1. Properties of Sterile Products4
Properties of Sterile Products

2. Importance of Aseptic Preparation
Injectables bypass body’s defense: skin
Thus, IV sterile products must be free from
Particulates
Pyrogens
Other contaminants
Solutions must be clear & completely dissolved

3. Importance of Aseptic Preparation (cont’d)
No matter floating in product, such as
Rubber from coring of a vial
Precipitate from chemical reaction between ingredients

4. Particulate Matter
Any solid substance floating in an IV solution that should not be there
Rubber: stopper breaks off into vial (coring)
Glass: from opening ampule
Fibers: from opening products over uncapped needle & syringe
Undissolved drug: additive improperly dissolved

5. Particulate Matter (cont’d)
When injected into vein, particulate matter can
Lodge & block blood flow
Cause inflammation & infection
Be sure to visually inspect every product

6. pH, Acids, and Bases pH Acid:  hydrogen ions =  pH (more acidic)
A measure of acidity or alkalinity of solution
“p”: potenz, “potential to be”; “H”: hydrogen
Acid:  hydrogen ions =  pH (more acidic)
Base:  hydrogen ions =  pH (more alkaline)

7. pH Scale Range: 0 (very acidic) to 14 (very alkaline)
≤ 6.9 pH = acidic
7.0 = neutral
≥ 7.1 pH = alkaline or base
Logarithmic: decrease of 1 unit on this scale represents multiplying acidity 10 times

8. pH Scale (cont’d)
FIGURE 4-1 pH scale

9. Effect of pH on Sterile Products
pH of solution can affect how products react:
Precipitation
Heat
Gas
Cloudiness
pH of blood: 7.4 (slightly alkaline)
pH of most parenteral solutions:

10. Compatibility/Incompatibility
Drugs, when mixed, can interact, enhance, or cancel out one another
Types of incompatibility
Physical: precipitation, cloudiness, hot/cold presence, color change
Chemical: chemical reaction causes change in molecular structure or activity of ingredients
Therapeutic: giving 2 or more drugs in short period results in decreased effectiveness

11. Stability
Ability of product to remain stable until used or expiration date is reached
Factors affecting stability
Temperature
Length of time on shelf before use
Light sensitivity
Chemical reactions over time

12. Stability (cont’d) In hospital setting, average shelf life: 24-48 hrs
Long-term or home care, avg. shelf life: 30 days

13. Tonicity
Response of cells or tissues to solutions in which they are immersed
A membrane separates 2 solutions
Hypertonic: side with higher solute concentration
Hypotonic: side with lower solute concentration
Isotonic: same solute concentration on both sides

14. Tonicity (cont’d) Effects of Tonicity on Cells
Cells placed in hypertonic solution
Water moves out of cell
Cell shrivels
Cells placed in hypotonic solution
Water moves into cell
Cell swells or bursts

15. Tonicity (cont’d) Cells placed in isotonic solution No water movement
No impact on cell

16. Tonicity (cont’d)
Tonicity dictates route of administration, peripheral vs. central venous
Hypotonic & hypertonic solutions may be infused in small volumes & into large vessels
Isotonic solutions in body: milliosmoles

17. Tonicity (cont’d) A solution with tonicity out of range may cause
Tissue irritation
Pain on injection
Electrolyte shifts

18. Osmolality and Osmolarity
Definitions
Mole
Amount of substance containing ( 1023 molecules
Mass (g) of 1 mole of substance = # of atomic mass units in 1 molecule of substance
Base unit of SI system

19. Osmolality and Osmolarity (cont’d)
Definitions (cont’d)
Osmole
Amount of solute that yields # of particles that would depress freezing point of solvent by 1.86 K

20. Osmolality and Osmolarity (cont’d)
Definitions
Molality: # of moles of solute/kg of solvent
Molarity: # of moles of solute/L of solution
Osmolality: # of osmoles of solute/kg of solvent
Osmolarity: # of osmoles of solute/L of solution

21. Osmolality and Osmolarity (cont’d)
Depends on # of particles (active ions/molecules) in a solution
Commonly expressed as # of milliosmoles of solute per kg of solvent (mOsm/kg)

22. Osmolality and Osmolarity (cont’d)
Osmotic pressure exerted by a solution across a semipermeable membrane compared with H2O
Commonly expressed as # of milliosmoles of solute per L of solution (mOsm/L)