Sterile Compounding - Answers parenteral solutions must be sterile, free of all visible particulate
material, pyrogen-free, and stable for their intended time of use. In most cases they will also be
isotonic and have a pH around 7.4
Regulations - Answers standards for sterile compounding are developed by the USP-NF. The
FDA and state boards of pharmacy have jurisdiction over the enforcement of the standards.
USP Chapter <797> Pharmaceutical Compounding--Sterile Compounding is the primary sterile
compounding.
LVP Solutions - Answers Large volume parenterals (LVP) are 100ml or more and come in plastic
bags or glass bottles. Drugs can absorb to the plastic in some types of bags, and some plastic
bags allow plasticizers to be leached into the parenteral solutions.
SVP Solutions - Answers 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 - Answers Parenteral nutrition solutions are complex admixtures composed of
dextrose, fat, proteins, electrolytes, vitamins, and trace elements used to meet a patient's
nutritional needs.
Administration Devices - Answers -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.
Primary Engineering Controls (PECs) - Answers sterile preparations must be made in
environments with a controlled number of airborne particles. ISO limits for sterile compounding
are Class 5, 7, and 8. Appropriate environments must be maintained by PECs such as laminar
airflow workstations, biological safety cabinets, isolators, and clean rooms.
Aseptic Techniques for Compoundings CSPs - Answers -Aseptic techniques are the sum total of
methods and manipulations required to minimize the contamination of a CSP
-Garbing is the special clothing worn to reduce contamination from the compounder in or
around the PEC
-Some PECs require special cleaning procedures just prior to compounding a CSP.
-Correct placement of compounding materials in PECs is critical
-When working inside a PEC device (laminar airflow workstation) the technician must know:
, when to turn the PEC on/off; the order in which the various parts inside of the PEC should be
cleaned; and how to work in a device with a zone of turbulance
Aseptic Techniques for Working with Vials - Answers there is the potential of coring the rubber
stopper of a vial when inserting a needle.
Aseptic Techniques for Working with Ampules - Answers ampules may be prescored by the
manufacturer or need to be scored with a file.
Syringes & Needles - Answers -Syringes come in sizes ranging from 1 to 60ml
-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.
Needle-Free Devices - Answers Needle-free systems are used to administer preparations or
transfer ingredients during the compounding of CSPs to reduce the possibility of sharps related
injuries.
Filters - Answers syringe filters are used to remove particulate materials or microorganisms
from parenteral solutions
Final Check and Waste Disposal - Answers -A compounded CSP must be checked for closure
integrity, particulate material, and unexpected color, fill volume, precipitation, or inconsistency
-The label must be verified with the prescription order
-The disposal of all compounding materials regulated by the EPA and local instituion SOPs
should be followed
Infection Control - Answers A robust infection control program should be documented in local
institution's SOPs and followed by compounding technicians. The program will consist of
cleaning, washing, disinfecting, and testing procedures.
Quality Assurance - Answers A quality assurance program is a series of steps intended to
monitor, evaluate, correct, and improve assurance that a CSP will be safe, stable, and of the
proper identity, strength, purity, and quality.
Parenteral Incompatibilities - Answers An incompatilibilty can exist between the drugs in an
admixture solution or between a drug and the base IV solution
Units Of Measurement - Answers -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 100ml if the drug is a solid, or the
drug's volume per 100ml if the drug is a liquid
additive - Answers a drug that is added to a parenteral solution