One of the main challenges in the pharmaceutical industry is selecting the most appropriate primary container system options covering a wide range from traditional glass containers to modern polymer container closure systems. Market segment range from generics to biotech, dosage forms from oral liquids to parenterals. This 2-day training course enables participants to evaluate different packaging systems for liquids and semi-liquids based on formulation properties, market requirements and end-user acceptability. The course is focused on polymer packaging materials and will provide an extensive overview about materials and systems, advantages and limitations. A brief comparison of polymer materials with glass is included in the course, as well as a detailed introduction to blow-fill-seal-technology including container closure integrity testing. Also, the different manufacturing and processes related to the implementation of polymer packaging materials will be discussed. Last but not least, most recent requirements, future trends and innovations in polymer pharmaceutical packaging will be outlined. The course combines classroom lectures with interactive exercises and discussions with experts in this field. The course will be completed with a site visit at a pharma facility, offering a special insight into aseptic blow-fill-seal processing.
Who Should Attend
This course is designed for those involved in
pharmaceutical development and manufacturing of drug
products with responsibilities for selection of container
- CMC experts
- Packaging development and engineering
- Formulation scientists
- Professionals in manufacturing and engineering
Pre-requisite to attend the course is an understanding
of pharmaceutical development including basic primary
packaging aspects. Specific knowledge and expertise in polymers is not required.
Upon completion of this course attendees will be able to
- Develop target profiles for primary pharmaceutical packaging
systems for liquids
- Understand modern pharmaceutical packaging technologies,
materials, applications and requirements
- Compare different primary container systems with their
advantages and limitations
- Understand the specifics of polymer materials used for
- Evaluate the characteristics of manufacturing technologies
for polymer packaging including blow-fill-seal technology
- Select packaging systems based on the evaluation of market
requirements and drug product properties
Jörg Zürcher, Senior Scientist, Bayer
Jörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.
Michael W. Spallek, Director Research & Development, rommelag engineering
Michael Spallek has over 25 years of professional experience that covers pharmaceutical packaging of different dosage forms from oral solids to parenterals and inhalable drug products including medical devices. Michael started his professional career at University of Karlsruhe receiving his PhD. in physical chemistry. He gained experience in medical grade materials from borosilicate glasses to high performance plastics in his role as director of the Pharma Competence Center of Schott AG. Previously he was responsible for global packaging development and Device development at Boehringer Ingelheim Pharma. Currently he is director of the R & D at rommelag, Germany Michael has published over 20 papers and holds several international patents in areas relating to coatings, devices and pharmaceutical packaging.
Bernd Zeiss, Head of Global Technical Support Medical Systems, Gerresheimer
Bernd Zeiss is biologist by education and graduated from the University of Göttingen, Germany. After several years working as a biostatistician, in lab automation and in pharma sales, he today is a member of the Gerresheimer business development team. He works in the Gerresheimer Centre of Excellence for pre-fillable syringes as Head of Technical Support Medical Systems. His main areas of work are technical customer support with regard to syringe systems as well as investigating possible interactions between syringe components and drug substance. He also evaluates innovations like COP syringes in comparison to glass and carries out inhouse functionality studies with prefilled syringes.