. 2019 May 15;28(2):65–70. doi: 10.1136/ejhpharm-2019-001913

Table 2.

Microbial contamination of vials used for preparation with closed-system drug transfer device compared with a conventional system

References	Manipulations	Culture and detection techniques	Incubation times	Global contamination	Comments
Whitehead et al ²⁷	According to USP <797> in ISO5 cleanroom + 1 CSTD (brand not specified) and 2 conventional systems (1 NCDP spike and 1 syringe) 22 vials of alfaxalone without preservative.	Incubation of tubes at 36°C 18–24 hours. Macroscopic evaluation and subsequent blood agar plates.	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 days.	6/22 (27%) tubes (1 CSTD, 1 NCDP and 4 syringes).	CSTD unspecified. Conflict of interest: Jurox Pty Ltd.
Garrigue et al ²⁹	Outside the isolator in an ISO7 cleanroom + classical spike and 2 CSTD (PhaSeal, Viashield/Texium). 3 media-fill tests of TSB.	Incubation at 30–35° 14 days. Macroscopic evaluation.	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 days.	0/30 PhaSeal. 0/30 Viashield/Texium. 0/30 Classical spike.	Conflict of interest: CSTDs provided by Becton Dickinson and CareFusion.
Savry et al ²⁸	Outside the isolator in an ISO7 cleanroom + classical spike and 2 CSTD (PhaSeal and Spiros/Genie). 3 media-fill tests of TSB.	Incubation at 30–35° 14 days. Macroscopic evaluation.	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 days.	0/30 conventional. 0/30 PhaSeal. 1/40 (2.5%) Spiros/Genie.	Conflict of interest: none.

CSTD, closed-system drug transfer device; ISO5, International Organization for Standardization 5; NCDP, non-closed dispensing pin; TSB, tryptic soy broth; USP, US Pharmacopeia.