Glass vials, ampoules, syringes and cartridges are commonly used in packaging of parenteral pharmaceuticals. Good glass handling practices are essential to assuring glass-based container performance as intended in maintaining the safety and efficacy of the drug product.
The two-day course will offer insights into the science of glass and its inherent properties. It will review container design and dimensioning, cover glass strength and fracture mechanics as well as review the fundamental principles of good glass handling and inspection. The course will follow step-by-step the processes for packaging of parenterals in vials, ampoules, cartridges and syringes. Further insights into glass breakage including an overview of fracture analysis using fractography will be presented.
Who Should Attend
- Packaging engineers
- Quality personnel
- Filling line technicians
- Supervisors and engineering support
- Those responding to failure complaints
- Root cause investigators
- Technical aptitude
- Some familiarity with pharmaceutical fill/finish processes
- Understands the nature of glass
- Knows what glass breakage causes
- Is aware of regulatory requirements and how to perform QC incoming inspection
- Knows how to inspect glass containers for breakage-relevant defects
- Is able to apply the knowledge to avoid glass breakage in the filling line
- Is able to apply a structured way of evaluating in case of glass breakage
- Is able to ‘read’ from the splinters and broken glass
Claudia Heinl, PhD, Product Manager Pharmaceutical Tubing, SCHOTT AG
Claudia Heinl studied Chemistry and Biology for teaching profession before she obtained her PhD in Inorganic/Organometallic Chemistry at the University of Regensburg, Germany. In December 2015, she joined the Scientific Services and Product Management team of SCHOTT AG Tubing being responsible for providing global scientific support. This primarily includes glass trainings for converters and pharmaceutical companies, fault analyses of defect samples as well as advice on specific regulations.
Florian Maurer, PhD, Senior Scientist for Strength, Reliability & Lifetime and Fractography at SCHOTT AG
Florian Maurer earned his doctorate in Materials Science and Engineering in 2007 at Darmstadt University of Technology, Germany. Since then, he has been with SCHOTT with focus on strength, reliability & lifetime and fracture analysis of glass primary packaging containers used in the pharmaceutical industry. Florian and his team provide a powerful toolbox for the identification, characterization and the assessment of flaw-creating mechanisms, which can occur during manufacturing, processing and transportation of glassware.
Karl Siemoneit, PhD, Head Quality Supplier Management, Sanofi-Aventis
Karl Siemoneit is Head of Quality Supplier Management for the Sanofi Insulin manufacturing operations in Frankfurt-Hoechst. This role includes incoming testing and release of primary packaging components such as vials, cartridges and closure components. Karl has over 20 years industrial experience in the IVD / medical device and pharmaceutical industry. He held various management positions in technical and quality areas. Karl Siemoneit obtained his degree in Biology from the University of Ulm, Germany
Klaus Ullherr, Senior Product Manager, Robert Bosch GmbH
Klaus Ullherr has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid. During the first two years, he was responsible for handling complex customer orders. Since 2002, he is product manager for the business fields syringes and filling systems with global product responsibility. His main responsibilities are Market Analysis, Initiating New Product Developments, and Business development. He is an expert for syringe processing. He is member of the “PDA Interest Group Pre-filled Syringes” and works as an expert in the DIN/ISO group for primary packaging. He is a popular speaker at conferences covering trends and solutions for fill/finish equipment especially for pre-filled syringes and single-use-filling-systems.