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Effective: Summer 2013

Prerequisites: Prerequisite: PHT 52A.
Grade Type: Letter Grade Only
Not Repeatable.
FHGE: Non-GE Transferable: CSU
3 hours lecture, 3 hours laboratory. (72 hours total per quarter)

Student Learning Outcomes -
  • Describe the main components of the infection cycle and factors affecting survival of bacteria and utilize various methods of preventing the spread of micro-organisms and contaminants.
  • introduction to aseptic compounding principles,techniques,precautions, and regulations governing preparation of sterile compounds
Description -
Compounding of sterile products according to the appropriate technique. An introduction to the concepts of sterility and incompatibility. The use of applicable quality assurance processes and performance of work in accordance with the laws, regulations, and standards which govern the preparation of sterile products, with special emphasis on the preparation of parenteral chemotherapy with strict adherence to all precautionary standards. Intended for students in the Pharmacy Technician Program; enrollment is limited to students accepted in the program.

Course Objectives -
The student will be able to:
  1. describe the main components of the infection cycle and factors affecting survival of bacteria.
  2. identify and utilize methods of preventing the spread of microorganisms as in aseptic technique.
  3. describe and demonstrate the aseptic handling of equipment and supplies used in the preparation of sterile pharmaceuticals. (including laminar airflow hoods).
  4. utilize various documentation in assuring quality assurance including process validation and various types of validation testing.
  5. apply the concept of risk levels.
  6. describe the characteristics, stability, incompatibilities, and patient complications of sterile compounded parenterals.
  7. identify common pharmaceuticals that are administered parenterally and describe their uses.
  8. identify common chemotherapy agents, their uses, and special handling requirements
Special Facilities and/or Equipment -
Laboratory supplied with water and electricity, Laminar Flow Hood, materials necessary for aseptic preparation of parenteral products and hazardous substances, admixture pump, hazardous substances/sharps disposal equipment, hazardous substances spill kit, labels. Textbooks, overhead, video tapes, multimedia cart, and charts.

Course Content (Body of knowledge) -
  1. Infection (L-L)
    1. Definition
    2. Types of microorganism
    3. Cycle of infection
    4. Mode of transmission
    5. Transmission of various diseases
    6. Bacteria survival factors
    7. Methods of preventing infection
  2. Aseptic technique (L-L)
    1. Aseptic hand washing
    2. "sterile" vs. "non-sterile" in a pharmacy
    3. manipulations in the LFH to assure sterility in products
    4. preparations using ampoules, vials, and syringes
    5. labeling and packaging sterile products
    6. specialized storage for sterile products
  3. Aseptic handling and use of equipment (L-L)
    1. handling supplies/equipment used in the aseptic preparation of pharmaceuticals
    2. laminar air flow hoods(horizontal and vertical flow) - use, maintenance and
  4. Quality control (L-L)
    1. In-process tests and inspections of personnel performance, equipment, facilities and product.
    2. Recalls
    3. Risk levels and considerations
    4. Documentation
    5. Batch record requirements
  5. Understanding Risk Levels for Compounded Sterile Products (Lec)
    1. Immediate Use CSP Risk Level
    2. Low Risk Level CSP with 12 hour or less BUD
    3. Low Risk Level CSP
    4. Medium Risk Level CSP
    5. High Risk Level CSP
  6. Compounding sterile products (L-L)
    1. Products commonly used in parenteral preparations
    2. Characteristics of sterile products
    3. Particulate matter and prevention of particulate matter
    4. Pyrogens
    5. Incompatibilities affecting sterile products
    6. Stability and other factors affecting sterile products
    7. Patient complications related to compounding of sterile products
  7. Parenteral routes of administration (L-L)
    1. Sterile parenteral nutrition solutions
      1. Patient nutritional requirements
      2. Additives
      3. Incompatibilities of additives
      4. Labeling and storage
    2. Large volume Parenterals
    3. Small Volume Parenterals (IVPB)
    4. Patient Controlled Analgesia (PCA)
    5. Enterals
  8. Hazardous drug preparation (Lec)
    1. Examples
    2. Chemotherapy agents and uses
    3. Chemotherapy terminology
    4. Procedures for handling sterile injecteble hazardous drugs to include protective apparel, labeling, transportation, and storage.
    5. Hazardous drug spills
Methods of Evaluation -
The following evaluation methods may be used but are not limited to:
  1. Objective exams
  2. Lab Practical Exams
  3. Quizzes
  4. Laboratory Notebook
Representative Text(s) -
American Pharmacists Association, Perspective Press. The Pharmacy Technician. Fourth Edition. Englewood:Morton Publishing Company, 2010.
Acosta, Renee. Sterile Products for Pharmacy Technicians. First Edition. Baltimore, MD:Lippincott Williams & Wilkins, 2010.
Hitner, Henry & Nagle, Barbara. Pharmacology: An Introduction. 6th ed. Boston, MA: McGraw Hill, 2012.

Disciplines -
Pharmacy Technology
Method of Instruction -
  1. Lecture presentations and classroom discussion regarding topics.
  2. Small group recitation sessions to discuss concepts.

Lab Content -
  1. Aseptic technique and hand washing and hood cleaning
  2. Barrier controls and equipment for sterile production
  3. IVPB production, labeling & documentation
  4. Ampule manipulation and transfer from ampule
  5. Reconstitution production, labeling & documentation
  6. Adult parenteral nutrition preparation and documentation
  7. Chemotherapy Theory and demonstration

Types and/or Examples of Required Reading, Writing and Outside of Class Assignments -
  1. Weekly summary of clinical experiences
  2. Self-evaluation of experiential competency.