Properties of Sterile Products 4 Properties of Sterile Products

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

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

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

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

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)

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

pH Scale (cont’d) FIGURE 4-1 pH scale

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: 3.5-6.2

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

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

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

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

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

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

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: 280-310 milliosmoles

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

Osmolality and Osmolarity Definitions Mole Amount of substance containing 6.022 ( 1023 molecules Mass (g) of 1 mole of substance = # of atomic mass units in 1 molecule of substance Base unit of SI system

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

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

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)

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)