notes

Question 1

what types of medications must be prepared in a sterile manner?

Answer 1

ophthalmics, inhalations, irrigations, IVs

Question 2

BUD in sterile compounding

Answer 2

lower the risk of contamination, longer the BUD

if refrigerated - BUD 14 days

Question 3

ISO air quality in sterile compounding

Answer 3

the number of particles per volume of air of a specified particle size

the lower the count, the cleaner the air

Question 4

What must the ISO be in the compounding area?

Answer 4

primary engineering control (PEC): at least 5 - 3,520
buffer area (area in room around PEC): at least 7 - 35,200
ante room if positive pressure into buffer area: 8 - 352,000
ante room if negative pressure into buffer area: 7 - 3,520,000

Question 5

what do you clean the inside of PEC with?

Answer 5

sterile IPA 70%

sterile lint-free wipes

Question 6

at least how many air changes per hour does the PEC in an buffer room have to be for a compounded sterile product to be made?

Answer 6

at least 30 air changes per hour

Question 7

what kind of devices are PECs?

Answer 7

ventilation devices

Question 8

the laminar airflow workbench is for what type of CSP?

Answer 8

non-hazardous

Question 9

what is laminar airflow

Answer 9

smooth unidirectional airflow in parallel lines to prevent particles from hitting each other and landing on surfaces

Question 10

what is the airflow direction of the laminar hood?

Answer 10

horizontal (back of hood to front)

vertical (above to down)

Question 11

where should products not be placed in a vertical or horizontal hood.

Answer 11

horizontal: nothing should be behind
vertical: nothing should be above

Question 12

compounding is done in the cleanest part of the hood, which is where?

Answer 12

~6 inches from the front of the hood

Question 13

what are biological safety cabinets?

Answer 13

They are for hazardous or chemo drug compounding and are negative pressure and have a vertical laminar hood

Question 14

what are isolators?

Answer 14

“glove-boxes”

Question 15

which types of isolators should be used for hazardous and non-hazardous drugs?

Answer 15

hazardous: compounded aseptic containment isolators which have negative pressure
non-hazardous: compounded aseptic isolators which have positive pressure

Question 16

drugs made in the segregated compounding area have what BUD?

Answer 16

<=12 hours

Question 17

what is the gloved fingertip test?

Answer 17

it is to evaluate gloving and garbing techniques.

A pass is three consecutive gloved fingertip tests with zero CFUs.

Question 18

How often should a gloved fingertip and media-fill test be conducted?

Answer 18

low to medium risk compounding - annually

high risk compounding - semiannually

Question 19

what is the media-fill test?

Answer 19

to evaluate the aseptic technique of personnel.

a fail is if the media becomes turbid at or before 14 days

Question 20

cleaning and disinfecting surfaces is done with what and how?

Answer 20

cleanest to the dirtiest area and with 70% isopropyl alcohol

Question 21

how often should the work surfaces, floors, and counters of the compounding area be cleaned?

Answer 21

daily

Question 22

how often should the PEC be cleaned?

Answer 22

at the beginning of shift
every 30 minutes of continuous use
after spills
whenever contamination is suspected
before and after each batch

Question 23

how often should the ceilings, walls and storage shelves be cleaned?

Answer 23

monthly

Question 24

what do IV solutions need to be?

Answer 24

isotonic
pH close to neutral
in non-PVC bags if leaching or sorption issues

Question 25

what is osmolarity of human blood?

Answer 25

285 mOsm/L

Question 26

how can heat labile CSPs be sterilized?

Answer 26

filtration through a 0.22 micron filter

Question 27

what is the bubble-point test?

Answer 27

a test used to test the integrity of the 0.22 micron filter

Question 28

when is sterility testing of CSP needed?

Answer 28

for certain high risk CSP or if a CSP is intended to be used beyond the beyond use date

Question 29

what is sterility testing conducted on?

Answer 29

tryptic soy broth (TSB) or fluid thioglycollate medium (FTM)

Question 30

what must also be included in the sterility test?

Answer 30

bacterial endotoxin (pyrogen) test

Question 31

how should glassware and utensils be sterilized to prevent bacterial endotoxin?

Answer 31

dry heat sterilization

Question 32

what is the reagent for the bacterial endotoxin test (BET) called?

Answer 32

limulus amebocyte lysate (LAL)

Question 33

what are the environmental monitoring parameters of the sterile compounding area

Answer 33

temperature should be checked daily
air sampling should be done every 6 months
surface sampling should be done periodically (CFU >3 in ISO 5 should be taken action)
air pressure should be done at each shift, daily at the minimum

Question 34

recall classifications

Answer 34

Class I: use or exposure to drug can cause serious AE or death
Class II: use or exposure can cause temporary or reversible AE
Class III: use or exposure is unlikely to cause health concerns

Question 35

what is the order in which the garb should be donned?

Answer 35

dirtiest to cleanest

Question 36

if the hood is turned off, how long does it need to be turned on before use?

Answer 36

at least 30 minutes

Question 37

what kind of compounding is a containment ventilated device used for?

Answer 37

non-sterile compounding