scholarly journals Evaluation of the efficacy of a self-cleaning automated compounding system for the decontamination of cytotoxic drugs

2020 ◽  
pp. 107815522095186
Author(s):  
Naiara Telleria ◽  
Nerea García ◽  
Jaione Grisaleña ◽  
Naiara Algaba ◽  
Eider Bergareche ◽  
...  
Keyword(s):  
Reference Value ◽  
Cytotoxic Drugs ◽  
Surface Contamination ◽  
Limit Of Quantification ◽  
Wipe Sampling ◽  
Cleaning Procedures ◽  
Self Cleaning ◽  
Contamination Levels ◽  
Cleaning Methods ◽  
Hazardous Drugs

Introduction 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. Methods 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. Results 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/cm2 (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/cm2). For surface contamination levels when spiking with 100 ng/cm2, both self-cleaning methods had decontamination efficacies >99.8% for all cytotoxic drugs analyzed. Conclusion 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.

scholarly journals Environmental and Product Contamination during the Preparation of Antineoplastic Drugs with Robotic Systems

2018 ◽  
Vol 3 (3) ◽  
pp. 153-164 ◽  
Author(s):  
Irene Krämer ◽  
Matteo Federici ◽  
Rudolf Schierl
Keyword(s):  
Outer Surface ◽  
Standardized Test ◽  
Robotic System ◽  
Surface Contamination ◽  
Robotic Systems ◽  
Antineoplastic Drugs ◽  
Wipe Sampling ◽  
Before And After ◽  
Cleaning Procedures ◽  
Contamination Levels

AbstractBackgroundRobotic systems are designed to minimize the exposure to antineoplastic drugs during automated preparation. However, contamination cannot be completely excluded. The aim of the study was to evaluate the contamination with antineoplastic drugs on the working surfaces and on the outer surface of the ready-to-use products (infusion bags and syringes) during automated preparation with different versions of a robot and manual preparation.MethodsSurface contamination with platinum (Pt) and 5-fluorouracil (5-FU) was measured by wipe sampling and quantified by voltammetry for Pt and GC-MS for 5-FU. Sampling was performed on pre-defined locations in the working areas before and after preparation of standardized test products. The outer surfaces of Pt- or 5-FU-containing infusion bags and 5-FU-containing syringes were sampled without and after manual capping.ResultsOverall, the surface contamination in the working areas of the robotic system ranged from 0.4 to 114 pg/cm2for Pt and from 1.3 to 1,250,000 pg/cm2for 5-FU. The highest contamination levels were detected after preparation on the gripper of the robotic arm and on the surface beneath the dosing device. In most cases, measured concentrations were higher after preparation. Outer surfaces of infusion bags prepared with the robotic system were less contaminated than manually prepared bags. Contamination on the outer surface of syringes varied depending on the procedure adopted.ConclusionsThe risk of contamination is localised inside the working area of the robot. The outer surfaces of products were only marginally contaminated. Cleaning procedures of the working area are to be further investigated. An effective decontamination procedure for the working area of the robot and automated capping of filled syringes should be developed to further minimize the occupational risk.

scholarly journals New Approaches to Wipe Sampling Methods for Antineoplastic and Other Hazardous Drugs in Healthcare Settings

2016 ◽  
Vol 1 (3) ◽  
Author(s):  
Thomas H. Connor ◽  
Jerome P. Smith
Keyword(s):  
New Technology ◽  
Sampling Strategy ◽  
Analytical Techniques ◽  
Surface Contamination ◽  
Antineoplastic Drugs ◽  
Sample Analysis ◽  
Healthcare Settings ◽  
Wipe Sampling ◽  
Hazardous Drugs ◽  
Review Current

Abstract: At the present time, the method of choice to determine surface contamination of the workplace with antineoplastic and other hazardous drugs is surface wipe sampling and subsequent sample analysis with various analytical techniques. The purpose of this article is to review current methodology for determining the level of surface contamination with hazardous drugs in healthcare settings and to discuss recent advances in this area. In addition it will provide some guidance for conducting surface wipe sampling and sample analysis for these drugs in healthcare settings.: Published studies on the use of wipe sampling to measure hazardous chemicals, including antineoplastic drugs on surfaces were reviewed. These studies include the use of well-documented chromatographic techniques for sample analysis in addition to newly evolving technology that provides rapid analysis of specific antineoplastic drugs.: Methodology for the analysis of surface wipe samples for hazardous drugs are reviewed, including the purposes, technical factors, sampling strategy, materials required, and limitations. The use of lateral flow immunoassay (LFIA) and fluorescence covalent microbead immunosorbent assay (FCMIA) for surface wipe sample evaluation is also discussed.: Current recommendations are that all healthcare settings where antineoplastic and other hazardous drugs are handled include surface wipe sampling as part of a comprehensive hazardous drug-safe handling program. Surface wipe sampling may be used as a method to characterize potential occupational dermal exposure risk and to evaluate the effectiveness of implemented controls and the overall safety program. New technology, although currently limited in scope, may make wipe sampling for hazardous drugs more routine, less costly, and provide a shorter response time than classical analytical techniques now in use.

Effectiveness of a decontamination procedure in a pharmacy buffer room contaminated by 5 antineoplastic agents

2020 ◽  
Vol 77 (24) ◽  
pp. 2081-2088
Author(s):  
Paul Arpino ◽  
Jason Yeomelakis ◽  
Anisha Oommen
Keyword(s):  
Pharmacy Staff ◽  
Healthcare Facilities ◽  
Wipe Sampling ◽  
Sufficient Detail ◽  
Before And After ◽  
The Mean ◽  
Pharmacy Technicians ◽  
Contamination Levels ◽  
The Impact ◽  
Hazardous Drugs

Abstract Purpose Healthcare facilities are obligated to implement strategies to protect healthcare workers from exposure to hazardous drugs, including any real or potential risk from contaminated surfaces. Guidelines are broad and lack sufficient detail for healthcare facilities to establish clear effectiveness targets for their decontamination procedures. Our goal in this analysis was to measure the effectiveness of a decontamination procedure in a pharmacy buffer room contaminated with 5 antineoplastic drugs. Methods Six rounds of contamination, decontamination, and wipe sampling were performed in a pharmacy buffer room designated for hazardous drug (HD) compounding. Ten locations in the buffer room were contaminated with 5-fluorouracil, carboplatin, cyclophosphamide, paclitaxel, and doxorubicin. Pharmacy staff were blinded to contamination sites. After contamination, 3 pharmacy technicians following the same decontamination procedure decontaminated the buffer room. To assess the impact of decontamination, residual hazardous drug levels were assessed after contamination and after decontamination using a commercially available wipe sampling product. Results The mean (SD) residual contamination levels for the 239 wipe samples taken before and after decontamination were 63 (60) ng and 3.9 (8.2) ng, respectively, representing a 94% reduction in residual HD contamination. Residual contamination was not detectable (&lt;5 ng) in 221 (~93%) of the samples after decontamination. Conclusion The employed decontamination procedures effectively reduced residual HD surface contamination.

scholarly journals Comparison of Decontamination Efficacy of Cleaning Solutions on a Biological Safety Cabinet Workbench Contaminated by Cyclophosphamide

2017 ◽  
Vol 70 (6) ◽  
Author(s):  
Apolline Adé ◽  
Laure Chauchat ◽  
Johann-François Ouellette Frève ◽  
Sébastien Gagné ◽  
Nicolas Caron ◽  
...  
Keyword(s):  
Sodium Hypochlorite ◽  
Quaternary Ammonium ◽  
Recovery Efficiency ◽  
Main Study ◽  
Biological Safety ◽  
Wipe Sampling ◽  
Cleaning Solution ◽  
Cleaning Procedures ◽  
Majeure Partie ◽  
Hazardous Drugs

<p><strong>ABSTRACT</strong></p><p><strong>Background:</strong> Several studies have compared cleaning procedures for decontaminating surfaces exposed to antineoplastic drugs. All of the cleaning products tested were successful in reducing most of the antineoplastic drug quantities spilled on surfaces, but none of them completely<br />removed residual traces.</p><p><strong>Objective:</strong> To assess the efficacy of various cleaning solutions for decontaminating a biological safety cabinet workbench exposed to a defined amount of cyclophosphamide.</p><p><strong>Methods:</strong> In this pilot study, specific areas of 2 biological safety cabinets (class II, type B2) were deliberately contaminated with a defined quantity of cyclophosphamide (10 μg or 107 pg). Three cleaning solutions were tested: quaternary ammonium, sodium hypochlorite 0.02%, and sodium hypochlorite 2%. After cleaning, the cyclophosphamide remaining on the areas was quantified by wipe sampling. Each cleaning solution was tested 3 times, with cleaning and wipe sampling being performed 5 times for each test.</p><p><strong>Results:</strong> A total of 57 wipe samples were collected and analyzed. The average recovery efficiency was 121.690% (standard deviation 5.058%). The decontamination efficacy increased with the number of successive cleaning sessions: from 98.710% after session 1 to 99.997% after session 5 for quaternary ammonium; from 97.027% to 99.997% for sodium hypochlorite 0.02%; and from 98.008% to 100% for sodium hypochlorite 2%. Five additional cleaning sessions performed after the main study (with detergent and sodium hypochlorite 2%) were effective to complete the decontamination, leaving no detectable traces of the drug.</p><p><strong>Conclusions:</strong> All of the cleaning solutions reduced contamination of biological safety cabinet workbenches exposed to a defined amount of cyclophosphamide. Quaternary ammonium and sodium hypochlorite (0.02% and 2%) had mean efficacy greater than 97% for removal of the initial quantity of the drug (107 pg) after the first cleaning session. When sodium hypochlorite 2% was used, fewer cleaning sessions were required to complete decontamination. Further studies should be conducted to identify optimal cleaning strategies to fully eliminate traces of hazardous drugs.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte :</strong> Bon nombre d’études ont comparé les méthodes de nettoyage pour décontaminer les surfaces exposées aux antinéoplasiques. Toutes les solutions de nettoyage évaluées permettaient d’enlever la majeure partie des quantités d’antinéoplasiques renversés sur les surfaces, mais aucune n’arrivait à éliminer les traces résiduelles.</p><p><strong>Objectif :</strong> Évaluer l’efficacité de différentes solutions de nettoyage servant à décontaminer une enceinte de sécurité biologique exposée à une quantité précise de cyclophosphamide.</p><p><strong>Méthodes :</strong> Dans la présente étude pilote, des zones déterminées de deux enceintes biologiques (classe II, type B2) ont été délibérément contaminées avec une quantité précise de cyclophosphamide (10 μg ou 107 pg). Trois solutions de nettoyage ont été évaluées : l’ammonium quaternaire, l’hypochlorite de sodium à 0,02 % et l’hypochlorite de sodium à 2 %. Après nettoyage, le cyclophosphamide toujours présent sur les surfaces était quantifié à l’aide de prélèvements par lingette. Chaque solution de nettoyage a été évaluée trois fois, tandis que le nettoyage et le prélèvement par lingette ont été répétés cinq fois pour chaque test.</p><p><strong>Résultats :</strong> Au total, on a recueilli et analysé 57 lingettes ayant servi à l’échantillonnage. Le taux moyen d’efficacité de récupération était de 121,690 % (écart-type de 5,058 %). L’efficacité de la décontamination augmentait en fonction du nombre de séances successives de nettoyage : de 98,710 % après le premier nettoyage à 99,997 % après le cinquième nettoyage pour l’ammonium quaternaire; de 97,027 % à 99,997 % pour l’hypochlorite de sodium à 0,02 %; et de 98,008 % à 100 % pour l’hypochlorite de sodium à 2 %. Après l’étude principale, cinq séances de nettoyage supplémentaires (avec détergent et hypochlorite de sodium à 2%) ont permis de terminer la décontamination, ne laissant aucune trace détectable du médicament.</p><p><strong>Conclusions :</strong> Toutes les solutions de nettoyage réduisaient la contamination d’une enceinte de sécurité biologique exposée à une quantité précise de cyclophosphamide. L’efficacité moyenne de l’ammonium quaternaire et de l’hypochlorite de sodium (à 0,02 % et à 2 %) pour éliminer la quantité initiale de 107 pg du médicament s’élevait à plus de 97 % après la première séance de nettoyage. Lorsque l’hypochlorite de sodium à 2 % était employé, un moins grand nombre de séances de nettoyage était nécessaire pour terminer la décontamination. De plus amples études sont nécessaires afin de pouvoir trouver des stratégies de nettoyage optimales permettant d’éliminer entièrement les traces de médicaments dangereux.</p>

scholarly journals Six ultraviolet minutes for cleaner operating theatres

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
R Bosco ◽  
S Gambelli ◽  
V Urbano ◽  
G Cevenini ◽  
G Messina
Keyword(s):  
Cross Sectional Study ◽  
Cross Sectional ◽  
Before And After ◽  
Operating Theatres ◽  
Cleaning Procedures ◽  
The Difference ◽  
Contamination Levels ◽  
Different Levels ◽  
Better Than ◽  
Final Cleaning

Abstract Background Sanitizing the operating theatres (OT) is important to minimize risk of post-operative infections. Disinfection procedures between one operation and another is less aggressive than final cleaning procedures, at the end of the day. Aim was assessing the difference of contamination: i) between different levels of disinfection; ii) before and after the use of a UVC Device (UVC-D). Methods Between December 2019/February 2020 a cross sectional study was conducted in OT in a real clinical context. 94 Petri dishes (PD) were used in 3 OT. Three different sanitation levels (SL1-3) were compared pre- and post-use of UVC-D: i) No cleaning after surgery (SL1); ii) after in-between cleaning (SL2); iii) after terminal cleaning (SL3). UVC-D was employed for 6 minutes, 3 minutes per bed side. PD were incubated at 36 °C and colony forming unit (CFU) counted at 48h. Descriptive statistic, Wilcoxon and Mann-Whitney tests were performed to assess the contamination levels in total, pre/post use of UVC-D, and between different sanitation levels, respectively. Results In total we had a mean of 3.39 CFU/PD (C.I. 2.05 - 4.74) and a median of 1 CFU/PD (Min. 0 - Max. 39), after UVC-D use we had a mean of 2.20 CFU/PD (C.I. 0.69 - 5.09) and a median of 0 CFU/PD (Min. 0 - Max. 133). The UVC-D led to a significant reduction of CFU (p &lt; 0.001). Without UVC-D we had a significant CFU drop (p &lt; 0.05) between SL1 and SL3. Using UVC-D, we observed significant reductions of contamination (p &lt; 0.05) between SL3 and SL1. Comparing SL1 (median 0) post UVC-D use vs SL2 pre UVC-D use (median 0.5), and SL2 post UVC-D use (median 0) vs SL3 pre UVC-D use (median 1) we had a significant reduction of contamination (p &lt; 0.05). Conclusions UVC-D improved environmental contamination in any of the three sanitation levels. Furthermore, the use of UVC-D alone was better than in-between and terminal cleaning. Although these encouraging results, the cleaning procedures executed by dedicated staff has to be considered. Key messages UVC are efficient to decrease contamination in operating theatres regardless of sanitation levels. The additional use of UVC technology to standard cleaning procedures significantly improves sanitation levels.

scholarly journals Evaluation of external contamination on the vial surfaces of some hazardous drugs that commonly used in Chinese hospitals and comparison between environmental contamination generated during robotic compounding by IV: Dispensing robot vs. manual compounding in biological safety cabinet

2021 ◽  
pp. 107815522110235
Author(s):  
Hao ML ◽  
Wang T ◽  
Zhu JQ ◽  
Song YJ ◽  
Gong TJ ◽  
...  
Keyword(s):  
Environmental Contamination ◽  
High Performance ◽  
Surface Contamination ◽  
Comparison Analysis ◽  
Sample Analysis ◽  
Average Amount ◽  
External Contamination ◽  
Biological Safety ◽  
Double Mass ◽  
Hazardous Drugs

Objectives The aims of the study were to evaluate the external contamination of hazardous drug vials used in Chinese hospitals and to compare environmental contamination generated by a robotic intelligent dispensing system (WEINAS) and a manual compounding procedure using a biological safety cabinet (BSC). Methods Cyclophosphamide, fluorouracil, and gemcitabine were selected as the representative hazardous drugs to monitor surface contamination of vials. In the comparative analysis of environmental contamination from manual and robotic compounding, wipe samples were taken from infusion bags, gloves, and the different locations of the BSC and the WEINAS robotic system. In this study, high-performance liquid chromatography coupled with double mass spectrometer (HPLC-MS/MS) was employed for sample analysis. Results (1) External contamination was measured on vials of all three hazardous drugs. The contamination detected on fluorouracil vials was the highest with an average amount up to 904.33 ng/vial, followed by cyclophosphamide (43.51 ng/vial), and gemcitabine (unprotected vials of 5.92 ng/vial, protected vials of 0.66 ng/vial); (2) overall, the environmental contamination induced by WEINAS robotic compounding was significantly reduced compared to that by manual compounding inside the BSC. Particularly, compared with manual compounding, the surface contamination on the infusion bags during robotic compounding was nearly nine times lower for cyclophosphamide (10.62 ng/cm2 vs 90.43 ng/cm2), two times lower for fluorouracil (3.47 vs 7.52 ng/cm2), and more than 23 times lower for gemcitabine (2.61 ng/cm2 vs 62.28 ng/cm2). Conclusions The external contamination occurred extensively on some hazardous drug vials that commonly used in Chinese hospitals. Comparison analysis for both compounding procedures revealed that robotic compounding can remarkably reduce environmental contamination.

scholarly journals Impact of educational intervention on knowledge regarding safe handling of cytotoxic drugs among the nursing personnel working in BPKIHS

2017 ◽  
Vol 13 (1) ◽  
pp. 13-22
Author(s):  
Dev Kumari Shrestha (Rai) ◽  
S Lama ◽  
A Badu ◽  
G N Mandal
Keyword(s):  
Health Care ◽  
Educational Intervention ◽  
Cytotoxic Drugs ◽  
Nursing Personnel ◽  
Drug Preparation ◽  
Safe Handling ◽  
National Organizations ◽  
Post Test ◽  
The Difference ◽  
Hazardous Drugs

Introduction: Cytotoxic drugs are toxic compounds and are known to have carcinogenic, mutagenic and/or teratogenic potential. It is also considered as hazardous drugs. With direct contact they may cause irritation to the skin, eyes, and mucous membranes, and ulceration and necrosis of tissue. Safe handling refers to the process in which health care workers adhere to evidence-based practices (EBP) set forth by national organizations that have been designed to eliminate or significantly reduce occupational exposure. The key to safe handling is to protect the health care worker throughout the three phases of contact with the hazardous drugs. These phases are drug preparation, administration and disposal.Objective: To assess the effectiveness of education in enhancing the knowledge regarding safe handling of cytotoxic drugs among nursing personnel working at BPKIHS.Methods: Fifty nurses were taken as sample from selected ward of BPKIHS. One group pretest post test design was used by using population enumeration methods.Results: The overall mean score of knowledge on safe handling cytotoxic drugs of the respondents were 35.3 in the pre-test which increased to 83.7 in the post-test after an educational intervention. The difference was significant (p<0.001).Conclusion: Thus, the study's findings highlighted that there was a significant improvement in knowledge of the staffs after educational intervention. The educational intervention was very effective to improve the knowledge of the staffs. Health Renaissance 2015;13 (1): 

scholarly journals Total Fat Gravimetric Method Workflow in Portuguese Olives Using Closed-Vessel Microwave-Assisted Extraction (MAE)

Foods ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. 2364
Author(s):  
João Gonçalo Lourenço ◽  
Daniel Ettlin ◽  
Inês Carrero Cardoso ◽  
Jesus M. Rodilla
Keyword(s):  
Limit Of Detection ◽  
Gravimetric Method ◽  
Reference Value ◽  
Microwave Assisted Extraction ◽  
Closed Vessel ◽  
Limit Of Quantification ◽  
Microwave Assisted ◽  
Assisted Extraction ◽  
Total Fat

A simple and rapid method for the quantitation of total fat in olive samples is designed, evaluated, and presented. This method is based on an innovative closed-vessel microwave-assisted extraction (MAE) technique. A method was designed for olives, and some figures of merits were evaluated: limit of detection (LOD), limit of quantification (LOQ) and expanded uncertainty (U). The data obtained in these experiences show that the workflow of the MAE method in a closed container is statistically equivalent to the other two methods, showing in this case better performance indicators (LOD = 0.02%, LOQ = 0.06%, and U = 15%). In addition, it is also demonstrated that the complete MAE method workflow allows the determination of total fat in a maximum of 12 analyses simultaneously for about 100 min in each run, which is the capacity of the rotor. This is a much better productivity when compared to the traditional Soxhlet-based method. Considering the sample workflow, the closed-vessel MAE method greatly simplifies sample handling, therefore minimizing sample loss during sample preparation and reducing analysis time. When MAE is compared to NIR-based methods, the advantage comes from there being no need for any type of calibration in the sample matrix. The MAE method itself can be used to determine the reference value for NIR calibration purposes. The results obtained for CRM using MAE were equivalent to the ones shown on the certificate.

scholarly journals 3PC-041 Surface contamination with cytotoxic drugs in European hospital wards

2020 ◽  
Author(s):  
E Korczowska ◽  
H Jankowiak-Gracz ◽  
M Crul ◽  
J Tuerk ◽  
D Arnold ◽  
...  
Keyword(s):  
Cytotoxic Drugs ◽  
Surface Contamination ◽  
Hospital Wards
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