Analytical Control by UV Spectrophotometry with DRUGLOG^®: Relevance for In-House Calibration Ranges?

DRUGLOG^® is a UV-visible spectrophotometry-based automated system used since 2022 in our Chemotherapy Preparation Unit (UPC) to perform quality control on 40% of preparations (11,000 per year). Analyses are based on calibration ranges provided by the manufacturer, derived from a shared database between centers. After the recommissioning of the equipment (following unit renovation), a 15% rate of quantitative non-conformities — with concentration deviations exceeding the ±15% tolerance threshold — raised concerns about the reliability of the results obtained.

A study was therefore conducted to compare the performance of locally prepared calibration ranges with those supplied by the manufacturer. The aim is to ensure the reliability of the manufacturer’s ranges and to select the most appropriate for each drug to secure the control process.

The study focused on four commonly used cytotoxic drugs (5-fluorouracil, paclitaxel, irinotecan, oxaliplatin). In-house calibration ranges were prepared and validated by repeatability tests over three days. Samples from infusion bags were analyzed in parallel using both sets of ranges over a two-week period (compliance threshold: ±15%).

In total, 57 infusion bag preparations were analyzed. For 5FU (n=16), a compliance rate of 94% was achieved with the in-house range (1 qualitative NC, 1 quantitative NC), compared to 81% with the DRUGLOG^® range (3 quantitative NCs). Irinotecan (n=10) showed 100% compliance with the DRUGLOG^® range, but only 30% with the in-house range (7 qualitative NCs). For oxaliplatin (n=17), DRUGLOG^® showed better compliance (100% vs. 82%), with 3 qualitative NCs observed using the in-house range. Paclitaxel (n=14) was 100% compliant with both calibration ranges.

The results show variability in performance depending on the drug and the calibration range used. This study highlights the need of a closer partnership with the manufacturer to adapt or optimize calibration ranges in order to ensure reliable, reproducible, and safe quality control in routine practice.

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