Containment 30 September -1 October 2008 Vienna, Austria Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1490,--) Book this option: ECA Members (EUR 1341,--) Book this option: EU GMP Inspectorates (EUR 745,--) Book this option: APIC Members (does not include ECA Membership) (EUR 1415,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives This event aims at examining the state of the art in the currently widely discussed field of containment. It will deal with the definition of limits, the possibilities offered by measurement technology and verifying safety factors. The use of different devices, equipment as well as practical examples for room concepts are demonstrated through case studies with different pharmaceutical applications in primary, secondary and R&D facilities. Background In the past, safety measures in the handling of active pharmaceutical ingredients (APIs) were often generic. For instance, due to the lack of exposure limits it was impossible to verify the effectiveness of these safety measures quantitatively through measurements. However, in the meantime it has become a standard for pharmaceutical companies to set internal exposure limits for the compounds they handle. So the concept of MAC values defined by authorities has been complemented by the analogous concept of OEL/OEB values specified by pharmaceutical and API manufacturers. Another issue has been raised by EMEA and is still under discussion. Section 3.6 and 5.18 of the GMP Guide provide guidance for the production of high-risk substances. As the wording has left some room for interpretation an update of the guide is under examination. The most important issue is the decision whether or not dedicated facilities will be made mandatory for certain substances. From the industry’s perspective this decision should only be based on a scientific risk analysis. During this conference the following questions represent some of the issues discussed: How are iOEL Limits calculated? How much containment do I need? What should a risk analysis contain? Which impact does containment have on facility design and operation? How are exposition measurements carried out correctly and how should the results be interpreted? What are the different technical solutions? Which kind of zone and layout concepts are reasonable?