Compounding pt 2 Flashcards
Medications that must be prepared in a sterile manner include…
opthalmics, inhalations, (irrigations), and IV medications
How is air quality defined?
Number of particles per volume of air
Defined by ISO
What ISO rating corresponds to the different compounding areas
Primary engineering control = 5 Buffer area (air in room around PEC) = 7 Garbing area (ante area) = 7 if opens into negative pressure, 8 if opens into positive pressure
What is primary engineering control vs secondary engineering control
PEC = isolator or hood, ISO Class 5 SEC = ante area and buffer area (ranges 7-8)
Ante area must have how many air changes per hour
30
What is laminar airflow?
Air flows in the same direction at the same speed in parallel lines
In a horizontal LAFW, nothing should be _____ the sterile object
Behind
In a vertical LAFW, nothing should be _____ the sterile object
Above
Why is it important that nothing be behind (horizontal LAFW) or above (vertical LAFW) sterile objects?
To ensure they receive “first air” that comes out of the HEPA filter
What are BSC’s?
Biological safety cabinets
They are used to compound chemo and other hazardous drugs
They are negative pressure, vertical laminar hoods that limits staff exposure to toxic drugs
Describe isolators
“Glove boxes”
Hazardous drugs can be compounded in aseptic containment isolaters (CACI’s) which have negative pressure
Non hazardous drugs can be used in aseptic isolaters (CAI’s) which have positive pressure
Options for pharmacies that do not have room for a full IV room?
Use segregated compounding area
Unclassified air, BUD is 12 hours
What is the glove fingertip test?
Used to evaluate gloving and garbing technique
Passing requires 3 consecutive gloved fingertip samples with zero CFU’s for both hands
Required annually for personnel who compound low or medium risk CSPs
Required semiannually for those who compound high risk CSPs
How should surfaces be cleaned?
With germicidal detergent and disinfected with 70% isopropyl alcohol
Clean from cleanest to dirtiest (buffer area, then ante area, then general supply area)
When cleaning hood: top to bottom, back to front, cleanest to dirtiest
- Ceiling (back to front)
- Grill (top to bottom)
- Side walls (back to front, wiping up and down) including IV bar and hooks
Non-PVC bags should be used for medications that have…
Leaching or sorption issues
What is the bubble point test?
Used to test filtering
Uses pressure to force liquid to “bubble” our of the filter to test filter integrity
Which CSPs require sterility testing? How is it performed?
Certain high risk CSPs and CSPs intented for use beyond the recommended BUD
Use either tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endodoxin (pyrogen) testing prior to use
What is a class I vs class II vs class III recall
Class I = reasonable probability that use or exposure will cause serious adverse health consequences or death
Class II = can cause temporary or reversible adverse health consequences
Class III = use or exposure is not likely to cause adverse health consequences
Hood has to be on for how many minutes before it can be used?
30 minutes
What special care should be used when injecting an IV bag with drug from an ampule?
Use a standard needle to draw up the medication from the ampule, but then discard the needle and change to one with a filter device before injecting into IV bag (to avoid any glass particles entering the admixture)
Correct way to verify IV bag correct volumes were mixed
BEFORE the drug is injected into the bag
“syringe pull back method” is not recommended by ISMP or addressed by USP
Pharmacist should verify that the volume of drug pulled back in the syringe is correct before it is injected in the bag
How is a BUD determined?
USP 797 standards and the stability/expiration date of the individual ingredients, whichever is shorter
A sterility test can be performed to determine if a longer BUD is possible
USP 797 standards determine BUD by CSP risk level and storage temperature
Low risk BUD
Room temp 48 hours
Fridge temp 14 days
Freezer temp 45 days
Low non-HD risk BUD
All 12 hours
