INFORMATION EXCHANGE: PHARMA CONGRESS PRODUCTION & TECHNOLOGY 2011
After the enormous success of the Pharma Congress 2010 and the great enthusiasm from all sides, the concept will be kept in Düsseldorf/Neuss for 2011. However, the Congress will be expanded further and, with five international and also five national GMP/FDA Conferences, it will offer participants a thematic focus on the key topics of engineering, sterile production, technologies, media and GMP services. In addition, the market leaders will present their new products, technologies and services at the exhibition with over 80 exhibitors this time. This concept proved successful in the past for the Congress participants and also has a significant advantage for the exhibiting companies: they are dealing with a professional audience.
As in the previous year, one day passes for 22 and / or 23 March 2011 will allow Congress participants to put together their own programme from the conferences
- Barrier Systems Conference - RABS
- Barrier Systems Conference - Isolators
- Prefilled Syringes - Current Trends
- Prefilled Syringes - Decontamination Technologies
- Current Aseptic Technologies
on the respective days.
The international events that Concept Heidelberg is organising on behalf of the European Compliance Academy (ECA ) concentrate on the current developments and technologies in sterile manufacturing. The informative "Barrier Systems" and "Prefilled Syringes" topics are seen as stand-alone events.
The GMP requirements for manufacturing sterile pharmaceuticals, particularly if these can be manufactured exclusively aseptically, have increased rapidly in recent years. The trend is increasingly moving towards seeing human beings as the main contamination source in a clean room and separating them from the product. Barrier systems should be seen as state-of-the-art and more and more inspectors and supervisory authorities actually ask for them although the GMP regulations do not definitively require this at present.
Barrier systems are split into two basic groups nowadays: RABS (Restricted access barrier systems) and isolators. Both systems have similarities but also have specific advantages and disadvantages. The two systems are clearly converging nowadays in terms of operational practices and in operating methods. Both separate the product and employee by means of a "solid wall". Any intervention during production is only possible with gloves. The distinct difference, also from the perspective of the inspectors, is that isolators can be operated in a C or D class clean room environment, whereas in Europe, RABS always require class B as background to the aseptic critical area.
Recommendation
1/2 October 2024
Cross Contamination Control - Live Online Training
Within the framework of the Barrier Systems Conference, day 1 will be specifically devoted to RABS. There are still very limited regulations for RABS in comparison to isolators. The range of variation in the systems and their operating methods is also significantly more thorough than with isolators. A basic division can be made between open and closed RABS as well as between active and passive RABS. The event will also look at the advantages and disadvantages of the systems and will discuss the operational fields of application with current case studies as well as the aspects of upgrading existing manufacturing lines in a traditional clean room.
Day 2 will cover isolators. The guidelines on isolators in the pharmaceutical regulations, e.g. the FDA Aseptic Guide, are described clearly in contrast to RABS. The requirements particularly focus on the validation of the decontamination and the operating method according to GMP guidelines. The event will suitably focus on these points. Several case studies will look at aspects of qualification / validation and of routine operations from both the operator and the supplier's perspective. With this information, participants will be able to visualise the intended use of the respective system and decide, in practice, if any questions remain unanswered.
A further trend has been observed in recent years. Prefilled syringes are becoming increasingly important as a system for pharmaceutical applications. In terms of prefilled syringes, it has already been observed that ready-touse syringes, supplied by the syringe manufacturers in tubs, are becoming more important.
The "Prefilled Syringes" Conference will specifically cover two topics. Day 1 will cover the current developments in terms of prefilled syringes from the point of view of the syringe suppliers, system manufacturers and operators, but will also answer any outstanding questions on the processing of prefilled syringes. The focus areas here will be the topics of siliconisation at the glass manufacturer's, pharmaceutical operations, problems and solutions with the operational processing of prefilled syringes and the topic of safety devices. These topics will be presented extensively in case studies of pharmaceutical operations from the different points of view of operators and suppliers.
Day 2 will be devoted to a fairly topical question: how can I avoid a residual risk of microbiological contamination when introducing the closed tubs into the filling process? Tubs are packed with prefilled syringe barrels at the supplier and sterilised in different ways. However, there is a certain risk of microbiological contamination to the outside of the tubs resulting from the transportation to the customer, which could be transferred into the filling process when the tubs are introduced and opened. One solution currently being used is an e-beam tunnel for decontaminating the outside of the tubs, but other alternative processes are also available or are being currently developed. The conference will look at the individual processes and will thoroughly consider the advantages and disadvantages. Experiential reports and case studies from operating these systems will make it easier for you to evaluate them.
Since the revision of Annex 1 of the EU GMP Guide, the topic of capping is still being discussed extensively. The guidelines have been kept very general in parts and are still not 100% clear according to the interpretation of the inspectors within the framework of the PI 0032-2 PIC/s document, "GMP ANNEX 1 REVISION 2008, INTERPRETAT ION OF MOST IMPORTA NT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS." To this end, CONCEPT HEIDELBERG / ECA has commenced a survey within the industry in order to evaluate the current practices within the pharmaceutical industry. The results of this survey will be evaluated from the point of view of an inspector and an industry representative and practice-oriented implementation options will be highlighted by both points of view. In addition to the discussion on the demands for capping, there will also be focus on the current developments in aseptic manufacturing. New developments and trends in the areas of single-use disposables, closed vial technology and lyophilisation will also be presented. Closed vial technology, classed in the "Advanced Aseptic Technologies" group by the FDA with optimum security against contamination, has taken its first steps into the pharmaceutical industry. In addition to the filling of solutions, the option of using this technology in lyophilisation is being further developed as another possible area of application.
Recommendation
Thursday, 24 October 2024 9 .00 - 17.15 h
Container-/Closure-Integrity Testing - Live Online Training
What else is planned in addition to the specialist topics at the conferences? Needless to say, the traditional social event with all participants and speakers. The evening of 22 March will be the next gathering of the industry in pleasant surroundings and with a good atmosphere, music and discussions.
Author:
Dr Andreas Mangel
CONCEPT HEIDELBERG
