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Sterility of filgrastim (G-CSF) in syringes
P A Jacobson1, N J West, V Spadoni
1College of Pharmacy, University of Michigan, Ann Arbor 48109, USA.
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.
Design:
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.
Setting:
A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room.
Main Outcome Measures:
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.
Insights
Filgrastim (G-CSF) in syringes remains sterile for 7 days when prepared aseptically in a laminar airflow hood and refrigerated. This finding supports safe, cost-effective preparation of G-CSF for patient use.
Area of Science:
- Pharmaceutical Science
- Microbiology
- Healthcare Management
Background:
- Granulocyte-colony stimulating factor (G-CSF) is crucial for managing neutropenia.
- Aseptic technique is vital for maintaining the sterility of injectable medications.
- The stability of G-CSF in pre-filled syringes impacts clinical practice and cost.
Purpose of the Study:
- To assess the sterility of filgrastim (G-CSF) after aseptic transfer to tuberculin syringes.
- To determine if sterility is maintained for up to 7 days under refrigeration.
- To evaluate the potential for cost savings through optimized G-CSF preparation.
Main Methods:
- Aseptic transfer of filgrastim from vials to tuberculin syringes within a class 100 laminar airflow hood.
- Validation phase: Inoculation of filgrastim with common contaminants, followed by incubation at specified time points (0, 24 hours, 7 days).
- Experimental phase: Aseptic preparation and refrigeration of filgrastim in syringes, with subsequent broth culture to assess sterility.
Main Results:
- Filgrastim solution supported the growth of inoculated skin contaminants in validation tests.
- All aseptically prepared and refrigerated filgrastim samples in syringes remained sterile for at least 7 days.
- No turbidity indicating microbial growth was observed in experimental samples.
Conclusions:
- Aseptic preparation of filgrastim in syringes within a laminar airflow hood ensures sterility for up to 7 days when refrigerated.
- This validated method allows for extended storage of prepared syringes.
- Implementation can lead to significant cost reductions in healthcare settings.