Jacobson P A, West N J, Spadoni V, Maksym C J, Pierson C
College of Pharmacy, University of Michigan, Ann Arbor 48109, USA.
Ann Pharmacother. 1996 Nov;30(11):1238-42. doi: 10.1177/106002809603001105.
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.
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.
A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room.
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.
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.
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.
确定在层流空气环境中，将非格司亭（G - CSF）从药瓶无菌转移至结核菌素注射器后，其无菌状态能否维持长达7天。
该研究分两个阶段进行：验证阶段和实验阶段。通过用常见的皮肤细菌和真菌污染物接种无菌非格司亭溶液样本对方法进行验证。样本在100级水平层流通风橱中无菌抽取到注射器中并冷藏。样本等分为若干份，分别在0小时、24小时、48小时和7天时转移至微生物培养基中；进行培养；并对微生物进行鉴定和定量。在实验阶段，非格司亭样本无菌抽取到注射器中，分为三组并冷藏。在24小时、48小时和7天时，将样本转移至肉汤中，进行培养，并观察是否出现浑浊。
一家儿科医院药房的100级层流通风橱和一个100,000级洁净室的家庭输液药房。
通过将实验肉汤培养管与对照管进行比较并观察是否出现浑浊来确定注射器中非格司亭的无菌状态。
非格司亭在定性和定量方面均显示出支持故意接种的皮肤污染物生长的能力。然而，当无菌转移至注射器并冷藏时，所有测试的非格司亭样本至少7天保持无菌状态。
在100级层流通风橱中采用无菌技术制备并冷藏保存时，非格司亭注射器可保持无菌7天。这种操作上的改变可显著节省成本。
