Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal)

Author(s):  Garrigue Philippe, Montana Marc, Ventre Christophe, Savry Amadine, Gauthier-Villano Laurence, Pisano Pascale, Pourroy Bertrand

Issue:  Mar/Apr 2016 - Volume 20, Number 2
View All Articles in Issue

Abstract:  Closed-system transfer devices enhance the drug handlers’ protection against hazardous drugs exposure by prohibiting the escape of liquid or vapor from the system. PhaSeal (Becton Dickinson), a reference closed-system transfer device, includes a vial protector with an expansion chamber, and an injector with an enclosed needle. VialShield (CareFusion) is another more recent closed-system transfer device including an expansion chamber and a non-return valve, designed to be used in association with Texium (CareFusion), a closed, needlefree male luer with its preassembled syringe. Evaluation of VialShield/Texium was done comparatively to a classic spike device (Spike Swan, Codan) and PhaSeal. Evaluation methods consisted in practical evaluation by pharmacy technicians (evaluation of ease to use by nine operators in practical conditions during a complete week of production), microbiological safety performance (by Media Fill Test), and leakage assessment (fluorescein, titanium tetrachloride smoke, and radioactive tracer). Results showed that 100% of those operators evaluated would be ready to use VialShield/Texium for daily use, whereas only 75% of them would be ready to use PhaSeal. The use of PhaSeal and VialShield/Texium increased the duration of preparations compared to Spike Swan. No microbiological growth was observed with any of the three devices. A leakage of smoke was observed only with Spike Swan. Fluorescein leakage assessment confirmed that PhaSeal is a performing closed system with a dry connection. Spike Swan showed fluorescein leaks. Fluorescein drops were visible on the connection sites of the VialShield/Texium. Nevertheless, no fluorescein was found on compress after connections swapping. Transfer performance, assessed using technetium-99m, was 98.1 ± 1.4%, 97.9 ± 1.1% and 97.0 ± 1.3% and dead volume of the devices, were 1.0 ± 0.8%, 1.7 ± 0.6%, and 3.0 ± 1.1% for Spike Swan, PhaSeal, and VialShield/Texium, respectively. VialShield/Texium appeared as a very interesting device with performances close to PhaSeal (except dry connection), with a higher satisfaction assessment from the operators.

Related Keywords: Philippe Garrigue, PharmD, Marc Montana, PharmD, PhD, Christophe Ventre, Amandine Savry, PharmD, PhD, Laurence Gauthier-Villano, PharmD, Pascale Pisano, PharmD, PhD, Bertrand Pourroy, PharmD, PhD, cytotoxic drug preparations, hazardous drug handling, closed system transfer devices, environmental contamination, PhaSeal, VialShield, Texium, ease of use, microbiological safety performance, media fill test, leakage assessment, transfer performance, pharmacy technician, production workflow


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal) Garrigue Philippe, Montana Marc, Ventre Christophe, Savry Amadine, Gauthier-Villano Laurence, Pisano Pascale, Pourroy Bertrand Mar/Apr 2016 148-154 Buy
Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates) Brandin Thibaut, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice Mar/Apr 2022 150-154 Buy
Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon Jul/Aug 2020 322-326 Buy
Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD Allen Loyd V Jr Nov/Dec 1997 381-385 Buy
Use of a Closed-system Drug Transfer Device (PhaSeal) and Impact on Preparation Time Sanchez-Rubio Ferrandez J, Lozano M C, Iglesias I, Sanchez-Rubio Ferrandez L, Rodriguez Vargas B, Moreno Diaz R Sep/Oct 2012 431-433 Buy
Development and Validation of a Stability-indicating High-performance Liquid Chromatographic Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches Burrows Anna C, Yellepeddi Venkata Kashyap, Snyder Spencer, Wakefield Meagan, Jackson David, Huynh Johnny, Nguyen Khoa, Sayre Casey L Jul/Aug 2019 340-350 Buy
Antineoplastic Drug Contamination on the Outside of Prepared Infusion Bags Breukels Oscar, van der Gronde Toon, Simons-Sanders Kathleen, Crul Mirjam Jul/Aug 2018 345-349 Buy
Microwave Freeze-thaw Technique for Injectable Drugs: A Review Updated from 1980 to 2021 Hecq Jean-Daniel, Soumoy Laura, Closset Mélanie, Colsoul Marie-Lise, Jamart Jacques, Galanti Laurence Nov/Dec 2021 446-462 Buy
Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations Visser J Carolina, ten Seldam Inge E J, van der Linden Isabella J, Hinrichs Wouter L J, Veenendaal Reinier F H, Dijkers Eli C F, Woerdenbag Herman J May/Jun 2018 247-251 Buy
The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013 Lutz Eugene, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc Jan/Feb 2014 6-12 Buy