Exam 2 Parenteral Products 4

Question 1

What is the definition of aseptic technique?

Answer 1

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

Question 2

What areas does aseptic technique apply to?

Answer 2

1. pharmacy (aka injectable products) → regulations are more strict for the cleanroom than an operating room
2. surgery

Question 3

What also needs special air care?

Answer 3

electronics! → they have to be clean or else something bad would happen to the device and it wouldn’t work

Question 4

What are the critical aspects of aseptic technique?

Answer 4

1. proper personnel behavior → attitude!
2. proper handling of gloves, syringes, vials, needles, ampules, etc
3. ensure the sterility of the final product

Question 5

How did aseptic technique develop and become in practice?

Answer 5

1. formal practice started in 1972 (not that long ago) → manual revised in 1990
2. practice standards → USP <797> from 2004 and revisions plus USP <800> from 2019 and 2022

Question 6

What is important to know about aseptic technique?

Answer 6

1. it is a procedure that combines knowledge and manual skill
2. either one without the other is insufficient
3. the hardest people to train/teach are those with an attitude or experience already (and were taught wrongly)

Question 7

What are the three sources of contamination?

Answer 7

1. PEOPLE → #1 problem is the person not following aseptic technique
2. equipment
3. environment

Question 8

How do we take care of the sources of contamination?

Answer 8

1. environment → we control it
2. equipment → we sterilize it and sanitize (disinfect) it
3. people → we train them, garb them, make sure they develop the habit forming skill, periodically test them

Question 9

What is one of the biggest things about contamination from people?

Answer 9

particle shedding! particles are shedding/being generated whenever we do anything or even nothing (aka just standing there) → the more movement you make/have, the more particles that are being generated by you

Question 10

What is the importance of attitude with aseptic technique?

Answer 10

the better the attitude, the more successful you will be → even USP <797> states that personnel should be thoroughly competent and highly motivated to perform flawless aseptic manipulations

Question 11

What is the difference between the number of contaminations made by a pharmacist and a technician?

Answer 11

pharmacist with 2 years of experience → 2 of 2057 contaminations
technician with 5 years of experience → 11 of 2000 contaminations

Question 12

Why is it more likely the technician makes more contaminations than the pharmacist?

Answer 12

technician has longer experience so they think that they’ve been doing it correctly for a longer time and actually does it wrongly

Question 13

What is the conclusion between training and knowledge of a person regarding aseptic technique?

Answer 13

the most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded

Question 14

What is important to note about the form for assessing aseptic technique by USP <797>?

Answer 14

cannot reduce the level of strictness the list has → important to not block first air!!

Question 15

What is important about the immediate vicinity (critical area) with aseptic technique?

Answer 15

1. PEC is the primary engineering control (aka laminar flow workbench LAFW)
2. laminar flow → streamline flow of a fluid in which the fluid moves in layers without turbulence, occurs at low air velocities (about 100 ft/min) → basically go with the flow!
3. HEPA filtered, very clean air, ISO Class 5 → no more than 100 particles >0.5 micron per cubic foot (or 3520 particles/cubic meter) → HEPA is a super high quality filter

Question 16

What are the different laminar flow hoods?

Answer 16

1. horizontal in which the front wall is the HEPA filter

2. vertical in which the top is the HEPA filter

Question 17

What is an isolator?

Answer 17

a chamber isolated in the room that has 2 doors in which the air inside has nothing to do with the air in the room → door is opened temporarily to put the materials in which is the only time that the air inside has contact with the air in the room

Question 18

What are some things to know about laminar flow hoods?

Answer 18

1. horizontal and vertical laminar flow hoods serve a similar function
2. horizontal flow hoods are a bit more “comfortable”
3. “comfortable aseptic technique” falls in the oxymoron category → good training should make us confident, not comfortable
4. vertical flow must be used for hazardous (cytotoxic and vesicant) products

Question 19

Which type of flow hood is easier to work in?

Answer 19

horizontal → if you can work in a vertical flow hood, you can definitely work in a horizontal flow hood (will be easier for you and you will be more confident)

Question 20

What is USP <797>’s definition of a critical site?

Answer 20

a location that includes any component or fluid pathway surfaces or openings exposed and at risk of direct contact with air, moisture, or touch contamination → risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time

Question 21

What is the USP <797>’s definition of critical area?

Answer 21

an ISO Class 5 environment

Question 22

What is our definition of a critical site?

Answer 22

any point where microorganisms or other contamination could enter a parenteral product during compounding

Question 23

What is our definition of a critical area?

Answer 23

space between the HEPA filter and the critical site → must keep first air laminar air flow in this area

Question 24

What is our definition of a direct compounding area (DCA)?

Answer 24

area within the LAFW (laminar flow workbench) where critical sites are exposed to HEPA filtered air

Question 25

With a vertical flow hood, how does the air flow?

Answer 25

up to down and then out

Question 26

Why are vertical flow hoods used with dangerous compounds?

Answer 26

if a horizontal flow hood was used, the dangerous particles would hit the person compounding in the face → if vertical flow hood is used, the particles would flow downwards

Question 27

Is the following statement true or false? "The laminar flow hood is a sterile environment."

Answer 27

MYTH

Question 28

Why is the laminar flow hood not a sterile environment?

Answer 28

1. the laminar flow hood is a very clean environment but it is not sterile → only our product is sterile 2. it is so clean that it allows us to maintain sterility throughout the CSP → provided that we use the proper technique → why the technique is called "aseptic technique" not "sterile technique" 3. it is a clean environment, not a cleaning environment → laminar flow hood only keeps the air clean, nothing else

Question 29

What is our job?

Answer 29

we want to maintain sterility to the product (not the environment)

Question 30

What does USP <797> have to say about first air?

Answer 30

1. the air exiting the HEPA filter in a unidirectional air stream that is essentially particle free 2. airflow in the PEC shall be unidirectional and because of the particle collection efficiency of the filter, the "first air" at the face of the filter is free from airborne particulate contamination 3. after proper introduction into the DCA of supply items required for and limited to the assigned operations, they are so arranged that a clear, uninterrupted path of HEPA-filtered air will bathe all critical sites at all times during the planned procedures

Question 31

The critical site should be what regarding first air?

Answer 31

the critical site should have/be exposed to first air (aka clean air) constantly!

Question 32

Is following statement true or false? "The way to empty the contents of a vial is by turning it upside down under the laminar flow hood."

Answer 32

MYTH

Question 33

Why is the following statement "The way to empty the contents of a vial is by turning it upside down under the laminar flow hood" false?

Answer 33

1. training started (correctly) with the idea of keeping the path free for the laminar airflow hitting the critical site → keeping first air is the objective! 2. horizontal flow hoods were the norm in the old days 3. training degenerated from "keep the path clear" into "put the vial upside down"

Question 34

What is our main objective with aseptic technique?

Answer 34

KEEPING THE PATH CLEAR FOR FIRST AIR

Question 35

When emptying the contents of a vial under the laminar flow hood, how should it be done to keep the path clear for first air?

Answer 35

horizontal flow hood → can hold/keep the vial up/down | vertical flow hood → vial has to be kept sideways so that downward airflow can hit the critical site