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Evaluation of two sterility testing methods for intravenous admixtures
Abstract:
The Addi-Chek Quality Control System (Millipore Corporation) and Ivex-2 Filterset (Abbott Laboratories) were evaluated to determine their effectiveness, applicability, and cost as part of a pharmacy quality-control program. Each method was tested using 50 solutions, 25 of which had been contaminated by inoculation with one of five micro-organisms; the other 25 solutions were used as controls. Aseptic technique was used, and procedures were carried out in a laminar air flow hood. Contaminated solutions were blinded from the person performing the tests. Addi-Chek detected contamination in all the inoculated solutions and in three of the uninoculated solutions. The latter may have been a result of adventitious contamination during the testing procedure. Ivex-2 detected contamination in 24 of the 25 inoculated solutions; no other contamination was found. The effectiveness of the methods in detecting low-level microbial contamination appears comparable. Both methods have been shown to be useful in the pharmacy setting, but Ivex-2 could be used to test for contamination when used as an in-line filter at the patient level. Ivex-2 is less expensive and warrants further evaluation in monitoring for microbial contamination during preparation and administration of intravenous solutions.
Insights
Two quality control systems, Addi-Chek and Ivex-2, were evaluated for detecting microbial contamination in pharmacy preparations. Both systems showed comparable effectiveness, with Ivex-2 being more cost-effective and suitable for patient-level use.
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.