EUROPE's LARGEST PHARMA CONGRESS WITH COMPREHENSIVE EXHIBITION BRINGS TOGETHER INDUSTRY
The Pharma Congress on Production & Technology will continue to be the meeting point for the industry in 2012. The well-proven concept of previous years has been adopted and advanced for the Congress which will open its doors again on 24 and 25 April in Düsseldorf. The ever-increasing demand for exhibition stands and the continually growing number of participants confirm this successful concept. Using daily tickets, participation is possible on one or both days. Participants can design their individual programme of lectures from all conferences. In the evening and during breaks, participants will have enough time to maintain their networks and make new contacts. Leading suppliers of the pharmaceutical sector will be taking part in the major special exhibition providing information on current technologies and services.
As in 2011, the European Compliance Academy (ECA ) will be conducting several conferences during the 2012 Congress. This time, delegates can choose between the five international conferences
- ECA Conference on Oral Solid Dosage Forms
- ECA Conference on Prefilled Syringes
- ECA Conference on Barrier Systems
- ECA Conference on Current Aseptic Technologies
- ECA Conference on Glass - Glass Breakage - (Micro-) Cracks
with more than 40 speakers, including speakers from Bayer, Boehringer Ingelheim, Cilag, CSL Behring, Roche, Fresenius, Holopack, Lilly, Lonza, Merz, Novartis, Nycomed, Pfizer and Vetter Pharma-Fertigung.
The conference on solid dosage forms will be concentrating on two main topics: increasing efficiency in the manufacture of solid dosage forms and transition to continuous production. This transition is presented by Janssen Pharmaceutica, among others. Janssen Pharmaceutica is a company that has taken this step after conducting thorough analysis.
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The topic of "Glass - Glass breakage - Glass particles and Delamination" and ensuring the integrity of pharmaceutical glass containers for parenterals came under the particular scrutiny of regulatory authorities in 2010/2011. The FDA in particular, was sensitised by several recalls by pharmaceutical companies owing to problems with glass as a packaging material. In the meantime, the FDA has defined its position in detail and formulated clear guidelines for industry at public events and on its homepage. This will have consequences especially for the glass suppliers' quality assurance. The aspect of Quality by Design will be stressed further. Another important point is the treatment of glass containers during the preparation and the filling process. One example represents stress-free transport of glass containers at pharmaceutical companies. The conference on "Glass - Glass breakage - (Micro-) Cracks" will look at the topic from the perspective of the three parties most involved - glass manufacturers, pharmaceutical companies and mechanical engineers.
Glass manufacturers of tubular and moulded glass explain the causes and show new approaches and developments for avoiding and reducing these problems. Several case studies by pharmaceutical companies sensitise for the problems of filling and show practiced approaches to avoiding glass breakages. Mechanical engineers show new developments concerning the stress-free transport of glass containers. But new possibilities for inline-detection of glass breakages will also be presented and the practical suitability thereof evaluated.
The event on "Current Aseptic Technologies" focuses on the presentation of new trends and developments in aseptic production. The central theme of the conference will be to interpret and implement current regulatory requirements such as the revised version of the EU-GMP Guideline's Annex 1 but also new and further developments of existing technologies. A German inspector and two former inspectors of the French regulatory authority will present their point of view on the interpretation of Annex 1 as concerns technological feasibility. Pharmaceutical companies and engineering companies will describe new technological approaches and procedures for aseptic production in several case studies. These approaches and procedures will then be put up for discussion.
Another conference is dedicated to the special technology of prefilled syringes. It can still be observed that prefilled syringes are steadily increasing in importance. The market of prefilled syringes is dominated by syringes delivered by the manufacturers ready for use in tubs.
The conference on "Prefilled Syringes" will pick up on current topics such as the improvement of glass qualities, alternative plastic syringes with their advantages and disadvantages, the decontamination of tubs when infiltrating them in the filling process and the use of prefilled syringes in autoinjectors.
Today, barrier systems are roughly divided into two groups: RABS (Restricted Access Barrier Systems) and isolators. Both systems have points in common, but each also has specific advantages and disadvantages. In terms the operational method, the systems are already approaching one another considerably in some parts. They both separate products and operators by means of a "solid wall". Interventions during production are possible only via gloves. Another crucial difference, including from the inspector's point of view, is that isolators can be operated in clean room classes C or D whereas RABS always needs class B as a background of the aseptic core area in Europe.
In the context of the "Barrier Systems Conference" the advantages and disadvantages of both technologies are dealt with in detail and discussed intensively. New developments at the plant construction firms, case studies taken from pharmaceutical practice and future trends are presented in detail. The focus will be on aseptic barrier systems. But in this context, aspects of the handling of highlypotent active ingredients and drugs will also be addressed.
All further information on the individual conferences, lectures, speakers and exhibitors are available at www.pharma- kongress.com. Only the social event for the evening of 24 April remains a well-kept secret.
Author:
Dr Robert Eicher & Dr Andreas Mangel
CONCEPT HEIDELBERG
