背景:注射器通常用于制药复合中,用于测量小体积,特别是在注射和输液用无菌产品的制备中。然而,目前尚无正确使用注射器测量小体积的官方指南。目的:该项目的目的是确定市售注射器在无菌产品制备过程中测量小体积的准确性和精密度,以对注射器尺寸选择提出建议。方法:评估注射器的精确度和准确性,3名独立调查人员测量了5%,10%,或1-体积的20%(每个n=30),3-,5-,10-,或配有18G的20毫升注射器,1½“针头,从小瓶中抽出无菌注射用水。使用电子天平重量分析测量递送的体积,并使用水的比重(1.0)转换成体积。准确度表示为平均值和标准偏差,而精度表示为相对标准偏差百分比。使用单因素方差分析评估差异,Bonferroni调整和显著性设置为P<0.05。结果:与研究者内部和研究者之间的理论体积相比,精确度和准确性差异很大,并且通常存在显着差异(P<.05)。当测量到小于20%的注射器的标记容量时,观察到不可接受错误(>5%)的可能性增加。平均百分比误差范围从1.4%到18.6%,尽管制造商规范的精度为±5%,建议将适当的技术作为小体积测量的主要因素。结论:除了适当的,经过验证的注射器用户培训,我们建议用户在选择尽可能接近所需测量值的注射器时,测量注射器不低于指定体积的20%。如果可能,应稀释非常小的体积以满足可用的最小注射器的最小体积。这些建议的实施将提高准确的剂量,最终,患者安全。
Background: Syringes are commonly used in pharmacy compounding for the measurement of small volumes, especially in the preparation of sterile products for injection and infusion. However, there are no current official
guidelines for the proper use of syringes in measuring small volumes. Objective: The purpose of this project was to determine the accuracy and precision of commercially available syringes in measuring small volumes during sterile product preparation to make recommendations for
syringe size selection. Methods: To assess precision and accuracy of syringes, 3 separate investigators measured 5%, 10%, or 20% (n = 30 each) of the volume of a 1-, 3-, 5-, 10-, or 20-mL syringe with an attached 18G, 1½\" needle by drawing sterile water for injection from a vial. Delivered volumes were measured gravimetrically using an electronic balance and converted to volume using the specific gravity of water (1.0). Accuracy is represented as the mean and standard deviation, while precision is represented as percent relative standard deviation. Differences were assessed using a 1-way analysis of variance with Bonferroni adjustments and significance set at P < .05. Results: Precision and accuracy were highly variable and often significantly (P < .05) different compared to the theoretical volume delivered both within and between investigators. An increased likelihood of unacceptable error (>5%) was observed when less than 20% of the labeled capacity of a syringe was measured. Mean percent error ranged from 1.4% to 18.6%, despite manufacturer specification of ±5% accuracy, suggesting proper technique as a major factor in small-volume measurements. Conclusion: In addition to proper, validated training of
syringe users, we recommend that users measure no less than 20% of the indicated volume of the
syringe while choosing syringes as close as possible to the desired measurement. When possible, very small volumes should be diluted to meet the minimum volume of the smallest
syringe available. Implementation of these recommendations will improve accurate dosing and, ultimately, patient safety.