E2 L1 Parenteral

Question 1

Aseptic technique

Answer 1

Manipulation of materials in such a way as to avoid accidental introduction of microorganisms

Question 2

Why are pharmacy’s air standards more stringent than surgical?

Answer 2

Surgical took precautions, pharmacy did not - pharmacy MUST be cleaner than hospital

Question 3

Critical aspects of aseptic technique

Answer 3

Proper personnel behavior
Proper handling of gloves, syringes, vials, needles, ampules, etc.
Habit is crucial
Ensure the sterility of
final product

Question 4

Aseptic history

Answer 4

Started in 1973; manual revised in 1990
Practice standards:
USP <797> from 2004 and revision and USP ,<800> from 2019 and revisions
It is a procedure that combines knowledge and manual skill
One without the other is insufficient

Question 5

Aseptic technique most contaminations

Answer 5

PEOPLE
Equipment
Environment

Question 6

How we control contamination

Answer 6

Environment
-Control it
Equipment
-Sterilize
-Sanitize (take them out no longer sterile = need to sanitize)
People
Train them
Garb them
Make sure they develop habit-forming skill
Periodically test them (Tested every 6 months, AT MINIMUM every year)

Question 7

Particle shedding by people

Answer 7

Motionless: 100,000 microns/per min
Head, arm. neck leg motion - 500,000
All of above with foot motion 1,000,000

Question 8

USP <797> states squamous cells are normally shed from the human body at a rate of

Answer 8

10^6 or more per hour

Question 9

Why people with more experience make more mistakes

Answer 9

Habit forming

Question 10

Aseptic - Immediate vicinity (Critical Area) PEC

Answer 10

Primary Engineering control (aka laminar flow workbench, LAFW)

Question 11

Laminar flow

Answer 11

Streamline flow of a fluid in which the fluid moves in layers without turbulence. It occurs at low air velocities (~100ft/min) = Slow

Question 12

HEPA filtered -

Answer 12

Very clean air, ISO CLASS 5: no more than 100 particles > 0.5 micron per cubic foot (or 3,520 particles/cubic meter)

Question 13

Isolators

Answer 13

2004/2005 - hospitals had to comply to USP 797 = need for isolators
Enclosed system
Air is not in contact with the room
Air lock, only contact of the air between the two
Grab using the gloves
Not super comfortable

Question 14

Laminar flow hoods

Answer 14

Horizontal flow hoods are easier to work with
Should make you CONFIDENT not COMFORTABLE
Vertical flow must be used for hazardous (cytotoxic and vesicant) drugs
Learn vertical flow, horizontal is a walk in the park

Question 15

Critical site

Answer 15

Any point where microorganisms or other contamination could enter a parenteral product during compounding
-Pierce something = microorganisms can come in

Question 16

Direct compounding Area (DCA):

Answer 16

Critical area
Space between the HEPA filter and the critical site
MUST KEEP uninterrupted laminar air flow in this area - i.e. first air
-Air that comes straight from filter w/o any interruption and does not hit something
IF ANYTHING HITS THE AIR = NOT FIRST AIR

Question 17

Direct compounding area

Answer 17

5 inches from all sides
Items must be distanced
do not block first air

Question 18

T/F: The laminar flow hood is a sterile environment

Answer 18

False - very clean - not sterile

Question 19

Laminar flow hood sterility

Answer 19

Clean not sterile
So clean that it allows us to maintain sterility throughout the CSP
Provided that we use proper technique
This is why it is called aseptic not sterile
It is a CLEAN environment, NOT a Cleaning environment

Question 20

First Air

Answer 20

First air - the air exiting the HEPA filter in a unidirectional air airstream

Question 21

T/F: the way to empty the contents of a vial is by turning it upside down under the laminar flow hood

Answer 21

FALSE
Training started (correctly) with the idea of keeping the path free for the laminar airflow continuously bathing the critical site
Horizontal flow hoods were the norm
Training degenerated from “keep path clear” into “put the vial upside down”