Combeau D, Rey J B, Fontan J E, Nouaille-Degorce B, Brion F
Service Pharmacie et Laboratoire de Toxico-pharmacologie, Hôpital Robert Debré AP-HP, Paris, France.
PDA J Pharm Sci Technol. 1999 Sep-Oct;53(5):226-30.
The constant increase of parenteral nutrition (PN) manufacturing in our pediatric hospital led us to look for an automatic filling system. The aim of this study was to evaluate the MicroMacrocompounder (MM23) for compounding pediatric PN solutions. MM23 volumetric accuracy was tested with its different inlets (S, D, V) for volumes of sterile water for injection from 0.2 to 2900 mL. The influence of the solution viscosity and the source solution bottle replacements during the filling operation was also investigated. Manufacturing pediatric PN solutions was eventually assessed. Time to set up the system was 30 minutes. Maximum filling speeds with sterile water for injection were 860, 330, 154 mL/min for Vx, V and D inlets, respectively. Inlet S was not tested for MM23 filling speed. Minimal flush volume of 40 mL of sterile water for injection is necessary to clear the tube of residual ions. Average MM23 volumetric accuracy was < 5% for volumes > or = 0.5 mL for S and D inlets, and for volumes > or = 20 mL for V inlet. The volumetric accuracy was equal to 6.25% for 0.2 mL. In all experiments, volumetric accuracy was < 5%. The accuracy of electrolyte measurements performed on bag samples was less than 5% for 150 (74%) samples, between 5 and 10% for 27 (13%) samples and greater than 10% for 27 (13%) samples. Microbiological analysis showed no positive culture. The average manufacturing times were 56.8 +/- 4.5, 188.2 +/- 7.7 and 447.2 +/- 13.8 seconds for 130, 660 and 1800 mL bags, respectively. The MM23 compounder is suitable for compounding pediatric admixtures with source solutions volumes > or = 0.5 mL. This system has been used daily for five months in our department.
我们儿科医院肠外营养（PN）制剂的持续增长促使我们寻找一种自动灌装系统。本研究的目的是评估MicroMacro复合机（MM23）用于配制儿科PN溶液的情况。对MM23的不同入口（S、D、V）进行了容量准确性测试，测试的注射用水体积范围为0.2至2900 mL。还研究了溶液粘度和灌装操作过程中源溶液瓶更换的影响。最终对儿科PN溶液的配制进行了评估。系统设置时间为30分钟。注射用水的最大灌装速度分别为：Vx入口860 mL/分钟、V入口330 mL/分钟、D入口154 mL/分钟。未对入口S进行MM23灌装速度测试。需要至少40 mL注射用水进行最小冲洗量，以清除管道中的残留离子。对于S和D入口，体积≥0.5 mL时，MM23的平均容量准确性<5%；对于V入口，体积≥20 mL时，MM23的平均容量准确性<5%。0.2 mL时的容量准确性为6.25%。在所有实验中，容量准确性均<5%。对袋装样品进行的电解质测量准确性：150个（74%）样品<5%，27个（13%）样品在5%至10%之间，27个（13%）样品>10%。微生物分析显示无阳性培养结果。130 mL、660 mL和1800 mL袋装的平均配制时间分别为56.8±4.5秒、188.2±7.7秒和447.2±13.8秒。MM23复合机适用于配制源溶液体积≥0.5 mL的儿科混合制剂。该系统已在我们科室每日使用了五个月。
