Sterile solution dosage forms Flashcards
Exam 2 Content (Pinal's Lectures)
Aseptic Technique
Manipulation of materials in such a way as to avoid accidental introduction of microorganisms
What areas is aseptic technique used?
Surgical and Pharmacy (pharmacy is more stringent)
USP 797
used for ALL injectables
USP 800
used for HAZARDOUS drugs, if they are injectable then they also fall under USP 797
Three sources of aseptic technique contamination
-people (main source)
-equipment
-environment
How do we take care of contaminations?
-environment: control it (set standards for first air)
-equipment: sterilize it and sanitize it (disinfection)
-people: train, garb, develop good habits, test them (once a year min.)
Training and Knowledge
More experience doesn’t mean that you’re doing it right
PEC
primary engineering control/laminar flow LAFW
Laminar flow
streamline flow of a fluid in which the fluid moves in layers without turbulence
HEPA filtered
VERY CLEAN (ISO Class 5)
-has <100 particles per 0.5 microns per cubic foot
Horizontal flow
-type of laminar flow hood
-air is blowing on your face
-easier to make someone confident
Vertical flow
-type of laminar flow hood
-air is coming from ABOVE the hood
-used for HAZARDOUS drugs (so it doesn’t blow back in your face)
Isolators
closed system, nothing is exposed to the outside environment
Critical site
-a point where microorganisms are other contamination could enter a parenteral product
-ex: hole when piercing a rubber stopper
Direct compounding area
-critical area
-space between the HEPA filter and the critical site
-must keep uninterrupted laminar air flow in this area (First air)
Is the laminar flow hood a sterile environment?
No, it is VERY CLEAN but not sterile
First air
the air exiting the HEPA filter in a unidirectional air stream
OsmolaLity
the concentration of particles dissolved in solution (osmoles of solute per kg of solvent)
OsmolaRity
-number of osmoles of a solute in a LITER of solvent
-whether they dissociate
-measured by an osmometer
Osmosis
-diffusion of water
-water flows from HIGH concentration (of water) to LOW concentration (of water) to DILUTE the more solute concentrated side
-semipermeable membrane
Iso-osmotic
-maintaining and possessing a uniform tension or tone of the cellular membrane of the cell
-same m-particles and concentration of the BLOOD SERUM
Isotonic
cells will stay alive
-is something is isotonic, then the cell will be able to tolerate that concentration
What are the two ways that concentration equalizes?
Diffusion and Osmosis
Diffusion
-SOLUTE moves from HIGH to LOW
-permeable membrane
What kind of membrane do cell membranes have?
semipermeable (some things can cross, others can’t)
Impermeable
nothing goes through (cell starves)
Permeable
everything goes through (cell ends as an empty shell and dies)
Do cells want to fold or expand?
FOLD, if a HYPOtonic vehicle is administered then it can burst the cell
How do you measure the osmolarity and osmolality of a preparation?
Osmometer through the use of colligative properties