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Volume 14
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Article

Performance Qualification of Automatic System for Antineoplastic Preparation

by
Giuseppe Tesse
1,
Giuseppe Capasso
1,
Stefano Brattoli
1,
Anna Tolomeo
1,
Vincenzo Dimiccoli
1,
Marco Spartà
2,
Stefano Mazzotta
3,
Giuseppe Altieri
4,
Anna Giannelli
4,
Domenica Ancona
4 and
Letizia Giampietro
5,*
1
Radiopharma Division, ITEL Telecomunicazioni s.r.l., 70037 Ruvo di Puglia, BA, Italy
2
Bioduct s.r.l., 50141 Firenze, FI, Italy
3
Studio Effemme Chimica Applicata s.r.l., 73018 Squinzano, LE, Italy
4
Farmacia Ospedaliera, Ospedale Monsignor Raffaele Dimiccoli, 70051 Barletta, BT, Italy
5
Department of Pharmacy, Università Degli Studi G. d’Annunzio, 66100 Chieti, CH, Italy
*
Author to whom correspondence should be addressed.
Appl. Sci. 2024, 14(1), 106; https://doi.org/10.3390/app14010106
Submission received: 4 October 2023 / Revised: 12 December 2023 / Accepted: 19 December 2023 / Published: 21 December 2023
(This article belongs to the Special Issue Medical Robotics: Advances, Applications, and Challenges)
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Abstract

The preparation of antiblastic and parental drugs should be carried out by ensuring an aseptic condition and minimizing exposure to toxic drugs. The aim of this study is to evaluate the quality and qualification of these features of an automated dispensing system, called PHARMODUCT®, built by Bioduct s.r.l, part of the Dedalus group. Three antiblastic drugs (cyclophosphamide (powder), 5-fluorouracil and paclitaxel) were used and three preparation and dispensing sessions were carried out for each drug, using PHARMODUCT®. Some of the infusion bags, prepared for each type of antiblastic, were sent to an external laboratory to perform the quantitative dosage analysis and compare it with the quantitative concentration, set on the automatic dispensing equipment, which was found to meet the acceptance criteria of 10%. In addition, to assess the safety of the process for operator exposure to toxic drugs, the differential pressure value between the main chamber and the clean room was measured to be ˂0 Pa, with an hourly leakage rate of ˂2.5 × 10−3 h−1. Media fill tests showed no microbiological growth after a 14-day incubation period. The PHARMODUCT® system meets the requirements of safety and repeatability for the dispensation of parenteral antiblastic drugs.
Keywords: antineoplastic drugs; automated compounding; aseptic processing; robotics; dispensing module antineoplastic drugs; automated compounding; aseptic processing; robotics; dispensing module

Share and Cite

MDPI and ACS Style

Tesse, G.; Capasso, G.; Brattoli, S.; Tolomeo, A.; Dimiccoli, V.; Spartà, M.; Mazzotta, S.; Altieri, G.; Giannelli, A.; Ancona, D.; et al. Performance Qualification of Automatic System for Antineoplastic Preparation. Appl. Sci. 2024, 14, 106. https://doi.org/10.3390/app14010106

AMA Style

Tesse G, Capasso G, Brattoli S, Tolomeo A, Dimiccoli V, Spartà M, Mazzotta S, Altieri G, Giannelli A, Ancona D, et al. Performance Qualification of Automatic System for Antineoplastic Preparation. Applied Sciences. 2024; 14(1):106. https://doi.org/10.3390/app14010106

Chicago/Turabian Style

Tesse, Giuseppe, Giuseppe Capasso, Stefano Brattoli, Anna Tolomeo, Vincenzo Dimiccoli, Marco Spartà, Stefano Mazzotta, Giuseppe Altieri, Anna Giannelli, Domenica Ancona, and et al. 2024. "Performance Qualification of Automatic System for Antineoplastic Preparation" Applied Sciences 14, no. 1: 106. https://doi.org/10.3390/app14010106

APA Style

Tesse, G., Capasso, G., Brattoli, S., Tolomeo, A., Dimiccoli, V., Spartà, M., Mazzotta, S., Altieri, G., Giannelli, A., Ancona, D., & Giampietro, L. (2024). Performance Qualification of Automatic System for Antineoplastic Preparation. Applied Sciences, 14(1), 106. https://doi.org/10.3390/app14010106

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