At the Joint Conference in the last year, total 32 FDA officers and 24 speakers spoke according to common theme “Modernization based on harmonization, implementation and science to achieve future vision” and there were hot discussions at each session. As a course of story, I select presentations related to important matters such as ICH Q Trio, challenges in global market development and drug production and development by scientific business approach, and report the summary.
The efficacy of low-energy, compact electron beam (EB) treatment for the surface sterilization of plastic container was studied. Electron energy of 150 keV, the lowest energy studied in applied research, was used in this experiment. The inactivation of spores of Bacillus pumilus ATCC 27142 was successfully demonstrated. Two microbiological methods, direct counting and fractional outgrowth, were used to measure the electron beam kill effectiveness for doses ranging from 3 kGy to 25 kGy. The resultant log-linear survival curve showed that the D10 value of B. pumilus is 1.4 kGy. This value is in good agreement with other researchers' results using EB and/or gamma irradiation. Extrapolation of the linear regression model from the survival curve also indicated that approximately 9 kGy was sufficient for a 6-log reduction. This was confirmed by the fractional outgrowth testing at the 12 kGy dose. This work demonstrates that low-energy EB is a novel in-line, room temperature method for sterilization of drug containers used in aseptic filling. The process is a viable alternative to the traditional in-house methods that employ ethylene oxide, steam, or hydrogen peroxide, and eliminates the need for chemicals or process water and the costs associated with their disposal. Cost, logistic and process validation issues associated with off-site sterilization methods such as high energy EB or gamma irradiation are also avoided.
The fourth year of revised Pharmaceutical Affairs Law enforcement We appreciate you applicants very much. We have implemented the certification practive over 700 items and more than about 200 cases per year. Certification practice division was limited to an item to become an application of JIST0601-1 at first of a revision to the act, nonetheless, number of cases have been thankfully increased steadily. On the other hand, we had a lot of inquiries about the other items (non-active medical equipment) from many applicants from the beginning and are sorry for the inconvenience, however we measured up to enlarge the sphere of business about the other division in January, 2007 and can involve in all specific controlled medical equipment certification practices. I gather up demands and expectations from Marketing Approval Holders as the applicant to our certification organization which I felt through these certification practices and my idea for the roles that we should carry out as the certification organization and report them.