PTCB - Chapter 9 - Parenterals: Compounding Sterile Formulations - Key Concepts

Compounding Sterile Formulations
- Parenteral solutions must be sterile, free of all visible particulate material, pyrogen free, stable for their intended time of use, be isotonic, and in most cases (but not all) have a pH around 7.4

LVP Solutions
- Large volume parenteral (LVP) are 100mL or more and come in plastic bags or glass bottles

SVP Solutions
- when a drug is added to a parenteral solution, the drug is referred to as the additive, and the final mixture is referred to as the admixture

Special Solutions
- Parenteral nutrition solutions are complex admixtures composed of dextrose, fat, protein, electrolytes, vitamins, and trace elements used to meet a patient's nutritional needs

Administration Devices
- LVP solutions are usually administered with an administration set. In addition to the basic components (tubing, spikes, clamps, needle adapters), administration sets may have drip chambers, volume control chambers, and Flashballs
- Parenteral administration devices use either gravity or a pump to push the solution into the patient

Laminar Flow Hoods
- A laminar flow hood establishes and maintains an ultraclean work area for preparing parenteral solutions

Biological Safety Cabinets and Clean Rooms
- Chemotherapy agents are to be made in a biological safety cabinet, not a laminar flow hood
- Clean rooms are isolated rooms that house laminar flow hoods and biological safety cabinet; however, clean rooms that meet ISO Class 5 standards do not need a hood or cabinet

Aseptic Techniques for Hoods and Cabinets
- Aseptic techniques maintain the sterility of all sterile items and are used in preparing admixtures

Working with Vials
- There is the potential of coring the rubber stopper of a vial when inserting a needle

Working with Ampules
- Ampules may be pre-scored by the manufacturer or need to be scored with a file

Syringes and Needles
- Syringes come in sizes ranging from 1 to 60 mL
- Needle sizes are indicated by length and gauge. Large needle lumens may be needed for highly viscous solutions but are more likely to cause coring

Filters
- Syringe filters are used to remove particular materials or microorganisms from parenteral solutions

Quality Assurance and Infection Control
- A significant part of preparing parenteral solutions is to have and follow environmental quality and infection control plan
- Drugs and supplies used in making parenteral solutions should be disposed of properly. This may involve using a sharps container, or following procedures prescribed by the EPA and local landfill requirements

Parenteral Incompatibilities
- An incompatibility can exist between the drugs in an admixture or between a drug and the base IV solution

Units of Measurement
- Equivalent (Eq/L) or milliequivalent (mEq/L) concentrations are commonly used to describe concentrations of electrolytes in parenteral solutions
- Percentage concentrations refer to the drug's weight per 100 mL if the drug is a solid, or the drug's volume per 100 mL if the drug is a liquid