30 September – 1 October 2008, Vienna, Austria
SPEAKERS:
Bruce Davis
Astra Zeneca, UK
Dr Andreas Flückiger
F. Hoffmann-La Roche, Switzerland
Frank Generotzky
Baxter Oncology, Germany
Paul Gurney-Read
Gurney-Read Consulting, UK
Dr Peter Müller
Carbogen Amcis, Switzerland
Ernst Sander
PhC Pharma Consult, Germany
Jolande Schoemaker
Schoemaker Consultancy, The Netherlands
Dr Harald Stahl
GEA Pharma Systems, Germany
Dr Clemens Stief
Pfizer, Germany |
HIGHLIGHTS:
Theory
- Management of Occupational Health Risks
- Determination of the right level of Containment based on toxicological and pharmacological data
- Assessment of the Containment performance
according to SMEPAC
- Risk based approach to Containment using RISK-MAPP
Case Studies:
- Carbogen Amcis: Containment solutionsfor API development & production
- Pfizer: Containment technology for Development of high potent compounds
- Baxter: Containment for Sterile Manufacturing Containment for high active Biologicals
- Pfizer: NEWCON facility of the year - fully
automated oral solid dosage facility |
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?
Target Group
Line managers and technical experts responsible for handling potent drugs and who are in charge of implementing the appropriate practical measures. Further target groups are users of containment systems who wish to update or enhance their know-how as well as engineers and planners who design, install and qualify such facilities.
Moderator
Dr Harald Stahl
Venue
Renaissance Wien Hotel
Linke Wienzeile/Ullmannstr. 71
1150 Wien, Austria
Phone +43 1 89 102
Fax +43 1 89 102 300
Organisation and Contact
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0
Fax +49 (0) 62 21/84 44 34
info@concept-heidelberg.de
www.concept-heidelberg.de
or download theattached pdf file
For questions regarding content:
Dr Robert Eicher (Operations Director) at +49-62 21/84 44 12,
or per e-mail at eicher@concept-heidelberg.de.
For questions regarding reservation, hotel, organisation etc.:
Ms Marion Weidemaier (Organisation Manager) at
+49-62 21/84 44 46, or per e-mail at
weidemaier@concept-heidelberg.de