Sterility of filgrastim (G-CSF) in syringes.
OBJECTIVE
To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment.


METHODS
The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0, 24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity.


METHODS
A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room.


METHODS
The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity.


RESULTS
Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days.


CONCLUSIONS
Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.
College of Pharmacy, University of Michigan, Ann Arbor 48109, USA.
P A
PA
Jacobson
N J
NJ
West
V
V
Spadoni
C J
CJ
Maksym
C
C
Pierson
D004340:Drug Contamination; D004355:Drug Stability; D004780:Environment, Controlled; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000737:chemistry* / Q000191:economics / Q000494:pharmacology; D006801:Humans; D008826:Microbial Sensitivity Tests; D011994:Recombinant Proteins; D013242:Sterilization / Q000379:methods*; D013594:Syringes; D013997:Time Factors
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim