Batch control system vaccines: BCSV : A new man machine interface for bioreactors.

The Batch Control System for Vaccines (BCSV), a new Man Machine Interface (MMI) for the control of cultivations in bioreactors, was developed according to SP-88. SP-88 is the ISA standard for Batch Control Systems. Among others, SP-88 supplied the concept of recipes, which organize and specify the monitoring and control requirements for manufacturing. Process optimisation and compliance to GMP rules and regulations were the main objectives for this development.The most important features of the BCSV interface include: - implementation at production, pilot and R & D scale to assure easy transfer of knowledge and experience at the various stage of process development; - independency of underlying hardware to ensure similar "look and feel" for different pieces of equipment; - in-house development and maintenance of recipes to have maximum control over applications; - interactive communication between operator and BCSV during recipe execution. GMP compliance was assured not only by considering governing sets of GMP regulations, but also by taking up the interface in a overall Information & Automation strategy and by setting up a QA strategy for the entire life cycle of the system.

[The frequency of isolating urinary infection germs at a community practice and their sensitivity to various antibiotics]. / Fréquence d'isolement de germes d'infection urinaire en pratique de ville et leur sensibilité aux différents antibiotiques.

Nine hundred and thirty one urine's specimens of patients affected by urinary infection have been studied by pathology practising in different towns in France. The most frequently germs retrieved are: Escherichia coli 76%, Proteus mirabilis 12%, Klebsiella 5%, Staphylococcus epidermidis 2%. Were studied Gram negative rods sensibility to ampicillin (A), cephalosporin 1st generation (C), nalidixic acid (Nal), gentamicin (G), norfloxacin (Norf); Gram positive cocci resistance to oxacillin (Oxa), erythromycin (E), pristinamycin (P), gentamicin (G), norfloxacin (Norf). For E. coli: the resistance was 24% A, 2% C1, 0.1% G, 4% Nal, 0.1% Norf. For Klebsiella: the resistance was respectively 96% A, 12% C1, 10% Nal, 18% G., 4% Norf. For P. mirabilis: 11% A, 3% C1, 0% Nal, 9% G, 0% Norf. E. coli strains cephalo R; Gram negative rods Genta R or quinolone R; staphylocoque oxa R or pristina R have been checked by HIA Begin microbiology laboratory. Discrepancies in results have been analysed. This study enabled the participants to improve their bacteriological technic, antibiogramm's reading, results' interpretation.

Studies in vitro on mouse-egg radiosensitivity from fertilization up to the first cleavage.

Super-ovulated eggs from the Balb/c strain were incubated, at various times after injection of HCG, in Whitten's medium containing tritiated thymidine. They were fixed on the following day at the 2-cell stage and prepared for autoradiography. On the basis of the results, pregnant mice were irradiated with various doses of X-rays at 15 h post HCG (fertilization), 19 h (pronuclear stage before DNA synthesis), 24 h (maximal DNA synthesis) and 27.5 h (DNA synthesis completed). On the day following irradiation, embryos were collected and classified into uncleaved or 2-cell embryos, and development of the 2-cell embryos was followed in culture. Irradiation was most effective when administered at 19 h after injection of HCG. Such a treatment increased the mortality before the first cleavage and, thereafter, from the 8-cell (100 rad) or morula stage (25, 50 rad). Blastocyst hatching and implantation were also impaired. Irradiation at other times was much less harmful for the embryos, which died mainly from the blastocyst stage. Finally, radiosensitivities of the mouse zygote at the various times studied can be estimated as follows: fertilization, + + +; pronuclear stage before DNA synthesis, + + + + +; maximal DNA synthesis, +; DNA synthesis terminated, + +.