Evaluating drug stability and sterility in single-dose vials when accessed with a closed system transfer device

Area of Science:

• Pharmaceutical Science
• Microbiology
• Healthcare Management

Background:

• Drug wastage presents a significant financial burden on healthcare systems, patients, and hospital networks.
• Implementing strategies to minimize drug waste can yield substantial positive impacts across healthcare.
• Concerns regarding drug wastage necessitate investigations into practices that may prolong medication usability.

Purpose of the Study:

• To evaluate the impact of repeated access using a closed system transfer device on the sterility of single-dose vials.
• To assess the chemical stability of drugs within single-dose vials after repeated access.
• To determine if extended use of single-dose vials is feasible, thereby reducing drug wastage.

Main Methods:

• Sterility testing was conducted following United States Pharmacopeia (USP) 71 standards.
• Simulated compounding tasks using growth media and a closed system transfer device were performed in a clinical setting.
• Stability testing involved high-performance liquid chromatography (HPLC) analysis of drug samples at various time points post-access, compared to freshly opened vials.

Main Results:

• No microbial growth was detected in the accessed test vials, indicating maintained sterility.
• Control vials demonstrated microbial growth as expected, validating the testing methodology.
• Drugs within the vials maintained chemical stability for up to 72 hours post-access, comparable to freshly opened vials.

Conclusions:

• Closed system transfer devices do not introduce microbial contamination into drug vials with repeated access for up to 7 days.
• Tested drugs exhibit equivalent chemical stability for up to 72 hours after vial access.
• This study provides a framework for healthcare facilities to assess the sterility and stability of single-dose vials accessed with closed system transfer devices, supporting potential drug wastage reduction.