Myriam Bouchfaa, Michèle Vasseur, Justin Courtin, Marine Pinturaud, Nicolas Beauval, Delphine Allorge, Pascal Odou, Nicolas Simon
{"title":"在使用 RIVATM 化合机器人过程中对抗癌药物化学污染的评估:试点研究。","authors":"Myriam Bouchfaa, Michèle Vasseur, Justin Courtin, Marine Pinturaud, Nicolas Beauval, Delphine Allorge, Pascal Odou, Nicolas Simon","doi":"10.1177/10781552241276530","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVA<sup>TM</sup> robot (ARxIUM, Winnipeg, Canada).</p><p><strong>Material & methods: </strong>We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CR<sub>in</sub>) and outside (CR<sub>out</sub>) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented.</p><p><strong>Results: </strong>Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CR<sub>in</sub> (40%) was significantly higher than the mean CR<sub>out</sub> (2%; p < 10<sup>-4</sup>). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CR<sub>in</sub> fell from 60% to 10%.</p><p><strong>Discussion/conclusion: </strong>The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assessment of chemical contamination by cancer drugs during use of the RIVA<sup>TM</sup> compounding robot: A pilot study.\",\"authors\":\"Myriam Bouchfaa, Michèle Vasseur, Justin Courtin, Marine Pinturaud, Nicolas Beauval, Delphine Allorge, Pascal Odou, Nicolas Simon\",\"doi\":\"10.1177/10781552241276530\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVA<sup>TM</sup> robot (ARxIUM, Winnipeg, Canada).</p><p><strong>Material & methods: </strong>We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CR<sub>in</sub>) and outside (CR<sub>out</sub>) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented.</p><p><strong>Results: </strong>Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CR<sub>in</sub> (40%) was significantly higher than the mean CR<sub>out</sub> (2%; p < 10<sup>-4</sup>). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CR<sub>in</sub> fell from 60% to 10%.</p><p><strong>Discussion/conclusion: </strong>The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. 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Assessment of chemical contamination by cancer drugs during use of the RIVATM compounding robot: A pilot study.
Introduction: Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVATM robot (ARxIUM, Winnipeg, Canada).
Material & methods: We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CRin) and outside (CRout) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented.
Results: Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CRin (40%) was significantly higher than the mean CRout (2%; p < 10-4). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CRin fell from 60% to 10%.
Discussion/conclusion: The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results.
期刊介绍:
Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...