USP 797 and Aseptic Technique Flashcards
what does ISO stand for
international organization of sterilization
ISO classes 5-8
which is the cleanest air quality?
class 5
name what needs to be ISO class 5*
PRIMARY ENGINEERING CONTROL (PEC) — hood, isolator
differentiate between what compounding areas need to be ISO class 7 vs ISO class 8
ISO class 7 - buffer area, and ante area IF it opens into a NEGATIVE PRESSURE room
ISO class 8 - ante area, IF it opens into POSITIVE PRESSURE room
differentiate between the divider between the ante area and buffer area between hazardous vs non hazardous compounding
if doing nonhazardous compounding, there does NOT need to be a physical barrier between the 2
if hazardous, there needs to be a physical separation between the 2 areas
**true or false
the buffer area always needs to be ISO class 7
true
what are secondary engineering controls designed to do?
reduce particles by delivering HEPA filtered air to the room of primary engineering control
*true or false
if positive pressure in the buffer area, the ante area needs to be ISO class 7
FALSE
8
what is the name of the area where personnel hand hygiene and garbing procedures are done?
what else must be done here?
ANTE AREA
supplies must be wiped down with disinfectant before being introduced into buffer area
in which area are the primary engineering controls located
buffer area
how many air changes must the buffer area have per hour?
at least 30
in what area do you put on gloves - ante area or buffer area?
buffer area
in what area do you put on ppe gown - ante or buffer
ante
true or false
when hazardous drugs are being compounded in the buffer area, the ante room must be ISO class 7
true
if non hazardous can be 8
for high risk compounding how often should air pressure differentials be reviewed and documented
how often should walls/storage be cleaned
at least every shift
on a monthly basis
explain what a segregated compounding area is and what the BUD is
designated space for compounding- a satellite phasrmacy. just 1 room. can ONLY prepare non hazardous drugs - no chemo or other hazardous
BUD is much shorter at less than or equal to 12 hours
true or false
for compounding hazardous preparations, clean rooms must be negative pressure
TRUE
if not, usually positive
is flow from buffer to ante or ante to buffer for hazardous/nonhazardous compounding
for hazardous, ante to buffer
(NEGATIVE PRESSURE IN CLEAN ROOM (buffer))
for nonhazardous, buffer to ante (POSITIVE PRESSURE) . buffer area remains clean
*place where sterile compounding personnel can garb and perform aseptic hand washing
ante room
*true or false
a laminar airflow workbench is an example of a secondary engineering control
FALSE
primary
*ante room serves both non hazardous and hazardous buffer area
what ISO for the ante room
7 since it serves both
*remember BUFFER is ALWAYS 7)
which air flow in the laminar air flow work bench is ideal?
VERTICAL
air blows top down to maintain sterility and protect the worker
horizontal would blow at the worker
most common PEC (primary engineering control) for preparing non hazardous sterile preparations
how long should it run prior to use
laminar airflow workbench
at least 30 mis
biological safety cabinets are under what pressure
what are BSC’s used for?
negative pressure
chemotherapy and other hazardous drugs
AND VERTICAL AIR FLOW
differentiate between class 1-3 BSC’s - biological safety cabinets
which will NEVER be used for sterile compounding
class 1 is just a fume hood - doesnt ensure aseptic - and will never be used (even tho meets negative pressure and vertical flow)
class 2-3 are likely to be used
class 2b2 is the best bc 0% recirculated!! any dirty air will leave the building bc 100% vented to outside
class 3 is isolators and gas-tight containers
for hazardous things, we used BSC and not laminar flow hood
what class of BSC are isolators? name the 2 types of isolators
which MUST be used for sterile preparations?
class 3
aseptic isolator and containment isolator
COMPOUNDING ASEPTIC CONTAINMENT ISOLATORS (CACIS)
aseptic gives vertical flow, but is positive in pressure, but aseptic containment also meets negative pressure requirement
**find 2 PEC’s appropriate for chemo agents
-laminar airflow workbench
-BSC class 1
-BSC class 2b2
-aseptic containment isolators
c and d
rule of thumb for cleaning
what is considered the cleanest portion>
from CLEAN to DIRTY area
start ALL THE WAY IN close to HEPA filter and TOWARDS you
the direct compounding area
what is used to clean? include the solution and the wipes used
sterile 70% IPA with lint free wipes
___ should be used to dilute disinfectant solutions used inside ISO class 5 areas
sterile water
how often to clean walls, ceiling, and storage shelfing?
MONTHYL
how often to clean floors, counters and work surfaces?
daily
how often do clean ISO class 5 and PEC’s
beginning each shift, before each batch, no more than 30 mins after starting compounding, after spills
*Where is sterile IPA used in daily cleaning
-floors and easily cleanable horizontal surfaces in the buffer area, ante rooms, and SCAs
-floors only in buffer area and ante room
-all floors, easily cleanable horizontal surfaces, and inside ISO class 5 spaces
c
*true or false
USP requires operators to use sterile water to dilute cleaning agents INSIDE of PEC
TRUE
what is the order in which the GARB should be donned???
DIRTIEST FROM CLEANEST!!!! opposite from cleaning
shoes put on 1st since they are dirtiest
true or false
before use, the surface of the laminar flow hood should be cleaned from front to back, toward the HEPA filter
FALSE
back to front, away from hepa filter
cleanest to dirtiest
true or false
you should NEVER spray onto the hood/HEPA filter
TRUE
use a spray bottle to wet the wipe instead
explain how items should be placed in the laminar flow hood
at least 6 inches into the workbench, 6 inches from each side, and 3 inches from the back (HEPA FILTER)
ALL items placed side by side to not block air flow
***when withdrawing solution from ampules into a syringe, what MUST BE USED
a filter needle!!!! (0.5 micron pore size)
this needle should then be CHANGED and replaced with regular needle before expelling the contents from the syringe
for greatest accuracy, what size syringe should be used?
should not be larger than _____ the volume ot be measured
the smallest syringe possible
no larger than 2x the volume to be measured
is it acceptable to wave over the rubber top of the ampule to make the alcohol dry faster
NO
want to withdraw 2mL solution from glass vial
how much air do we inject
BUT what about a powder vial with diluent that we have to add? want to add 5mL diluent into powder vial
2mL – same amount of air
inject 5mL of air to get diluent. THEN, inject that 5mL of diluent into the powder vial. remove 6-7mL of air so that glass vial is NEGATIVE IN PRESSURE
how should you open an ampule
quickly snap open, moving hands TOWARDS YOU AND AWAY FROM HEPA FILTER!! – DONT WANT TO PUT GLASS PARTICLES THERE
ALWAYS use filter needle and replace with regular needle to inject solution into IV bag
when injecting into IV bag, where should the IV bag openings be pointed
towards the HEPA filter
3 risk levels according to USP 797 and what this means for their BUD’s
1 - in ISO class 5 or better, that may be put in unclassified segregated compounding area have shorter BUD
2 - prepared in cleanroom suite and have longer BUD (most products)
3 - undergo sterility and endotoxin testing - more requirements than cat 2 for garbing, antisporicidal, etc. max 180 days
*product prepared aseptically in segregated compounding area and want to store at room temp
what is max BUD
less than 12 hours
(categroy 1!)
what does the media fill test test for
-did you garb and disinfect gloves properly?
-did you follow aseptic technique?
has to be CLEAR - no microbes growing
what does the gloved fingertip test, surfacen sampling test for
the ability of the person to clean and assure proper solutions and dilutions for CLEANING
USP 71***
STERILITY TEST
USP chapter 85**
bacterial endotoxin (pyrogen) testing
high risk level CSP’s made in batches of ____ or more require sterility and pyrogen testing
25 or more
**how often should the surface of the workbench be cleaned
every shift
*which PEC is NOT good for preparing hazardous products
horizontal laminar workbench
BSC class 2 b2
compoinding aseptic containment isolator (CAICS)
A
PEC is under iso….
class 5
