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45 Cards in this Set

  • Front
  • Back

Ante (ante room)

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

Buffer area

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

Biologically safety cabinet

the "hood" and is located in the clean room


Compounded sterile preparations (the IV drugs made in the


positive pressure

keeps contaminated air from entering the hood to protect the CSP

from contamination

negative pressure

For hazardous drugs and keeps contaminated air away from the

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

ISO classification

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

ISO 5 is used for..

All primary engineering controls (PECs)

ISO 7 is used for..

1) the buffer area

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

ISO 8 is used for

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


CSP low risk - BUDs and location

BUD room temp - 48 hours

BUD refrig - 14 days

BUD frozen - 45 days

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

CSP low risk with < 12-hr BUD

BUD room temp and refrig - 12 hours

BUD frozen - N/A

Location: ISO 5 segregated from other operations

CSP medium risk BUD and location

BUD room temp - 30 hours

BUD refrig - 9 days

BUD frozen - 45 days

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

CSP high risk BUD and location

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

CSP immediate use BUD and location

BUD room temp - 1 hour

BUR refrig and freezer - N/A

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

Osmolarity of human blood

285 mOsm/L

Types of sterility testing for high risk CSPs

1) tryptic soy broth (TSB)

2) fluid thipglycollate medium (FTM)

AND should include bacterial endotoxin (pyrogen) testing prior to


Type of sterilization for high risk CSPs

terminal sterilization with pressurized steam sterilization using autoclave

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

(hormones, proteins)

filtration with a 0.22 micron filter

*test filter integrity with the bubble-point test

Type of sterilization used for products that can be damaged by


dry heat sterilization

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

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

protection for staff

Cleaning laminar flow hoods

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

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

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

6 inches

In what kind of hood should chemotherapy be prepared?

vertical hood

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

germicidal detergent

What type of water should be used for cleaning sterile

compounding areas?

sterile water followed by 70% IPA

the order of cleaning in the sterile

compounding areas

from cleanest to dirtiest.

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

Buffer area cleaning schedule

At the beginning of each shift

Before and after each batch

After spills

Every 30 minutes of continuous use

Anytime contamination is suspected

Counters, work surfaces and floors cleaning schedule


Walls, ceilings and storage shelves cleaning schedule


When is regard required?

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

When and which garb can be reused?

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


By whom can recalls be initiated?

FDA request

FDA order under statutory authority

Company's initiative

Class I Recall

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

Ex: morphine tablet manufactured with 10x of active ingredient

Class II Recall

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

Class III Recall

Use or exposure is not likely to cause adverse health


Ex: the coloring on tablets may have been applied inconsistently

Each facility that does sterile compounding must have a quality

assurance plan that should minimally include: (3)

1. Personnel training and assessment

2. Environmental monitoring

3. Equipment calibration and maintenance

Endotoxins are produced by..

both GP and GN bacteria and fungi

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

Limulus Amebocyte Lysate (LAL) which is based on clotting

properties of the horseshoe crab's blood

temperature monitoring

(sterile compounding) frequency

daily (at a minimum)

frequency of qualified certifier must certify the area

(sterile compounding)

every 6 months (semi-annually)

frequency of air sampling by compounding personnel or cerifier

(Sterile compounding)

at least every 6 months

frequency of gloved fingertip sampling

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

verify at initial training

low and medium risk (annually)

high risk (semi-annually)

frequency of surface sampling (sterile compounding)


frequency of HEPA filter pressure (sterile compounding)

each shift (preferably) or daily (minimally)