Pharmacy, University Hospital Centre Grenoble Alpes, Grenoble, Auvergne-Rhone-Alpes, France
Faculty of pharmacy, Univ. Grenoble Alpes, Saint-Martin-d'Heres, Rhône-Alpes, France.
Eur J Hosp Pharm. 2023 Nov;30(6):347-352. doi: 10.1136/ejhpharm-2021-002993. Epub 2021 Dec 31.
Automation of parenteral nutrition (PN) preparation is nowadays a recommended practice in order to reduce human errors and thus improve the safety and accuracy of the finished product. Other benefits of automation may include full documentation of preparation and a reduction in personnel requirements or staff injuries. The market of automation compounding presents different automated compounding devices (ACDs). The aim of this study is to compare the technical characteristics of ACDs by carrying out four specific challenges.
Three ACDs: Two piston pumps with ACD 1: MediMix Multi 4120R (Impromediform) and ACD 2: Mibmix Compounder C12 (Hemedis), and one peristaltic pump ACD 3: ExactaMix Compounder EM2400 (Baxter) were assessed in a pharmaceutical manufacturing unit within a controlled atmosphere area, under horizontal laminar flow hood (LFH) according to four tests: volumetric accuracy, flush volume, smoke test, and a production test with three configurations of PN bags. For this test, a PN bag was considered accepted when all quality controls (weight, molar concentration of sodium, potassium and calcium) were fulfilled.
The maximum relative biases found for the different ACDs were heterogeneous. ACD 1 had the best volumetric accuracy with respect to supplier specifications and for extreme volumes (0.2 mL). Evaluation of the flushing volume allowed the validation of 50 mL volumes for ACD 1 and ACD 3. The smoke test was only conclusive for ACD 1 under a horizontal LFH. The percentage of PN bags accepted were 98.8% for ACD 1, 70% for ACD 2%, and 95.5% for ACD 3.
This study compared three ACDs according to four relevant and specific tests. Based on the data acquired, we conclude that ACD 1 is the most accurate, has the lowest flushing volume, is suitable for use in a LFH, and achieves the best results in the production test.
肠外营养（PN）制备的自动化如今是一种推荐的做法，以减少人为错误，从而提高成品的安全性和准确性。自动化的其他好处可能包括制备的完整记录以及减少人员需求或员工受伤。自动化混合的市场提供了不同的自动化混合设备（ACD）。本研究的目的是通过进行四项具体挑战来比较 ACD 的技术特征。
在制药生产单元中，在受控气氛区域内，在水平层流罩（LFH）下，使用三种 ACD 进行评估：两种活塞泵，ACD1：MediMix Multi 4120R（Impromediform）和 ACD2：Mibmix 配药器 C12（Hemedis），以及一种蠕动泵 ACD3：ExactaMix 配药器 EM2400（Baxter），根据四项测试：体积准确性、冲洗量、烟雾测试和三种 PN 袋配置的生产测试。对于此测试，当所有质量控制（重量、钠、钾和钙的摩尔浓度）都满足时，PN 袋被认为是合格的。
不同 ACD 的最大相对偏差是异构的。ACD1 相对于供应商规格和极端体积（0.2 毫升）具有最佳的体积准确性。冲洗量的评估验证了 ACD1 和 ACD3 的 50 毫升体积。只有在水平 LFH 下，烟雾测试才对 ACD1 具有结论性。ACD1 的 PN 袋合格率为 98.8%，ACD2 为 70%，ACD3 为 95.5%。
本研究根据四项相关和具体的测试比较了三种 ACD。根据获得的数据，我们得出结论，ACD1 是最准确的，冲洗量最低，适用于 LFH 使用，并且在生产测试中取得了最佳结果。
