Evaluation of the Sterility of Single-Use Vials Undergoing Multiple Access Following Application of a Closed System Transfer Device

摘要

Background: Closed system transfer devices (CSTD) are designed for safe handling of hazardous drugs from preparation to administration. According to NIOSH, these devices are airtight and leak-proof. While these devices protect staff, as a closed system they could also minimize microbial contamination. Objective: To test whether attaching a CSTD (Equashield?) to single-use vials can minimize microbial contamination and extend the "use-by" date following multiple withdrawals under extreme-use-conditions. Methods: An Equashield? vial adapter was attached to three 20 mL vials (A, B, C) containing sterile TSB growth medium and placed in each of 6 biological safety cabinets weekly for 16 weeks. Vial A (control) had no medium removed during the week. One mL of medium was removed once daily x5 days from vial B, and twice daily x5 days from vial C. At day 5, vials were collected, incubated at 37°C for 14 days and inspected visually every 2 days for microbial growth. As a positive control, TSB vials were inoculated with less than 102 of 5. epidermidis ATC 12228. As a negative control, an unopened vial of TSB was incubated for the duration of the study. Results: All positive control vials demonstrated growth within 48 hours. All negative control vials showed no growth throughout the study. During the 16-week study all accessed vials remained sterile following storage at room temperature for 5 days and subsequent incubation for 14 days. None of the 192 vials accessed 1440 times or the 96 vials that had the CSTD attached but had no broth removed demonstrated contamination. The 95% confidence interval of the contamination rate is 0.000 to 0.035%. Conclusions: Attachment of a CSTD adapter to single-use vials within an ISO-5 environment has the ability to maintain sterility following multiple withdrawals during 5 days and stored in worse than ISO-5 conditions.