Lecture 4: Sterile Liquid Formulations

Question 1

Aseptic technique

Answer 1

-proper behavior
-proper handling
-ensure sterility

Question 2

Aseptic Practice

Answer 2

-USP 797
-USP 800
-combines knowledge and manual skill

Question 3

3 sources of contamination

Answer 3

-PEOPLE (train, garb, habit form, test)
-equipment (sterilize it)
-environment (control it)

Question 4

Aseptic technique of immediate vicinity (critical area)

Answer 4

-PEC
-laminar flow
-HEPA filter

Question 5

Primary Engineering Control (PEC)

Answer 5

-laminar flow workbench
-LAFW

Question 6

Laminar flow

Answer 6

-streamline flow of fluid in which fluid moves in layers without turbulence
-occurs at low air velocities

Question 7

HEPA filtered

Answer 7

-very clean air
-ISO class 5
-no more than 100 particles per cubic foot

Question 8

Isolators

Question 9

Horizontal Laminar Flows

Answer 9

-more comfy to work with

Question 10

Vertical Laminar Flow

Answer 10

-must be used for hazardous drugs

Question 11

Critical site

Answer 11

-location that includes any component pathway surfaces ot openeings that are ecposed and at risk of contact w air, moisture, or touch contaimination
-USP 797

Question 12

Direct compounding area (DCA)

Answer 12

-critical area
-space between HEPA filter and critical site
-uniterrupted flow of first air

Question 13

first air

Answer 13

-unidirectional HEPA air

Question 14

laminar flow hood

Answer 14

-NOT sterile
-clean enough to maintain sterility

Question 15

first air examples

Answer 15

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