compounding I basics Flashcards
what area needs to be ISO 5
PEC- called the sterile hood or isolater in a glove box <3520 particles
what area should be ISO 7
SEC called the buffer room <352000 particles
ante room only if it opens into a negative pressure
Hepa filter can remove what size particle
As small as 0.3 microns
recertification of HEPA filter is done every
6 months and anytime a PEC is moved
how to prevent contamination in the PEC
wipe the outside with 70% alcohol
open packages along the tear line
compound atleast 6 inches inside the sterile hood
remove waste asap
positive vs negative airpressure
positive is to keep contamination away- non hazardous
negative is to keep harmful drugs reaching staff- hazardous
Stat compounds have a BUD of
1 hour
what is the BUD for a Segregated compounding area sterile compound
12 hours
who determines drugs are hazardous
NIOSH- national institute for occupational safety and health
Hazardous substance need what requirement by OHSA
SDS
- PPE, first aid procedure, spill clean up procedure
SOP
standard operating procedure- designated individual
hazardous requirements for compounding
Negative pressure
CPEC, CSEC, CSCA, CACI
class II (most common) or class III BSC
if non sterile and sterile are together what are the rules
CSEC must maintain ISO7
1 meter apart
for non sterile 12 ACPH
for sterile 30 ACPH
CSCA- 12 ACPH
HD- external exhaust is required or redundant HEPA filters
what are the training requirements for compounding staff
initial training- didatic and hands on training
continuous training
for sterile compounding required training includes
- hand hygiene
- garbing and gloving technique
- cleaning and disinfecting procedures
- sterile drug prep
* fingertip test - initial test adn then annual for low to medium and 2 times for high risk ( 3 tests per test)
* media fill test
temperature monitoring rule
log sheet every day- SEC room 20d Cor 68 F
vaccine require 2 times a day log
refrigerator 2-8 C
freezer with no vaccine -25 to -10C
freezer with vaccine -50 to -15
