Compounding Manual
Education Goals & Learning Objectives

The goal of this course is to educate supervisory and technical personnel involved in the IV compounding process in both the theory and practices that assure the safety and efficacy of the IV products they compound and dispense.

I. Quality Assurance Theory for IV Admixtures

Upon completion of this section you should be able to:

• Understand the need for the application of aseptic processing in IV compounding, and define
  potential hazards to the patient associated with IV therapy.
• Understand the rationale supporting the Quality Assurance release of sterile IV admixtures,
  and describe the difference between Quality Assurance (QA) and Quality Control (QC) as they
  relate to control of variables in IV compounding programs.
• Understand and explain the role of engineering controls, barrier controls, and personnel disciplines
  in the production of unadulterated IV admixtures.
• Understand and explain the role of both the individual and the team in the production of
  acceptable-quality IV products.

2. Engineering Controls and Laminar Airflow Theory

Upon completion of this section, you should be able to perform the following tasks:

• Understand and define Primary and Secondary Engineering Controls.
• Understand and define the use of the HEPA filter.
• Understand and define the use of laminar airflow.
• Diagram the airflow patterns in a Laminar Flow Cleanbench (LFCB).
• Describe the limitations of the LFCB, and its contamination models.
• Diagram the airflow patterns in a Biological Safety Cabinet (BSC), and determine where air can be
  expected to be clean, microbiologically contaminated, and contaminated with residual drug products.
• Describe the limitations of the BSC, and list practices which defeat its protective qualities.
• Describe the design characteristics of the Buffer Zone, and its function in IV compounding procedures.
• Describe the function of anterooms or gowning areas.

3. Barrier Controls

Upon completion of this section, you should be able to:

• Describe the function of various barrier controls in aseptic processing and hazardous
  materials compounding.
• Properly use, remove, and dispose of barrier controls for aseptic processing and hazardous
  materials compounding.

4. Aseptic Manipulations

Upon completion of this section, you should be able to explain the reason for the following procedures and
perform them consistently:

• Prepare equipment and facilities, and pre-stage working materials.
• Prepare hoods for aseptic compounding.
• Stage materials for compounding in the hood correctly.
• Properly arrange materials in the work space.
• Select the appropriate compounding tools for each task.
• Evaluate risk factors, correctly perform core manipulative techniques used for various component
  packaging systems and devices, and understand the methods to be used in developing
  compounding procedures.

5. Pharmaceutical Calculations

Upon completion of this section, you:

• Understand and solve problems using ratios, performing the basic mathematical functions on both
  the numeric and unit of measure components of the equation.
• Be able to convert from one unit of measure to another, and understand what is meant by significant digits.
• Know the definition of percentage as it relates to pharmaceutical compounds and perform calculations
  using percentages.
• Calculate administration and drip rates.
• Perform dosage and dilution calculations.