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Evaluation of an aseptic technique testing and challenge kit (ATTACK)
S Turco1, W H Miele, D Barnoski
1Temple University School of Pharmacy, Philadelphia, PA.
Abstract:
Currently, there is considerable discussion and concern about quality assurance when sterile pharmaceuticals are prepared by pharmacists and other health professionals. This study describes the utility of a kit made by Marsam Pharmaceutics Inc. in detecting microbial contamination during simulated drug transfers by syringe. Common microbial detection techniques were incorporated in a simple series of transfers intended to simulate actual use. Growth promotion studies were carried out using Trypticase Soy Broth initially in tubes and then in vials (as supplied in the kit). Three test organisms were employed (Staphylococcus epidermidis, Bacillus subtilis, and Candida albicans) and inoculated at three levels, < 1000, < 100, and < 10 CFU/mL. All studies demonstrated growth occurring in 100% of the trials in 8 days. Similar studies were initiated in stored media (32 month) to determine the effects of time on the ability of the medium to support growth. Growth promoting ability of 32 month old media showed no significant difference. 100% of the vials inoculated showed growth in 8 days. Once the growth promoting qualities of the medium and vials was established a kit was developed then a study to determine the effectiveness of the kit as used was undertaken. Kits were manipulated according to the directions for use by a trained individual, under aseptic conditions and by an untrained individual in an area described as less than desirable. No growth occurred in the vials of the 10 kits used to illustrate good technique and good environmental conditions with 30% (3 of 10) of the kits showing contamination when transfers by syringe were carried out in the less than desirable setting.(ABSTRACT TRUNCATED AT 250 WORDS)
Insights
This study evaluated a kit for detecting microbial contamination in sterile pharmaceutical preparations. The kit effectively detected contamination, especially in suboptimal conditions, highlighting its utility in quality assurance.
Area of Science:
- Pharmaceutical quality assurance
- Microbial contamination detection
- Sterile pharmaceutical compounding
Background:
- Growing concerns exist regarding quality assurance in sterile pharmaceutical compounding by healthcare professionals.
- Accurate detection of microbial contamination is crucial for patient safety.
Purpose of the Study:
- To assess the utility of a specific kit in detecting microbial contamination during simulated sterile drug transfers.
- To evaluate the kit's performance under varying conditions and with aged media.
Main Methods:
- Simulated drug transfers using syringes were performed.
- Growth promotion studies utilized Trypticase Soy Broth with standard microbial test organisms (Staphylococcus epidermidis, Bacillus subtilis, Candida albicans) at varying concentrations.
- Kit performance was tested by trained and untrained individuals under aseptic and suboptimal conditions.
Main Results:
- The kit's growth media supported 100% growth of inoculated organisms within 8 days, even with 32-month-old stored media.
- Kits used with good aseptic technique showed no contamination.
- Kits used in suboptimal environments by untrained individuals demonstrated a 30% contamination rate.
Conclusions:
- The evaluated kit is effective in detecting microbial contamination during simulated sterile pharmaceutical transfers.
- The kit demonstrates reliability even with aged media and highlights the importance of aseptic technique and environmental control.