USP 797 and Aseptic Technique

Question 1

what does ISO stand for

Answer 1

international organization of sterilization

Question 2

ISO classes 5-8

which is the cleanest air quality?

Answer 2

class 5

Question 3

name what needs to be ISO class 5*

Answer 3

PRIMARY ENGINEERING CONTROL (PEC) — hood, isolator

Question 4

differentiate between what compounding areas need to be ISO class 7 vs ISO class 8

Answer 4

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

Question 5

differentiate between the divider between the ante area and buffer area between hazardous vs non hazardous compounding

Answer 5

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

Question 6

**true or false

the buffer area always needs to be ISO class 7

Answer 6

true

Question 7

what are secondary engineering controls designed to do?

Answer 7

reduce particles by delivering HEPA filtered air to the room of primary engineering control

Question 8

*true or false

if positive pressure in the buffer area, the ante area needs to be ISO class 7

Answer 8

FALSE

8

Question 9

what is the name of the area where personnel hand hygiene and garbing procedures are done?

what else must be done here?

Answer 9

ANTE AREA

supplies must be wiped down with disinfectant before being introduced into buffer area

Question 10

in which area are the primary engineering controls located

Answer 10

buffer area

Question 11

how many air changes must the buffer area have per hour?

Answer 11

at least 30

Question 12

in what area do you put on gloves - ante area or buffer area?

Answer 12

buffer area

Question 13

in what area do you put on ppe gown - ante or buffer

Answer 13

ante

Question 14

true or false

when hazardous drugs are being compounded in the buffer area, the ante room must be ISO class 7

Answer 14

true

if non hazardous can be 8

Question 15

for high risk compounding how often should air pressure differentials be reviewed and documented

how often should walls/storage be cleaned

Answer 15

at least every shift

on a monthly basis

Question 16

explain what a segregated compounding area is and what the BUD is

Answer 16

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

Question 17

true or false

for compounding hazardous preparations, clean rooms must be negative pressure

Answer 17

TRUE

if not, usually positive

Question 18

is flow from buffer to ante or ante to buffer for hazardous/nonhazardous compounding

Answer 18

for hazardous, ante to buffer
(NEGATIVE PRESSURE IN CLEAN ROOM (buffer))

for nonhazardous, buffer to ante (POSITIVE PRESSURE) . buffer area remains clean

Question 19

*place where sterile compounding personnel can garb and perform aseptic hand washing

Answer 19

ante room

Question 20

*true or false

a laminar airflow workbench is an example of a secondary engineering control

Answer 20

FALSE

primary

Question 21

*ante room serves both non hazardous and hazardous buffer area

what ISO for the ante room

Answer 21

7 since it serves both

*remember BUFFER is ALWAYS 7)

Question 22

which air flow in the laminar air flow work bench is ideal?

Answer 22

VERTICAL

air blows top down to maintain sterility and protect the worker

horizontal would blow at the worker

Question 23

most common PEC (primary engineering control) for preparing non hazardous sterile preparations

how long should it run prior to use

Answer 23

laminar airflow workbench

at least 30 mis

Question 24

biological safety cabinets are under what pressure

what are BSC’s used for?

Answer 24

negative pressure

chemotherapy and other hazardous drugs

AND VERTICAL AIR FLOW

Question 25

differentiate between class 1-3 BSC’s - biological safety cabinets

which will NEVER be used for sterile compounding

Answer 25

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

Question 26

what class of BSC are isolators? name the 2 types of isolators

which MUST be used for sterile preparations?

Answer 26

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

Question 27

**find 2 PEC’s appropriate for chemo agents

-laminar airflow workbench
-BSC class 1
-BSC class 2b2
-aseptic containment isolators

Answer 27

c and d

Question 28

rule of thumb for cleaning

what is considered the cleanest portion>

Answer 28

from CLEAN to DIRTY area

start ALL THE WAY IN close to HEPA filter and TOWARDS you

the direct compounding area

Question 29

what is used to clean? include the solution and the wipes used

Answer 29

sterile 70% IPA with lint free wipes

Question 30

___ should be used to dilute disinfectant solutions used inside ISO class 5 areas

Answer 30

sterile water

Question 31

how often to clean walls, ceiling, and storage shelfing?

Answer 31

MONTHYL

Question 32

how often to clean floors, counters and work surfaces?

Answer 32

daily

Question 33

how often do clean ISO class 5 and PEC’s

Answer 33

beginning each shift, before each batch, no more than 30 mins after starting compounding, after spills

Question 34

*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

Answer 34

c

Question 35

*true or false

USP requires operators to use sterile water to dilute cleaning agents INSIDE of PEC

Answer 35

TRUE

Question 36

what is the order in which the GARB should be donned???

Answer 36

DIRTIEST FROM CLEANEST!!!! opposite from cleaning

shoes put on 1st since they are dirtiest

Question 37

true or false

before use, the surface of the laminar flow hood should be cleaned from front to back, toward the HEPA filter

Answer 37

FALSE

back to front, away from hepa filter

cleanest to dirtiest

Question 38

true or false

you should NEVER spray onto the hood/HEPA filter

Answer 38

TRUE

use a spray bottle to wet the wipe instead

Question 39

explain how items should be placed in the laminar flow hood

Answer 39

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

Question 40

***when withdrawing solution from ampules into a syringe, what MUST BE USED

Answer 40

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

Question 41

for greatest accuracy, what size syringe should be used?

should not be larger than _____ the volume ot be measured

Answer 41

the smallest syringe possible

no larger than 2x the volume to be measured

Question 42

is it acceptable to wave over the rubber top of the ampule to make the alcohol dry faster

Answer 42

NO

Question 43

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

Answer 43

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

Question 44

how should you open an ampule

Answer 44

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

Question 45

when injecting into IV bag, where should the IV bag openings be pointed

Answer 45

towards the HEPA filter

Question 46

3 risk levels according to USP 797 and what this means for their BUD’s

Answer 46

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

Question 47

*product prepared aseptically in segregated compounding area and want to store at room temp

what is max BUD

Answer 47

less than 12 hours

(categroy 1!)

Question 48

what does the media fill test test for

Answer 48

-did you garb and disinfect gloves properly?

-did you follow aseptic technique?

has to be CLEAR - no microbes growing

Question 49

what does the gloved fingertip test, surfacen sampling test for

Answer 49

the ability of the person to clean and assure proper solutions and dilutions for CLEANING

Question 50

USP 71***

Answer 50

STERILITY TEST

Question 51

USP chapter 85**

Answer 51

bacterial endotoxin (pyrogen) testing

Question 52

high risk level CSP’s made in batches of ____ or more require sterility and pyrogen testing

Answer 52

25 or more

Question 53

**how often should the surface of the workbench be cleaned

Answer 53

every shift

Question 54

*which PEC is NOT good for preparing hazardous products

horizontal laminar workbench
BSC class 2 b2
compoinding aseptic containment isolator (CAICS)

Answer 54

A

Question 55

PEC is under iso….

Answer 55

class 5