Round table: Aseptic preparations [Dose-banding-Automation/Robotic-Facilities - in-process and post-process controls]

6 October 2017

Coordinator : Pr S. Crauste-Manciet2
Expert Panel : Dr F. Puisset1, Dr L. Escalup3, Dr M-L. Brandely4, Pr F. Sadeghipour5, Pr F. Lagarce6, Dr F. Benizri7
1 IUCT Oncopole, Toulouse, France
2 University Hospital Bordeaux, France
3 Curie Institute, Paris, France
4 Paris-Centre Hospital Group (GH), Hôtel Dieu, France
5 University Hospital Lausanne, Switzerland
6 University Hospital Angers, France
7 Paoli-Calmettes Institute, Marseille, France

Objective of the round-table is to discuss with a panel of experts on the last 20 years major evolutions for the preparation of injectable drugs in hospital pharmacies.

The panel of experts will discuss new concepts and technologies introduced in the last 20 years to improve quality and productivity. The increasing needs of injectable preparations, i.e. anticancer drugs, pushed hospital pharmacists to develop smart solutions i.e dose-banding and standard dose concepts, and in collaboration with industry contributed to the development of technologies i.e. containments devices and facilities, automates and robots for preparations and quality control.

The most significant concept introduced in routine production of anticancer drugs is the “dose-banding” strategy designed by G.J Sewell in the UK at the end of the 90’s and presented for the first time at GERPAC in 2006. One can say, it was the starting point for implementation in other European countries. Panel of experts will discuss the main benefits and limits of implementation through pharmacokinetics and technical evaluations.

GERPAC 2006 was also the starting year to present the first commercialized robots specially developed for preparations of injectable drugs in hospital pharmacies. In 2017, it is still a challenge to implement robots in hospital pharmacies because of operators’ mistrust and over-expectations on productivity. Benefits and limits will be discussed during the round-table and balanced with other technical solutions available on the market.

Isolators for aseptic preparation of cytotoxics in hospital pharmacies designed by Bernard Saint Martin in the 90’s was the genesis of the creation of GERPAC. Main evolution of the isolator technology and other containment devices i.e. BSC’s, RABS will be discussed by the panel of expert.

The high load production pressure highlighted the needs for improving the quality control methods firstly limited to double human visual checking. At the end of the 2000’s smart solutions were presented at GERPAC both for “in process” control (video-recording, gravimetric methods) or final analytical analysis of the end-product by dedicated spectrometer (UV-IR, UV-Raman) automates. The expert panel will discuss main benefits and drawbacks of novel methods and strategy for routine quality control.

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