USP 797

IV Hospital Lab

Who is responsible for enforcing compliance with USP 797 standards?

FDA, The Joint Commission, and State BOP

Anteroom

transition room between unclassified environment and the buffer room; maintains ISO class 8 or better; hand washing, garments, and PPE (except gloves) are done here

Buffer room

room that houses the primary engineering control (hood/workbench); maintains ISO class 7 or better; sterile gloves are put on here

Cleanroom Suite

combination of the anteroom and buffer room

Direct compounding area

critical area within hood/workbench where compounding occurs; all critical sites must be exposed to first air in this area; must be at least 6 inches from all sides of PEC

ISO class

air quality classification which defines the number of particles per cubic meter allowed - the smaller # classified, the fewer particles allowed per cubic meter

Primary Engineering Control (PEC)

the laminar flow workbench (aka hood) which maintains ISO class 5 or better; where sterile compounding occurs

Secondary Engineering Control (SEC)

the room which houses the PEC; in most cases, this is the same as the buffer room

Segregated Compounding Area (SCA)

designated and clearly marked space which is not classified but houses a PEC. Only category 1 CSP may be compounded in this area

A PEC maintains an ISO Class __ environment

5

What is the difference between a horizontal laminar airflow workbench (HLFW) and a vertical laminar airflow workbench (VLFW)?

only the direction of the laminar flow coming from the HEPA filter

What type of laminar airflow workbench can you compound hazardous drugs? Why?

Biological Safety Cabinet; it has a glass shield that provides sterility for the drug and the compounder

First Air

the air that exits directly from the HEPA filter in a laminar airflow workbench

Zone of Turbulence

Areas in the Laminar airflow workbench where the airflow is interrupted and is no longer “first air”

The Direct Compounding area within a workbench must be a minimum of __ inches from all sides of the PEC

6

Cleaning vs Disinfecting

Cleaning: removing substances from surfaces (ex. dirt, debris, chemicals, etc.)

Disinfecting: using chemicals to destroy fungi, viruses, bacteria, and spores

Immediate use CSP

in hospital settings, prepared in OR or at bedside in emergencies

• aseptic technique

• no more than 3 sterile ingredients

• BUD 4 hours

Classified CSP

Category 1, 2, or 3 - based on environment in which they are compounded

aseptic technique used in all categories

differ in probability of microbial growth and BUD

Which category of classified CSP is compounded in the least controlled environment and has the shortest BUD?

Category 1

Where is a category 1 CSP compounded?

in a PEC, but the PEC can be in a segregated compounding area

Which Category of CSP must be compounded in a cleanroom suite? (We use this in lab)

Category 2

Which category CSP undergoes sterility testing after being compounded?

Category 3

what is the date and time after which a CSP must not be used, stored, or transported? (this is different than an expiration date of a medication)

Beyond Use Date (BUD)

What is the max BUD for an immediate use CSP at room temp? (only if you cannot find it online)

4 hours

What is the max BUD for a category 1 CSP stored in the fridge? (only if you cannot find it online)

24 hours

What is the max BUD for a category 2 CSP stored at room temp? (only if you cannot find it online)

4 days

What is the max BUD for a category 2 CSP stored in the fridge? (only if you cannot find it online)

10 days