United States Pharmacopeia 800: Hazardous Pharmaceuticals Part 2

Question 1

HD sterile compounding must take place in an ISO class ____ or better environment

Answer 1

5

Question 2

Acceptable C-PECs for compounding of HDs are Class II biologic safety ____ (BSC) or Compounding aseptic containment isolators (CACI)

Answer 2

cabinets

Question 3

The C-PECs must be placed in a ____ room (C-SEC).

Answer 3

containment secondary engineering control

Question 4

C-SEC air exchanges need at least ____ air changes per hour and externally vented

Answer 4

12

Question 5

C-SEC must have fixed walls in the ISO class ____ room

Answer 5

7

Question 6

You must monitor ____, ____, and ____ with C-SECs

Answer 6

air exchanges, temperature, and humidity

Question 7

A sink must be placed at least ____ meter from the entrance to the negative pressure buffer room

Answer 7

one

Question 8

A Closed-system drug transfer device (CSTD) protects the compounder from exposure to ____ when the medication is withdrawn from a vial.

Answer 8

aerosols