Productivity and aseptic process evaluation during batch production simulation of intravenous medications using a semi-automated compounding device.

Abstract

Introduction: Intravenous (IV) medications can be prepared using compounding devices to increase productivity, and reduce risks associated with aseptic compounding. This study evaluated the productivity and quality outcomes of the aseptic process for simulated batches of IV medications used in clinical practice produced using a semi-automated compounding device (Gri-fill; Grifols).

Methods: Simulated batches from 50 to 600 preparations were completed representing hazardous and non-hazardous drugs, including one-step single component (atropine sulfate, cisplatin) and multistep, multiple component (mitomycin C, piperacillin/tazobactam, trastuzumab, 5-fluorouracil and gemcitabine). Productivity, device autonomy, quality of the aseptic process (media-fill test) and sterility of the preparations were evaluated.

Results: A total of 2024 final preparations and 460 intermediate products were compounded during 78 working hours. For low and high complexity level preparations, median (minimum-maximum) production speed was 1.3 (0.6-1.7) and 3.7 (2.6-4.3) min per preparation, respectively. The longest process (36.2 min/bag) was the preparation of a simulated gemcitabine 3 L bulk solution bag, which included reconstitution of vials and filling the bulk bag. All operational errors (0.6%) were resolved autonomously by the user. None of the 883 media fill preparations showed microbiological growth and all 114 analyzed preparations passed the sterility test.

Conclusions: Using a semi-automated compounding device, preparation efficiency of IV medications ranged from 14 preparations/h for multicomponent preparations from vials requiring reconstitution, to 100 preparations/h for low complexity preparations using a bulk solution bag. The aseptic processes demonstrated the absence of microbial growth in all tested preparations.