Sterile & Non-Sterile Compounding: Best Practices

Posted on Jan 25, 2025 in Chemistry

Hand-Washing Procedure

  1. Remove all jewelry. Makeup, nail polish, and false nails should not be worn.
  2. Prior to opening a scrub/brush pocket, squeeze it several times to activate the soap. Remove the scrub, sponge brush, and nail pick, and discard the packaging.
  3. Press the foot pedals to begin the flow of water. When the water is warm, wet your hands and forearms.
  4. Do not set down the sponge. Use nail picks to clean under nails. Discard the picks when finished.
  5. Scrub under the nails of each fingernail and thumbnail on the opposite hand until clean. Clean each of the four surfaces of the thumb with the sponge.
  6. In a circular motion, wash the palms and back of hands, fingers and between fingers, wrists, and lower arms. Rinse well from arms to hands. With a clean, dry paper towel or towels, pat dry, starting at the fingertips and working to the wrist. Discard the towel or towels. Repeat this step on the other hand with a clean, dry towel or towels.

Garbing Procedure

  1. Removal of personal outer garments (including all visible piercings and jewelry).
  2. Shoe covers.
  3. Head and facial hair covers.
  4. Face masks and/or eye shields.
  5. Proper hand cleansing (soap with or without antibacterial action) and drying.
  6. Non-shedding gown.
  7. Antiseptic hand cleansing (alcohol-based scrub).
  8. Sterile gloves.

IV Hood Cleaning Procedure

  1. Garb: Use the proper procedure in garbing for protection.
  2. Clear the hood: Remove everything from the hood, including anything hanging inside the hood.
  3. First: Clean the hanging bar and hooks.
  4. Second: Using overlapping strokes in a side-to-side motion, clean the ceiling of the hood using 70% isopropyl alcohol lint-free pads. Discard the used pad.
  5. Third: Using overlapping strokes in a down-and-up motion, clean the side panels using 70% isopropyl alcohol lint-free pads. Discard the used pad.
  6. Fourth: Using overlapping strokes in a side-to-side motion, clean the work surface of the hood. Discard the used pads.
  7. HEPA filter: Do not let any liquid seep into the HEPA filter, and do not touch the HEPA filter at any time. The HEPA filter is located in the back of the hood.
  8. Aseptic lint-free non-shedding hood cleaning pads: When cleaning, lightly saturate but do not drip with 70% isopropyl alcohol.

Extemporaneous Compounding

Extemporaneous compounding is the preparation, mixing, assembling, packaging, and labeling of a drug product based on a prescription order from a licensed practitioner for an individual patient. Examples include:

  • Creating an oral suspension from crushed tablets.
  • Creating a topical ointment from a drug administered by a different route.
  • Mixing two solutions for ear drops.
  • Mixing powder and cream to make an ointment.
  • Mixing powder from tablets to make an oral suspension.

Non-Sterile Compounding

Non-sterile compounding is used for:

  • Underweight children when the available dosage is too strong.
  • Patients who cannot swallow a solid form and need a liquid suspension.
  • Situations where the ordered medication is not available.
  • Ensuring that a child will take an oral medication.
  • Reducing side effects.

Used for tablets, capsules, creams, ointments, suspensions, suppositories, transdermal applications, and troches.

Compounding Records

  • Name, strength, and dosage form of the compounded sterile preparation (CSP).
  • Master Formulation Record reference for the CSP, when used.
  • Date and time of preparation of the CSP.
  • Assigned internal identification number (e.g., prescription or lot number).
  • Signature or initials of individuals involved in each step (e.g., technician or pharmacist).
  • Name, vendor or manufacturer, lot number, and expiration date of each ingredient and container-closure system.
  • Weight or measurement of each ingredient.
  • Documentation of the calculations made to determine and verify quantities and/or concentrations of components, if appropriate.
  • Documentation of quality control procedures in accordance with the Standard Operating Procedure (SOP) (e.g., filter integrity, pH, and visual inspection).
  • Any deviations from the Master Formulation Record, if used, and any problems or errors experienced during the compounding of the CSP.
  • Total quantity compounded.
  • Assigned Beyond Use Date.
  • Duplicate container label if prepared in a batch.