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Page 1: Learning Objective 1

• Preparation for Non-Sterile Compounding

  • Necessary equipment selection

  • Cleaning of equipment and work area

  • Accurate calculation of ingredients

  • Accurate weighing or measuring of ingredients

Page 2: Process of Compounding

• Steps Involved:

  • Preparation

  • Compounding

  • Final Check

  • Analysis

Page 3: Basic Procedures for Preparation and Compounding

• Steps to Follow:

  • Review and interpret the prescription

  • Retrieve or develop a Master Formulation Record (MFR) detailing all components and procedures

  • Accurately weigh and measure all components

  • Use appropriate compounding techniques to create a finished preparation

  • Properly package and label the prescription

  • Document preparation using a Compounding Record (CR)

Page 4: Prescription Requirements

• Key Elements:

  • Patient Information: Name, Address, Date of Birth

  • Prescriber Information: Name, Address, Professional Designation, ID Number (NPI or DEA)

  • Prescription Details:

    • Date written

    • Medication: Name, Strength, Dosage Form

    • Directions for Use

    • Quantity Dispensed

    • Number of refills

Page 5: Measuring Solids

• Equipment Options:

  • Class III Prescription (Torsion) Balance:

    • Labor intensive and uses weight sets

    • Sensitivity Requirement: 6 mg

    • Min Weighable Quantity: 120 mg

    • Max Weighable Quantity: 60-120 grams

  • Electronic Balance:

    • Easier to use

    • Sensitivity Requirement: as little as 1 mg

    • Max Weighable Quantity: Up to 600 grams

  • Weight Sets:

    • Weigh boats or weighing papers

Page 6: Measuring Solid Ingredients

• Importance of Accuracy:

  • Calculate and measure the quantity of each ingredient accurately

  • Metric system primarily used, occasional use of the apothecary system (e.g., fl oz, pint, quart, gallon)

  • Acceptable error: 5% generally, less for high potency/toxicity drugs

  • Percent error equation: % = (error/actual) x 100%

Page 7: Measuring Liquids

• Precision Volumetric Glassware:

  • Features capacity inscribed and calibrated

  • Types include:

    • Cylindrical and Conical Graduates

    • Syringes

    • Volumetric Flasks

    • Calibrated Pipettes

Page 8: Selecting Appropriate Liquid Measuring Device

• Device Selection Considerations:

  • Use the smallest appropriate device to minimize error

  • Cannot measure below 20% of capacity

    • Example: For a 50 ml graduated cylinder, cannot measure <10 ml

  • For volumes <1 ml, prefer graduated pipet, syringe, or calibrated dropper

  • Disposable syringes recommended for oily and viscous liquids

  • Avoid using prescription bottles, non-volumetric flasks, beakers, or household teaspoons for measurements

Page 9: Learning Objective 2

• Preparation for Sterile Compounding:

  • Handwashing and garbing

  • Cleaning the IV hood

  • Accurate calculation and measuring of ingredients

Page 10: Equipment for Sterile Compounding

• Laminar Airflow Workbench:

  • Non-hazardous

  • Two airflow types:

    • Horizontal: Back to front

    • Vertical: Top to bottom

Page 11: Cleaning and Disinfecting Hood

• Cleaning Protocol:

  • Clean and disinfect at:

    • Beginning of each shift

    • Before each batch

    • Every 30 minutes during compounding

    • When visibly soiled or suspected contamination

    • If hood is turned off, run for 30 minutes before cleaning with sterile water and 70% isopropyl alcohol

Page 12: Cleaning Laminar Airflow Workbench

• Cleaning Steps:

  • Remove visible solids using sterile water

  • Disinfect using 70% isopropyl alcohol

  • Clean:

    • Pole and Hooks

    • Sides top to bottom, back to front

    • Work surface side to side, back to front

Page 13: Preparing Sterile Product

• Gather Materials:

  • Include: syringe, bag, needle, alcohol swab, etc.

  • Work within recommended distance from air source

  • Keep only necessary equipment inside hood for sterile compounding

Page 14: Aseptic Technique

• Preparation Protocols:

  • Disinfect vials, ampules, and injection ports using an alcohol wipe

  • Prepare syringe by removing plastic overwrap

  • Prepare needle by removing plastic overwrap

Page 15: Aseptic Technique Essentials

• Critical Areas:

  • Identify "critical sites" where contamination might enter

    • Syringe tips, plunger, needle tips, rubber stopper of vial

    • Ensure clean air ("first air") is unobstructed from hood to critical sites

    • Do not place items on the hood surface to maintain sterility

Page 16: Withdrawing from a Vial

• Withdrawal Techniques:

  • Enter vial with syringe and needle:

    • Ensure bevel of needle faces up

    • Needle at a 45-degree angle to stopper

  • Withdrawal protocol:

    • Add ~ half the volume of air to the vial as the volume to be withdrawn

    • Utilize milking technique to prevent overspray from increased pressure in vial

Page 17: Aseptic Technique for Injection

• Injection Method:

  • Ensure the additive port remains in contact with first air

  • Preferred placement: vertical bag on IV bar

  • Horizontal bag placement on alcohol wipe

  • Position additive port closest to the HEPA filter

Page 18: Final Steps in Aseptic Technique

• Inspection Protocol:

  • Inspect admixture for particulate matter and incompatibilities

  • Confirm that final container is intact and sterile.