OYSTAR offers seminar series for “Experts of Solids”
OYSTAR Hüttlin, an internationally leading manufacturer of processing equipment, has begun a series of seminars designed to impart process technology know-how. The series commenced in February with the two-day seminar entitled “Statistical Design Space Development – From DoE To Granules”, and a further five events are to follow.
The equation is a straightforward one: if steps that ensure a process is monitored and controlled precisely are already taken during the product development stage, this not only reduces the number of production errors and rejects but also the costs. In order to solve this equation, however, enterprises in the pharmaceutical industry require a constant: a profound understanding of the process. Only with this knowledge is it possible to assure continuous quality and cost control at all times. In order to make this process technology know-how available, the Pharma Service at OYSTAR Hüttlin is holding a series of seminars in which the latest technologies are presented. The series began on February 17 with the two-day seminar entitled “Statistical Design Space Development – From DoE To Granules”. Twenty attendees – specialists in the development and production of solid dosage forms – acquired theoretical knowledge on Design of Experiment (DoE) and subsequently had the opportunity to put this know-how immediately into practice in OYSTAR Hüttlin’s own laboratory, where the participants themselves performed and analyzed granulation trials.
Quality by Design
The goal of the seminar instructors was to assist the participants in dealing skillfully with the latest methods of Design of Experiment. Pascal Wehrlé, professor at the University of Strasbourg, thus first of all familiarized the participants with the basic concept of “Quality by Design” for quality assurance during the product and process design phase. Prof. Wehrlé then rounded off the subject with a talk on the theory of Design of Experiment. With the help of DoE, the correlation between previously specified influencing factors and target figures is ascertained using as few trials as possible. This allows sufficient knowledge about the process to be obtained. Marcus Knöll, head of Pharma Service at OYSTAR Hüttlin, used FMEA (Failure Mode and Effects Analysis) to provide a detailed overview of the influencing factors in fluid bed granulation: the supply air flow and temperature as well as the spray air must be controlled in order to achieve the desired properties, such as the particle size distribution of the granules.
In preparation for the practical part of the seminar, Erik Johansson, senior application analyst at Umetrics, expounded the subject of “full factorial designs”. Full factorial designs form the basis for DoE by allowing all the interactions between the influencing factors to be identified. Equipped with sufficient theoretical knowledge, the seminar participants then developed their own case studies with the help of the MODDE software and went directly into the laboratory with them for the practical implementation on the fluid bed granulator. Afterwards, the granules made by the participants themselves were analyzed and checked on the basis of DoE.
Sound understanding of the process
Pascal Wehrlé began the second day of the seminar with an introduction to the SPC (Statistical Process Control) methodology for optimized process stability. Means for checking and quantifying the variability were presented using the cause-and-effect diagram according to Ishikawa. Erik Johansson then continued with the subject of “fractional factorial designs”. In contrast to full factorial designs, only certain combinations of factors are gone through here, and this primarily finds its application in screening. Afterwards, Andrea Hartung, a staff member of the Pharma Service at OYSTAR Hüttlin, presented real process data from a granulation of the angiotensin converting enzyme (ACE) inhibitor Enalapril obtained with the help of DoE. The seminar attendees could therefore deepen their understanding of the process by way of a specific example. Finally, the raw data from the previous day’s case study was again checked to see whether a Design Space had been achieved, and the results were then presented and talked over during an open discussion.
Following on from this first seminar, three further events will take place in 2010 to complete the series and will cover the areas of cleaning and validation as well as granulation and coating. Participants attending all four seminars will gain the “Expert of Solids” qualification. It is, however, also possible to attend just individual events only. With two additional seminars on the subjects of scale-up and Process Analytical Technology (PAT), attendees are also able to gain the “Master of Solids” qualification.
More info:
www.oystar.de