lecture 6 parenteral products

Question 1

aseptic technique

Answer 1

manipulation of materials in suck a way as to avoid accidental introduction of microorgansims

Question 2

aseptic technique applies to what areas

Answer 2

pharmacy
surgery

Question 3

critical aspects of aseptic techinque`

Answer 3

-proper personnel behavior
-proper handling of gloves, syringes, vials, needles, ampluls
-ensure the sterility of the final product

Question 4

what are the three sources of contamination

Answer 4

people, equipment, environment

Question 5

when did aseptic technique start

Answer 5

-formal practice started in 1972. manual revised in 1990
-USP 797 and USP 800
-it is a procedure that combines knowledge and manual skills
-either one withour the other is insufficient

Question 6

how do we take care of the sources of contamination

Answer 6

-environment: we control it
-equipment: we sterile it, we sanitize
-people: we train, we garb, we make sure they develop the habit forming skill, we periodically test them

Question 7

personal hygiene and garbing

Answer 7

-USP 797
-essential to maintain microbial control of environment
-most microbials in clean rooms are from individuals

Question 8

number of contaminations

Answer 8

-pharmacist 2 of 2057: 2 years of experience
-technician 11 of 2000: 5 years experience
-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 9

PEC

Answer 9

primary engineering control (aka laminar flow workbench)

Question 10

laminar flow

Answer 10

streamline flow of fluid in which the fluid moves in layers without turbulence. it occurs at low air velocities (~100 ft/min)

Question 11

hepa filtered

Answer 11

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

Question 12

aseptic technique: laminar flow hoods

Answer 12

-horizontal and vertical laminar flow hoods serve similar function, but are easier to work with
-comfortable aseptic technique fall in the oxymoron category (good training makes us confident)
-vertical flow must be used for hazardous drugs

Question 13

critical site of aseptic technique

Answer 13

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

Question 13

direct compounding area (DCA): aseptic technique

Answer 13

– Critical area
– Space between the HEPA filter and the critical site
– Must keep uninterrupted laminar air flow in this area, i.e., First Air

Question 14

t/f the laminar flow hood is sterile

Answer 14

laminar flow hoods are very clean but not sterile

Question 15

how do we maintain sterility in laminar flow hoods

Answer 15

-so clean that it allows us to maintain sterility through the CSP
-provided that we use proper technique
-why we call it aseptic technique and not sterile

Question 16

first air from USP 797

Answer 16

-the air exiting the hepa filter in unidirectional air stream
-compounders inderstand how to utilize the unidriectional airflow to maintain first air in DCA

Question 17

trining started (correctly) with the idea of keeping the path free for the laminar airflow _________ the critical site

Answer 17

continuously bathing

Question 18

training degenerated from _______ into ________

Answer 18

keep path clear
put the vial upside down

Question 19

what were the standard flow hood in the old days

Answer 19

horizontal flow hood