Evaluation of two sterility testing methods for intravenous admixtures

Area of Science:

• Pharmaceutical quality control
• Microbiology
• Healthcare technology assessment

Background:

• Pharmacy quality control is essential for patient safety.
• Reliable methods are needed to detect microbial contamination in pharmaceutical preparations.
• Existing quality control systems require evaluation for effectiveness and cost-efficiency.

Purpose of the Study:

• To evaluate the effectiveness, applicability, and cost of the Addi-Chek Quality Control System and Ivex-2 Filterset.
• To compare the performance of these two systems in detecting microbial contamination in pharmaceutical solutions.
• To determine the suitability of these systems for pharmacy quality-control programs.

Main Methods:

• Two quality control systems, Addi-Chek and Ivex-2, were assessed.
• Fifty solutions were tested: 25 inoculated with microorganisms and 25 controls.
• Aseptic techniques were employed within a laminar air flow hood, with blinded testing for contamination.

Main Results:

• Addi-Chek detected contamination in all inoculated and three uninoculated solutions.
• Ivex-2 detected contamination in 24 of 25 inoculated solutions, with no false positives.
• Both methods demonstrated comparable effectiveness in identifying low-level microbial contamination.

Conclusions:

• Both Addi-Chek and Ivex-2 are valuable tools for pharmacy quality control.
• Ivex-2 offers a cost-effective alternative and potential for in-line, patient-level contamination testing.
• Further evaluation of Ivex-2 for monitoring intravenous solution preparation and administration is warranted.