Sterile Compounding Course

Lesson 1 • Introduction to Sterile Compounding

Defines sterile compounding, its clinical purpose, and patient safety implications. Provides the conceptual baseline for all technical content in this course.

Lesson 2 • Sterility Assurance Concepts

Explains sterility assurance levels, bioburden, and endotoxin fundamentals. Establishes the scientific rationale behind sterile compounding controls.

Lesson 3 • Regulatory and Quality Frameworks

Covers governing standards, accreditation bodies, and quality system requirements. Connects compliance obligations to daily compounding practice.

Lesson 1 • Airflow and Pressure Differential Design

Explains unidirectional airflow, HEPA filtration, and pressure cascade principles. Demonstrates how airflow design prevents cross-contamination between zones.

Lesson 2 • Cleanroom Classification Standards

Covers ISO classification levels, particle count limits, and their application to compounding areas. Links classification to contamination risk management.

Lesson 3 • Facility Layout and Zone Segregation

Addresses physical separation of hazardous and non-hazardous compounding areas. Reinforces how layout decisions directly affect contamination control.

Lesson 1 • Behavioral Standards Inside the Cleanroom

Defines prohibited behaviors, movement restrictions, and communication protocols within classified areas. Reinforces that personnel conduct is as critical as technical skill.

Lesson 2 • Glove Disinfection and Maintenance

Explains sterile 70% isopropyl alcohol application, contact time, and re-disinfection frequency. Maintains glove sterility throughout compounding sessions.

Lesson 3 • Hand Hygiene Principles and Technique

Covers surgical hand scrub and antiseptic hand rub procedures with correct agent selection. Establishes hand hygiene as the primary contamination control behavior.

Lesson 1 • Compounding Aseptic Isolators

Addresses isolator types, glove port integrity, and transfer port procedures for sterile compounding. Highlights advantages and limitations compared to open cleanroom environments.

Lesson 2 • Equipment Qualification and Maintenance

Covers installation, operational, and performance qualification for primary engineering controls. Ensures students understand certification cycles and out-of-specification responses.

Lesson 3 • Equipment Cleaning and Disinfection Protocols

Details cleaning agents, disinfectant rotation, contact times, and sporicidal use schedules. Maintains ISO 5 surface conditions required for sterile product integrity.

Lesson 4 • Laminar Airflow Workbench Operation

Explains horizontal and vertical LAFW design, startup procedures, and work zone boundaries. Ensures students exploit first-air protection during non-hazardous compounding.

Lesson 1 • Syringe and Needle Handling

Covers syringe selection, needle gauge choice, and safe assembly without contamination. Builds the manual dexterity foundation for all subsequent transfer techniques.

Lesson 2 • Critical Site Identification and Protection

Defines critical sites on containers and devices and explains first-air principles. Establishes the spatial awareness required for all aseptic manipulations.

Lesson 3 • IV Bag and Large-Volume Preparation

Covers additive injection into IV bags, port disinfection, and final product inspection. Integrates all prior aseptic skills into a complete preparation workflow.

Lesson 4 • Vial Reconstitution and Withdrawal

Teaches swabbing, pressure equalization, and accurate volume withdrawal from vials. Directly applies critical site and syringe skills to the most common compounding task.

Lesson 1 • Electrolyte and Osmolarity Calculations

Covers milliequivalent, millimole, and osmolarity calculations for IV electrolyte preparations. Directly supports safe parenteral nutrition and electrolyte replacement compounding.

Lesson 2 • Concentration and Dilution Calculations

Reviews percent concentration, ratio strength, and dilution equations applied to sterile products. Provides the mathematical foundation for all formulation work.

Lesson 3 • Flow Rate and Infusion Time Calculations

Covers mL/hr, drop rate, and weight-based infusion calculations for compounded IV products. Connects formulation accuracy to safe clinical administration.

Lesson 4 • Parenteral Nutrition Formulation

Addresses macronutrient calculations, caloric density, and stability requirements for TPN admixtures. Integrates calculation skills into the most complex sterile compounding scenario.

Lesson 1 • Chemical Stability Factors

Explains hydrolysis, oxidation, photodegradation, and pH effects on drug stability. Enables students to select containers, diluents, and storage conditions appropriately.

Lesson 2 • Drug Compatibility and Interaction

Addresses drug-drug and drug-container compatibility, including adsorption and leaching risks. Prevents preparation failures caused by incompatible combinations.

Lesson 3 • Physical Stability Assessment

Covers visual inspection criteria for color change, precipitation, and phase separation. Trains students to identify physical instability before product release.

Lesson 4 • Beyond-Use Date Principles

Distinguishes beyond-use dates from expiration dates and explains the regulatory basis for BUD assignment. Establishes the conceptual framework for all stability decisions.

Lesson 1 • Sterility and Endotoxin Testing

Covers sterility test methods, endotoxin limit calculations, and LAL test procedures. Validates that finished preparations meet microbiological release criteria.

Lesson 2 • Process Validation and Media Fills

Explains media fill design, frequency, incubation, and failure investigation for aseptic process validation. Confirms that personnel and processes consistently produce sterile products.

Lesson 3 • Compounding Error Classification

Categorizes compounding errors by type, severity, and root cause using established taxonomies. Provides a shared language for error analysis and prevention efforts.

Lesson 4 • Corrective and Preventive Action Systems

Addresses CAPA methodology, root cause analysis tools, and effectiveness verification. Closes the quality loop by converting error data into sustainable process improvements.