Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo

Schierl, Rudolf; Masini, Carla; Groeneveld, Svenja; Fischer, E.; Böhlandt, Antje; Rosini, Valeria; Paolucci, D

doi:10.1177/1078155214551316

Cited by 34 publications

(47 citation statements)

References 16 publications

(17 reference statements)

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“…Recently, a wipe test investigated environmental and product contaminations by CPA in the robotic preparation with APOTECAchemo and manual preparation was published [16]. This report showed that the contamination of CPA was observed on the operator’s gloves (4 of 7: 0.0004-0.0967 ng/cm 2 ) and the majority (70%) of infusion bags during manual preparation.…”

Section: Discussionmentioning

confidence: 99%

Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Iwamoto

Morikawa

Hioki

et al. 2017

J Pharm Health Care Sci

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BackgroundThe accuracy, safety and feasibility of, the compounding robot APOTECAchemo were evaluated in the clinical practice of Japan.MethodsAccuracy and precision of robotic preparations by APOTECAchemo was evaluated in 20 preparations of fluorouracil (FU) and cyclophosphamide (CPA) infusions by four pharmacists. Environmental and product contaminations with FU and CPA were evaluated by wipe testing. Robotic performance was compared with manual preparation in a biological safety cabinet. The number of robotic products, total compounding time and total pre-reconstitution time of lyophilized drugs between January 1, 2014 to December 31, 2015 were investigated.ResultsRobotic preparation resulted more accurate and precise (mean absolute dose error and coefficient of variation were 0.83 and 1.04% for FU and 0.52 and 0.59% for CPA) than those of manual preparation (respective values were 1.20 and 1.46% for FU and 1.70 and 2.20% for CPA). Drug residue was not detected from any of the prepared infusion bags with the robotic preparation, whereas FU was detected in two of four analyzed infusion bags with manual preparation. Average total time to make single anticancer drug preparation (compounding plus reconstitution of lyophilized drugs) was 6.11 min in the second half of 2015. During the study period, the highest percentage of production covered by APOTECAchemo was 70.4% of the total inpatient pharmacy activity.ConclusionRobotic preparation using APOTECAchemo should give substantial advantages in drug compounding for accuracy and safety and was able to be successfully worked in Mie university hospital.

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Section: Discussionmentioning

confidence: 99%

Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Iwamoto

Morikawa

Hioki

et al. 2017

J Pharm Health Care Sci

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“…The first experiences in automated antineoplastic drug preparation have been published in 19902 and various experiences with fully automated robots followed more than one decade later,3 4 but approaches and local conditions that influence use and output of the device are different. In addition, there is already evidence that robotic devices are able to produce very low contamination levels,5 and therefore, might be capable of enhancing staff safety 6…”

Section: Introductionmentioning

confidence: 99%

Semiautomated aseptic preparation of patient-individual antineoplastic intravenous solutions: first experiences in a German hospital pharmacy

et al. 2015

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Objectives In 2013, the PharmaHelp device was introduced to daily patient care at the University Hospital of Heidelberg in order to improve process and staff safety and health. It is a semiautomated device located in a safety workbench for aseptic preparation with weight-and-visual-supported process check as well as radio-frequency identification of bags and vials. Methods After qualification and a training period, several high-admixture-volume drugs were chosen stepwise to be prepared by the device. During a reporting period of 6 months, the number of processed production runs and produced bags were assessed as well as the productivity per hour of the device based on the processed admixing volume and time consumption for manual preprocessing and postprocessing steps.

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“…Our results imply smaller contamination rates for both manual and robotic compounding than previous research did. Earlier studies suggested that variability in surface contamination could be associated with different methods of drug preparation, which can influence work techniques, that is proximity of the storage area relative to the preparation area, as well as the size of the compounding area where drugs are handled.…”

Section: Discussionmentioning

confidence: 41%

“…compared contamination with cyclophosphamide prepared using a manual procedure in a BSC to robotic‐assisted compounding using APOTECAchemo by measuring traces on the outside of prepared infusions. This study concluded that the total cyclophosphamide contamination was lower when the production was performed by the closed and controlled robotic system . Another study carried out by Iwamoto et al .…”

Section: Introductionmentioning

confidence: 76%

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The assessment of environmental and external cross-contamination in preparing ready-to-administer cytotoxic drugs: a comparison between a robotic system and conventional manual production

Buning

Geersing

Crul

2019

International Journal of Pharmacy Practice

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Objectives The primary aim of the study was to compare environmental and external (cross-) contamination of traces of cytostatics, during preparation of 5-fluorouracil and cyclophosphamide using a robotic system (APOTECAchemo) or the conventional manual compounding procedure. The secondary aim was to validate the cleaning procedure of the robot. Methods Eighty ready-to-administer (RTA) infusion bags with 5-fluorouracil, cyclophosphamide or sodium chloride were compounded using both techniques on 3-5 days. Wipe samples were taken from several locations in the compounding room before and after cleaning, and also from the technician's gloves. These samples were analysed for 5-fluorouracil and cyclophosphamide concentrations using GC/MS/MS. Key findings A total of 284 wipe samples were collected during the study (113 from the manual and 171 from the robotic process). External contamination on the outside of infusion bags was 3.75% for both manual and robotic compounding. For manual compounding, external cross-contamination occurred on 2.5% of the prepared infusion bags. External cross-contamination occurred on 1.25% of the infusion bags for the robotic procedure. Inside the compounding room, 9% of the environmental wipe samples were contaminated in case of manual production and 24% for robotic compounding. Since 50% of the contaminated environmental samples for the robotic system were taken after cleaning, the cleaning procedure was extended and parameter setting for cyclophosphamide handling was performed. After this, residual environmental or external contamination was no longer detectable. Conclusion Comparison of both preparation methods showed that external (cross-)contamination of infusion bags was lower using the robotic system. An optimized cleaning procedure showed the best results in environmental contamination for the robot.

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Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo

Cited by 34 publications

References 16 publications

Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

Semiautomated aseptic preparation of patient-individual antineoplastic intravenous solutions: first experiences in a German hospital pharmacy

The assessment of environmental and external cross-contamination in preparing ready-to-administer cytotoxic drugs: a comparison between a robotic system and conventional manual production

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