Sterile Compounding

An overview of SDVs and MDVs in sterile compounding practices

Single-Dose Vials (SDVs)

Single-dose vials are designed for the administration of a single injection or dose medication. They are typically used to minimize contamination risks and are intended for immediate use after opening. Once accessed, SDV contents must be utilized promptly, ensuring that there is no opportunity for multiple uses. Their use is crucial in sterile compounding environments uphold safety standards.

Multi-Dose Vials (MDVS)

Multi-dose vials contain multiple doses of medication that can be accessed multiple times over a designated period. They must contain preservatives to prevent bacterial growth, given that they will be accessed repeatedly. MDVs are convenient for medication storage and preparation, but they require strict adherence to aseptic techniques to prevent contamination during withdrawal. Training in proper handling is essential for any personnel who will use MDVs in sterile compounding.

Safety and Best Practices

To ensure safety in sterile compounding, it is crucial to follow strict guidelines when using vials. This includes ensuring that the work environment is sterile, using appropriate personal protective equipment (PPE), and employing aseptic technique during handling. Regular training and audits help maintain compliance with safety regulations to prevent contamination and ensure the integrity if compounded sterile products.

Vial Handling Techniques

Withdrawing Fluid from Vials

Withdrawing fluid from vials requires precise technique to prevent contamination. Begin by disinfecting the rubber stopper of the vial with an appropriate aseptic wipe. Use a sterile syringe needle long enough to reach the bottom of the vial. Insert the needle through the stopper while maintaining a steady pressure to draw the desired volume of fluid, ensuring the needles does not touch any non-sterile surfaces.

Reconstituting Powdered Medications

Reconstitution of powdered medications involves mixing the powder with a sterile diluent to prepare it for use. First, ensure that both the power vial and diluent are at room temperature. After disinfecting the stoppers, draw the correct volume diluent into a syringe. Inject the diluent into the powder vial, then gently swirl to ensure complete dissolution. Avoid shaking vigorously to orevent foaming or degradation of the medication.

Inserting Contents into Compounded Products

When transferring the reconstituted medication into compounded products, follow aseptic techniques rigorously. Use sterile syringes and transfer devices, ensuring the work surface is clean and the environment is controlled. After drawing the dose into a syringe, slowly inject it into the compounded product’s designated area while avoiding direct contact with non-sterile surfaces. Label the compounded product accurately and store it under appropriate conditions.

Introduction

• Small-volume parenteral preparations

  • Sterile solutions of 250 mL or less that are administered parenterally

• Intravenous piggyback

  • Intermittent infusions containing a standard base solution and an IV medication

  • The most common type of SVP made in the cleanroom

  • Given or piggybacked through a main IV line

• Common IVPB base solutions

  • 0;/9% sodium chloride (normal saline, NS)

  • Dextrose 5% in water

  • 0.45% sodium chloride (1/2 NS)

• Common IVPB volumes

  • 50 mL

  • 100 mL

• Diluent used to reconstitute sterile powdered drugs

  • Sterile water

  • 0.9% sodium chloride

• Bacteriostatic diluents

  • Diluents with preservatives

  • Bacterial growth inhibited in the diluent vial

  • Preservatives used include methylparaben and benzyl alcohol

• Preservative-free diluents

  • Diluents without preservatives

• Situations in which preservative-free diluents used

  • Neonatal patients

  • Intrathecal administration

  • Upon physician request