Evaluating Sterility of Single Dose Vials on an Automated Compounding Device

Area of Science:

• Pharmaceutical Compounding
• Sterility Assurance
• Cleanroom Technology

Background:

• Current sterile compounding guidelines mandate discarding single dose vials after 6 hours when accessed in an ISO Class 5 environment.
• No prior studies have assessed the sterility of single dose vials post-access over extended periods.
• This research addresses a critical gap in understanding vial sterility beyond the established 6-hour limit.

Purpose of the Study:

• To evaluate the sterility of single dose vials connected to an automated compounding device for up to 24 hours.
• To assess vial sterility within a controlled cleanroom environment (ISO Class 5).
• To provide data that may inform revisions to beyond-use dating guidelines.

Main Methods:

• Prospective, observational study involving 32 pooled samples of injectable drugs.
• Vials were attached to an automated compounding device within an ISO Class 5 environment for up to 24 hours.
• Sterility testing was performed using membrane filtration incubated for 14 days, adhering to USP <71> standards.

Main Results:

• All 32 pooled samples demonstrated successful sterility after up to 24 hours.
• Vials were attached to the compounder for an average of 23.8 hours.
• An average of 20.4 manipulations occurred per vial during compounding.

Conclusions:

• Single dose injectable drugs processed with automated compounding devices in ISO Class 5 environments can maintain sterility for up to 24 hours.
• Findings suggest current 6-hour discard policy may be overly conservative.
• Further research with larger sample sizes and dynamic conditions is recommended to support extended beyond-use dating under USP <797>.