level is assigned according to the probability of contaminating a compounded with:

Answer 22

Microbial contaminants

Physical and chemical contaminants

Question 23

Low Risk Max Room Temp

Answer 23

48 hours

Question 24

Low Risk Max Refrigerated

Answer 24

14 days

Question 25

Low Risk Max Frozen

Answer 25

45 days

Question 26

Low risk requirements

Answer 26

ISO class 5 within an ISO class 7 with an ISO class 8 ante area <2 entries Annual media fill test

Question 27

Low Risk

Answer 27

``` ISO Class 5 Nonhazardous Admin is no later than 12 hours after Segregated compounding area Cleansing and garb required ```

Question 28

Medium Risk room temp

Answer 28

30 hours

Question 29

Medium Risk refrigerated

Answer 29

9 days

Question 30

Medium Risk frozen

Answer 30

45 days

Question 31

Medium Risk Requirements

Answer 31

>3 sterile products >2 entries Annual Media Fill-Test

Question 32

High Risk Requirements

Answer 32

Nonsterile | Biannual Media Fill Test

Question 33

High Risk room temp

Answer 33

24 hrs

Question 34

High risk refrigerated

Answer 34

3 days

Question 35

High risk frozen

Answer 35

45 days

Question 36

Immediate use requirements

Answer 36

<1 hr after making

Question 37

Single dose BUD

Answer 37

1 hr if not in hood | 6 hr if in hood

Question 38

Multiple-dose containers BUD

Answer 38

28 days

Question 39

Define Hazardous Drug

Answer 39

Chemo or any IV drug that may put the compounding personnel at risk Stored separate in well ventilated area (12 air changes per hour)

Question 40

Hazardous Drugs Buffer area vs ante

Answer 40

``` ISO class 7 with negative pressure ISO class 8 with positive pressure ```

Question 41

Personnel must be trained in

Answer 41

Safe aspetic manipulation Negative pressure techniques Correct use of closed system vial transfer device Containment, cleanup and disposal for spills and breakage Treatment of personnel contact and inhalation

Question 42

Re-certification of facilities and equipment and nonviable air sampling occurs?

Answer 42

Every 6 months

Question 43

Must also do

Answer 43

Viable air sampling and have a pressure gauge