Chapter 15: Compounding I: Basics Flashcards
Who sets the standards for compounding preparations, strength, quality and purity of human and animal drugs?
US Pharmacopeia (USP)
Which USP chapter is related to non-sterile compounding?
USP 795
Which USP chapter is related to sterile compounding?
USP 797
Which USP chapter is related to handling hazardous drugs?
USP 800
Who determines which drugs are hazardous?
The National Institute for Occupational Safety and Health (NIOSH)
Besides USP chapters, where else can pharmacists find detailed guidance on implementing USP standards?
American Society of Health-System Pharmacists (ASHP)
What are the 4 characteristics that make a drug hazardous?
- Carcinogenic
- Teratogenic
- Causes organ toxicity at low doses
- Genotoxic (damages the DNA)
What must be included in a sterile compounding space?
- anteroom
- buffer area
- primary engineering control (PEC) or a segregated compounding area (SCA)
What requirements must be met for a non-sterile HD to be prepared in a C-PEC inside a C-SEC?
- The C-SEC must maintain ISO 7 air
- There must be separate sterile and non-sterile C-PECs kept at least 1 meter apart
- Particle-generating activity, such as working with powders, cannot be performed when any sterile compounding is being performed in the same C-SEC
C-PECs (containment primary engineering control) and C-SECs (containment secondary engineering control) must have ______
negative air pressure
In space where non-sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)
12
In space where sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)
30
What does it mean when air that has been contaminated with HDs must be externally exhausted?
The air is moved out of the space and cannot be recirculated and returned to the room
What is an alternative option to an external exhaust (for non-sterile HD compounding only)
Redundant-HEPA filters
What is a primary engineering control (PEC)?
The sterile hood
What is a secondary engineering control (SEC)?
The buffer room or sterile compounding room (the C-PEC is placed here)
What is a class II biologic safety cabinet (BSC)
The chemo hood for sterile chemo drugs and other sterile HDs (aka a C-PEC)
What is a Compounding Aseptic Containment Isolator (CACI)
The isolator glove box for HDs
CAI is for non-HD
The International Standards Organization (ISO) sets the standards for air quality, which is determined by the number and size of ___ per ___ of air
Particles per volume (the lower the particle count, the cleaner the air)
In critical areas that are closest to exposed sterile drugs and containers (i.e. inside the sterile hood) the air must be at least ISO __. Particles are included in this count if they are ____ in size or larger
5
0.5 microns
The buffer area (or SEC) must be at least ISO __
7
The anteroom (the room adjacent to the SEC, where hand washing and garbing occurs) must be at least ISO __ if it opens into a positive-pressure buffer area (non-HD sterile compounding) or at least ISO __ if it opens into a negative-pressure buffer area (HD sterile compounding)
8
7
HEPA filters are >99.97% efficient in removing particles as small as ____ wide or larger, including bacteria, fungi, viruses, and dust
0.3 microns
In a ___ airflow biologic safety cabinet (BSC) or C-PEC, the HEPA filter is at the top of the sterile hood
Vertical