Sterile Compounding (ampoule, vile, chemo)

Question 1

All dosage forms administered by ________ routes must be sterile.

Answer 1

Parenteral

Question 2

Pyrogens can’t form under what 2 conditions?

Answer 2

1. manufactured w sterile components

2. under aseptic conditions

Question 3

Ante room is ______ pressure

Answer 3

positive

Question 4

What’s the line of demarcation

Answer 4

line in ante room that separates dirty and clean side

Question 5

ACHP of ISO 7?

Answer 5

> = 30

Question 6

What is USP <797>?

Answer 6

General sterile compounding, minimum standards to be followed

Question 7

What is USP <795>?

Answer 7

non-sterile compounding

Question 8

What is USP <800>?

Answer 8

hazardous drug compounding

Question 9

What 3 things don’t need to follow <797>?

Answer 9

1. non-hazardous compounded sterile preparation used w/in 1 hour
2. proprietary bag and vial system
3. Allergenic extracts (used to diagnose allergic diseases)

Question 10

How many Colony Forming Units are allowed after garbing and after compounding?

Answer 10

0 and 3

Question 11

Ante-room with access to a positive pressure room = ISO ___ ?

Answer 11

ISO 8

Question 12

CSPs must be prepared in ISO Class ___ ?

Answer 12

ISO 5

Question 13

Negative pressure is when airflow is _______ hood/room and vented to the outside.

Answer 13

out of the hood/room

Question 14

When to clean Primary engineering control?

Answer 14

beginning and end of each shift, after spills, when contamination is suspected

Question 15

What should be cleaned daily? 
A. Counters
B. Walls
C. Doors
D. Ceiling
E. Work surfaces
F. Floors
G. Shelves

Answer 15

A, E, F

Question 16

HEPA facts (%, size, direction, run for how long)

Answer 16

Removes 99.7% of all air particles as small as 0.3 microns. Flows in one direction, constant rate away from CSPs. Nothing should come in contact with HEPA filter. Run 30 mins to re-establish airflow if turned off.

Question 17

What is an SCA?

Answer 17

Segregated Compounding Area. It’s when the PEC isn’t in a clean/buffer room so you designate an area for the CSPs to take place.

Question 18

What’s IVLFZ?

Answer 18

Integrated vertical laminar flow zones

the HEPA filter comes from ceiling, entire room, open architecture

Question 19

What is CACI? What kind of pressure?

Answer 19

Compounding aseptic containment isolators, neg pressure, hazardous drugs, type of RABS

Question 20

SVP/LVP transfter

When you’re adding >10% of the total volume in bag, you should…?

Answer 20

remove equal amount from the bag prior to adding drug

Question 21

T/F You should squeeze hard on IV bags with ports facing down to check for leaks

Answer 21

T

Question 22

What belongs in pharmaceutical waste (black bin)?

Answer 22

UNBROKEN glass w >3% drug remaining
Pure drug powder
NO NEEDLES OR BROKEN GLASS
NO Plain fluid (normal saline, D5W, SWFI), Electrolytes, Parenteral nutrition ingredients (amino acids, dextrose, fats) CUZ THESE GO IN REGULAR TRASH

Question 23

What is the anticoring technique used for?

Answer 23

Penetrating rubber stopper of vial w needle. 45 degree and then 90

Question 24

Standard needle?

Answer 24

1 ½” 19 gauge hypodermic needle

Question 25

Unit for specific gravity

Answer 25

g/ml

Question 26

For emulsions you should use _________ mortar and pestle.

Answer 26

Wedgewood or ceramic. Not glass bc shear is hard to achieve. Glass mortar/pestle not very efficient in reducing particle sizes.