Pharmacy Department, KIRO Grifols S.L., Arrasate, Gipuzkoa, Spain.
Hospital Pharmacy Department, Fundación Onkologikoa, Donostia, Gipuzkoa, Spain.
J Oncol Pharm Pract. 2021 Sep;27(6):1343-1353. doi: 10.1177/1078155220951866. Epub 2020 Aug 27.
Low surface contamination levels of hazardous drugs in compounding areas can be used as indicators of exposure and efficacy of cleaning procedures. We report the efficacy results of the KIRO® Oncology self-cleaning automated compounding system for decontamination of cytotoxic drugs, assessed in an oncology health center using a sanitizing method and an alkaline method.
The study was conducted for six-days over a three-week period. A mixture with known levels of 5-fluorouracil, ifosfamide, cyclophosphamide, gemcitabine, etoposide, methotrexate, paclitaxel, docetaxel and carboplatin was added to the KIRO® Oncology's compounding area surface before each self-cleaning method was used. Contamination levels were determined, with a surface wipe sampling kit, at the end of the self-cleaning process.
Background surface contamination for quantified levels of cytotoxic drugs during routine use of KIRO® Oncology was below limit of quantification (<LOQ) for all drugs, except for carboplatin, which has a very low LOQ (0.2 ng/sample). The quantified drug levels detected on surface wipe samples after self-cleaning using both methods in the KIRO® Oncology's compounding area surface sections were all <LOQ when spiking with 1 ng/cm (ten times the 'safe' reference value), except for carboplatin (alkaline method only), although its levels were still below the 'safe' reference value (0.1 ng/cm). For surface contamination levels when spiking with 100 ng/cm, both self-cleaning methods had decontamination efficacies >99.8% for all cytotoxic drugs analyzed.
This study provides evidence on the efficacy of the KIRO® Oncology automatic self-cleaning system for surface area decontamination during the preparation of cytotoxic drugs.
在配药区域中，有害药物的低表面污染水平可用作暴露和清洁程序效果的指标。我们报告了 KIRO® Oncology 自动清洁化合物系统在使用消毒方法和碱性方法的肿瘤学保健中心对细胞毒性药物进行去污的功效结果。
该研究在三周的时间内进行了六天。在每次使用自动清洁方法之前，将已知水平的 5-氟尿嘧啶、异环磷酰胺、环磷酰胺、吉西他滨、依托泊苷、甲氨蝶呤、紫杉醇、多西他赛和卡铂混合物添加到 KIRO® Oncology 的化合物区表面。在自动清洁过程结束时，使用表面擦拭取样试剂盒确定污染水平。
在常规使用 KIRO® Oncology 期间，除了卡铂（其 LOQ 非常低（0.2ng/sample））外，所有药物的背景表面污染对于细胞毒性药物的定量水平均低于定量下限（<LOQ）。在 KIRO® Oncology 化合物区表面部分使用两种方法进行自动清洁后，从表面擦拭样本中检测到的定量药物水平均<LOQ，当用 1ng/cm（“安全”参考值的十倍）进行加标时，除了卡铂（仅碱性方法），尽管其水平仍低于“安全”参考值（0.1ng/cm）。当用 100ng/cm 进行加标时，两种自动清洁方法对所有分析的细胞毒性药物的去污效率均>99.8%。
这项研究提供了证据，证明了 KIRO® Oncology 自动清洁系统在制备细胞毒性药物时对表面去污的功效。
