Related Experiment Videos
Microbial viability in preparations packaged for single use.
Akiko Obayashi1, Shigeharu Oie, Akira Kamiya
1Department of Pharmacy, Yamaguchi University Hospital, Minamikogushi, Ube, Japan.
Biological & Pharmaceutical Bulletin
|May 9, 2003
Summary
Microbial growth was observed in most single-use injectable preparations. However, globulin preparations with glycine showed no microbial proliferation, allowing for residual solution use within 24 hours.
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.