Sterile Compounding

Front 1

admixture

Back 1

when parental dosage forms are combined for administration as a single entity

Front 2

aseptic processing

Back 2

when product components, containers, and closures, and the product itself, are sterilized separately and then brought together and assembled in an aseptic environment. primary objective is to create a sterile product.

Front 3

controlled area (buffer area)

Back 3

the area the laminar flow workbench is in

Front 4

critical site

Back 4

any opening or surface that can provide a pathway between the sterile product and the environment

Front 5

hypertonic

Back 5

a solution that contains a higher concentration of dissolved substances than the red blood cell, which causes the red blood cell to shrink

Front 6

hypotonic

Back 6

a solution that contains a lower concentration of dissolved substances than the red blood cell, causing the red blood cell to swell and possibly burst

Front 7

isotonic

Back 7

a solution that has an osmic pressure close to that of body fluids. Minimizes patient discomfort and damage to rbc.

Front 8

sterilizing filter

Back 8

a pore size rating of 0.2 or 0.22 micron

Front 9

tonicity

Back 9

the osmotic pressure exerted by a solution from the solutes or dissolved solids present

Front 10

validation

Back 10

establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications and quality attributes

Front 11

ISO 5 area

Back 11

area has a count of no more than 3520 particles 0.5 micron or larger per cubic meter of air

Front 12

ISO 7 area

Back 12

area has a count of no more than 352,000 particles 0.5 micron or larger per cubic meter

Front 13

ISO 8 area

Back 13

area has a count of no more than 3,520,000 particles 0.5 micron or larger per cubic meter