単回使用バイアルの分割使用を前提とした保管条件の違いによるバイアル内無菌性保持の検討

抄録

When microbes present on the rubber stopper in a vial or attachment part of closed system drug transfer devices (CSTD), these microbes may contaminate vials by needle puncture.

We examined the preservation of sterility in vials by different vial storage conditions on the premise of divided use of single-use vials.

Experiments were conducted using liquid medium filled vials under the following conditions A-D. [A: Removed rubber stoppers (open-vials) and placed in safety cabinet (BSC), B: Placed open-vials in preparation room (ISO class 8), C: Placed negative-pressured vials with rubber stopper punctured twice by needle in preparation room, D: Placed the vials connected to CSTD in preparation room.]

After 24 hours and 7 days, portions of the culture medium in the vial were cultured.

In conditions A, C and D, no growth of microbes was confirmed except in B.

Microbial contamination didn't occur when vials were stored in BSC.

When the vials were stored under the ISO Class 8 environment, it is suggested that microbes may adhere to the rubber stopper of the vial. Even if the inside of the vial after puncture was negative pressure, the rubber stopper showed a certain protective effect from microorganism adherence, and CSTD was similar.

Therefore, the vial storage condition in BSC (ISO class 5) is considered preferable on the premise that a single use vial is divided. However, if the rubber stopper or CSTD is connected even in an ISO class 8 environment, the sterility is retained for 7 days.