Sterile Compounding (Ch5 Rx17) Flashcards
What ISO air rating must critical areas that are closest to exposed sterile drugs and containers be? (Rx17)
ISO 5
What is PEC? (Rx17)
- Primary Engineering Control
2. Provides the ISO class 5 space
List ISO air rating from cleanest to dirtier air (Rx17)
ISO 5 (PEC cleanest), 6, 7, 8, unclassified air (regular room air)
What is the buffer area? ISO? (Rx17)
- Area where the PEC is located
- Sometimes called the IV room
- Must have at least ISO 7 or better (lower than 7)
What is the ante area (anteroom)? ISO? (Rx17)
- Directly adjacent to the buffer area
- Where hand washing and garbing is done
- If it opens to positive pressure buffer area = ISO 8
- If it opens to negative pressure buffer area = ISO 7
What is a biological safety cabinet? (Rx17)
- Negative pressure hood
2. AKA chemo hood
What is a line of demarcation? (Rx17)
A line that separates the ante area and buffer area
In a horizontal hood, nothing should be place where regarding a sterile object? (Rx17)
- Nothing should be behind a sterile object
2. Ensure the sterile items receive the first air
In a vertical hood, nothing should be placed where regarding a sterile object? (Rx17)
- Nothing should be above the sterile object
2. Ensure the sterile items receive the first air
What is the osmolarity of human blood? (Rx17)
285 mOsm/L
What is the pH of blood? (Rx17)
Slightly alkaline, pH 7.35-7.45
What type of recall has a reasonable probability that the use or exposure will cause serious adverse health consequences or death? (Rx17)
Class I Recall
How does a compounder typically extract from vials that contain liquids? (Rx17)
- Usually injects a volume of air equal to the volume of the drug that is withdrawn
- This is not done for hazardous drugs
What are the USP guidelines for assigning BUD for low risk compounding? (Rx17)
- Room temp = 48 hours
- Fridge temp = 14 days
- Freezer temp = 45 days (same for all risk levels)
