Conferences of the 22nd Congress of Biarritz

In spite of a morning schedule, the auditorium of the Bellevue Space shows a rate of record filling of thoughtful participants at a congress.

After a short introduction, Gérard Ecotière, President of A3P, hands over to the Dr. James E. Akers, current Chairman, USP Microbiology and Sterility Assurance, for the first part of the conference, about the future of the Current revision of USP Chapter and the microbiological control and monitoring of aseptic processing environments. James Akers explains the revision of the point USP < 1116 > carrying on the microbiological classification of the clean rooms, in particular, he insists on the fact that control measures (limits of detection of meters CFU) are incapable to prove scientifically " the insurance of infertility " of a plant. Because, of a zero CFU does not mean the absence of contagion, but because, this one is situated below the threshold of current detection. The fact is that most of the laboratories work in clean rooms, in which the sterile products are manipulated in a aseptic way, and not in equipped sterile environments, which do not exist.

In the second part of the morning, Fabrice Bertolini, adviser in hazardous waste, speaking for SITA France, returns on their identification and the bonds of the sender and the producer. He reminds some points of the decree of April 18th, 2002, codified in the Art. R541-7 to R541-11 of the Code of the Environment: " the obligation to insure the elimination of the waste in statutory conditions and allowing to prevent harmful effects of it on the health of people and the environment falls to the producer of waste " (Book V - Titre IV, law of 1975).

Then, by means of clear slides, he indicates elements indispensable to make appear in the compulsory statutory documents: during the orders or during the establishment of the C.A.P, at the level of the labeling of packaging and at the level of the documents of traceability and transport (B.S.D). On this matter, he adds that it is necessary to make sure that hazardous materials are classified and authorized in the transport according to the A.D.R (and in the code UNO). Mixtures or chemically unstable materials are forbidden in particular the transport. Attention, there is no direct link between the code C.E.D and the code UNO.

In last part, Dominique David, expert to the company Assystem, focuses his presentation on the transport of the sensitive pharmaceutical products through three main chapters: the activity of storage and transport in the life cycle of the medicine, the statutory context of the transport of pharmaceutical products and the methodology of qualification and validation of the transport.

In introduction, the speaker defines the notion of sensitive pharmaceutical product and stream of transport, by insisting on the necessity of audits in all the stages of the progress, in particular the intermediate storages. Before his conclusion, he will indicate the added value of Assystem within the framework of the control of the processes of storage and transport. After a series of numerous questions, the participants meet themselves around a coffee on the booths through the exhibition, before taking back the second part of the morning with Jeannette Ewen: towards production intelligence.

For more details consult the presentations of the 22nd Congress.