Evaluation of an aseptic technique testing and challenge kit (ATTACK).

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)