Rxprep Chapter 4 Sterile Compounding

Front 1

Ante (ante room)

Back 1

space outside the sterile compounding area where the sink and

garbing items are located. Garbing and hand washing must be done in the ante room

Front 2

Buffer area

Back 2

"Cleanroom". This is where the sterile compounding takes place

Front 3

Biologically safety cabinet

Back 3

the "hood" and is located in the clean room

Front 4

CSP

Back 4

Compounded sterile preparations (the IV drugs made in the

cleanroom)

Front 5

positive pressure

Back 5

keeps contaminated air from entering the hood to protect the CSP

from contamination

Front 6

negative pressure

Back 6

For hazardous drugs and keeps contaminated air away from the

compounding staff and from exiting the hood. The air is vented to the outside.

Front 7

ISO classification

Back 7

Refers to the number of particles that are permitted per volume of air. The smaller the number the cleaner the air

Front 8

ISO 5 is used for..

Back 8

All primary engineering controls (PECs)

Front 9

ISO 7 is used for..

Back 9

1) the buffer area

2) the ante area if it opens into a negative pressure cleanroom

Front 10

ISO 8 is used for

Back 10

the ante area if it opens only into a positive pressure ISO 7

cleanroom

Front 11

CSP low risk - BUDs and location

Back 11

BUD room temp - 48 hours

BUD refrig - 14 days

BUD frozen - 45 days

Location: ISO 5, ISO 7 buffer area, ISO 8 ante area

Front 12

CSP low risk with < 12-hr BUD

Back 12

BUD room temp and refrig - 12 hours

BUD frozen - N/A

Location: ISO 5 segregated from other operations

Front 13

CSP medium risk BUD and location

Back 13

BUD room temp - 30 hours

BUD refrig - 9 days

BUD frozen - 45 days

Location: ISO 5, ISO 7 buffer area, ISO 8 ante area

Front 14

CSP high risk BUD and location

Back 14

BUD room temp - 24 hours

BUD refrig - 3 days

BUD frozen - 45 days

Location: ISO 5 PEC, ISO 7 buffer area, ISO 8 or better ante area

Front 15

CSP immediate use BUD and location

Back 15

BUD room temp - 1 hour

BUR refrig and freezer - N/A

Location: "Clean, uncluttered, functionally separate area" per USP

Front 16

Osmolarity of human blood

Back 16

285 mOsm/L

Front 17

Types of sterility testing for high risk CSPs

Back 17

1) tryptic soy broth (TSB)

2) fluid thipglycollate medium (FTM)

AND should include bacterial endotoxin (pyrogen) testing prior to

use

Front 18

Type of sterilization for high risk CSPs

Back 18

terminal sterilization with pressurized steam sterilization using autoclave

Front 19

Type of sterilization for high risk CSPs that are heat-labile

(hormones, proteins)

Back 19

filtration with a 0.22 micron filter

*test filter integrity with the bubble-point test

Front 20

Type of sterilization used for products that can be damaged by

moisture

Back 20

dry heat sterilization

Front 21

Vertical flow hood (aka biological safety cabinets or chemotherapy hoods) flow..

Back 21

air is blown from the top down to maintain sterility and provide

protection for staff

Front 22

Cleaning laminar flow hoods

Back 22

daily all surfaces are cleaned with 70% isopropyl alcohol in a

side-to-side motion starting from the back of the hood

Front 23

How many in. from the front edge of the hood should be clear?

Back 23

6 inches

Front 24

In what kind of hood should chemotherapy be prepared?

Back 24

vertical hood

Front 25

What disinfectant should be used fore cleaning and disinfecting the sterile compounding areas?

Back 25

germicidal detergent

Front 26

What type of water should be used for cleaning sterile

compounding areas?

Back 26

sterile water followed by 70% IPA

Front 27

the order of cleaning in the sterile

compounding areas

Back 27

from cleanest to dirtiest.

buffer area-->ante area-->general supply area

Front 28

Buffer area cleaning schedule

Back 28

At the beginning of each shift

Before and after each batch

After spills

Every 30 minutes of continuous use

Anytime contamination is suspected

Front 29

Counters, work surfaces and floors cleaning schedule

Back 29

daily

Front 30

Walls, ceilings and storage shelves cleaning schedule

Back 30

monthly

Front 31

When is regard required?

Back 31

When the garb is exposed to less than ISO 8 conditions (garb is not supposed to be worn outside ante room)

Front 32

When and which garb can be reused?

Back 32

The gown can be reused for the same shift if the person did not

leave the ante room

Task-specific eye wear and dedicated shoes may be reused and

kept in the ante room and routinely cleaned with germicidal

disinfectant

Front 33

By whom can recalls be initiated?

Back 33

FDA request

FDA order under statutory authority

Company's initiative

Front 34

Class I Recall

Back 34

Reasonable probability that the use or exposure will cause serious adverse health consequences or death.

Ex: morphine tablet manufactured with 10x of active ingredient

Front 35

Class II Recall

Back 35

Use or exposure can cause temporary or reversible adverse

events or the probability of harm is remote.

Ex: ketorolac inj have been recalled in 2010 and 2015 due to

possibility of particles in the vials

Front 36

Class III Recall

Back 36

Use or exposure is not likely to cause adverse health

consequences

Ex: the coloring on tablets may have been applied inconsistently

Front 37

Each facility that does sterile compounding must have a quality

assurance plan that should minimally include: (3)

Back 37

1. Personnel training and assessment

2. Environmental monitoring

3. Equipment calibration and maintenance

Front 38

Endotoxins are produced by..

Back 38

both GP and GN bacteria and fungi

Front 39

The reagent for the bacterial endotoxins test (BET) is called...

Back 39

Limulus Amebocyte Lysate (LAL) which is based on clotting

properties of the horseshoe crab's blood

Front 40

temperature monitoring

(sterile compounding) frequency

Back 40

daily (at a minimum)

Front 41

frequency of qualified certifier must certify the area

(sterile compounding)

Back 41

every 6 months (semi-annually)

Front 42

frequency of air sampling by compounding personnel or cerifier

(Sterile compounding)

Back 42

at least every 6 months

Front 43

frequency of gloved fingertip sampling

passing requires 3 samples (2 plates each) with zero CFUs

Back 43

verify at initial training

low and medium risk (annually)

high risk (semi-annually)

Front 44

frequency of surface sampling (sterile compounding)

Back 44

periodically

Front 45

frequency of HEPA filter pressure (sterile compounding)

Back 45

each shift (preferably) or daily (minimally)