Microbial viability in preparations packaged for single use

Area of Science:

• Microbiology
• Pharmaceutical Science
• Clinical Pharmacy

Background:

• Single-use injectable preparations often carry warnings to discard residual solutions due to potential microbial contamination.
• Commonly used preparations include albumin, globulin, fat emulsions, and their derivatives like urokinase, interferon, and propofol.

Purpose of the Study:

• To evaluate the microbial viability in various single-use injectable preparations.
• To determine if residual solutions of specific preparations can be safely used within a defined period.

Main Methods:

• Inoculation of preparations with Serratia marcescens and Burkholderia cepacia.
• Incubation at 30°C for 24 hours to assess microbial proliferation.
• Comparison of growth in standard preparations versus globulin preparations containing glycine.

Main Results:

• Serratia marcescens and Burkholderia cepacia proliferated rapidly in most tested preparations at 30°C.
• No microbial growth was detected in globulin preparations containing 1-2.25% glycine over 24 hours at 30°C.
• Specific globulin products tested included Gamma-Venin P, Venilon-I, Globulin Injection, and Ahlbulin.

Conclusions:

• Globulin preparations containing 1-2.25% glycine exhibit antimicrobial properties preventing rapid microbial growth.
• The recommendation to discard residual solutions in these specific globulin preparations may be revised.
• Residual solutions of glycine-containing globulin preparations can potentially be used within 24 hours if stored properly.