PDA EU00189 Best Practices for Glass Primary Containers
Registration Options
Individual Registration
Group Registration
Program Highlights
This course will include a Site Visit at the SCHOTT facilities on the 11 June 2024!
This 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.
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 parenteral 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
Learning Objectives
Upon completion of this course, attendees will be able to:
- 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
Contact
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Standard Pricing
Standard Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Tuesday, 11 June 2024
8:45
Welcome and Introduction
Participants' Expectations
Manufacture and Characteristics of Glass as Primary Packaging Material
9:00
Glass Science
- Chemical structure
- Physical properties
- Different glass types in the pharmaceutical industry
9:45
Glass Making
- Glass melting
- Tubing production
- Learning from mistakes: Glass defects
10:40
Coffee Break
10:55
Glass Converting Process
- Glass containers for pharmaceutical application
- Container production from glass tubing
- Factors that affect surface chemistry in glass conversion to vials
- Molded container production
- Additional proprieties with internal and/or external treatment/coating
12:20
Lunch Break
13:20
Glass Strength and Fracture Mechanics
- Glass breakage - Fundamentals
- Assessment of flaws
- Fractography - Fundamentals
14:50
Practice and Hands-on Demonstration: Fractography
15:35
Site Visit SCHOTT Tubular Glass Manufacturing
17:05
Coffee Break
Receiving Inspection of Glass Primary Packaging Material
17:20
Requirements from Pharmacopoeias (EP, JP, USP) and Incoming Inspection
- Overview Pharmacopoeia
- Testing Parameters
- Testing Methods, Equipment, Tools
- Defects and PDA Technical Report #43
18:00
End of Training Course Day 1
Day 2
Wednesday, 12 June 2024
8:45
How to Do in Practice
- Sampling (AQL)
- Sample size
- Testing
- Documentation
- Supplier certification & test reduction
Receiving Inspection of Glass Primary Packaging Material (cont.)
09:15
Inspection of Glass: What to Consider, Common Problems
- Practical examples, case study
10:00
Coffee Break
10:30
Coordination Process Packaging Manufacturer and Customer
- Important parameters | Measured variables | Regulating variables | Control loop |Interaction with manufacturer | Effort reduction
Machine Use of Glass Primary Packaging Material
11:00
Machine Runability of Glass Primary Packaging Material
- Roughness of glass primary packaging material | Geometrics, tolerances | Quality of glass | Impact of machine speed
11:45
Lunch Break
12:45
Use of Glass Primary Packaging Material Along the Process Chain Considering different kind of containers, bulk and nested:
- Washing machine | Depyrogenation tunnel | Filling machines | Stoppering | Rod insertion and labelling for syringes | Conveyor belts | Automated inspection | Packaging line
13:30
Case Study: What to Consider, What are Common Problems, How to Avoid Them
- Collision analysis
- Basics of good glass handling
- Technologies to avoid glass to glass contact
14:15
Coffee Break
14:45
Coordination Process Primary Packaging Material and Machine
- Important parameters | Control loop | Synchronization
15:15
Questionnaire
16:00
Final Q & A
16:15
End of Training Course
Featured Trainers
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Markus Heinz
Syntegon
Read Bio
Markus Heinz
Syntegon
Markus Heinz has a bachelor’s degree in industrial and mechanical engineering as
well as a master’s degree in international management. He joined Syntegon Technology GmbH (former Bosch Packaging Technology) in 2008.During his first years, he was a sales manager for handling complex customer projects within the D-A-CH region.
Since 2019, he is the globally responsible product manager for vial liquid and powder applications. His expertise includes process engineering, bulk and ready-to-use handling, filling and closing technologies for liquid and powder medications, aseptic and high-potent Isolator applications as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia.
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Florian Maurer, PhD
SCHOTT AG
Read Bio
Florian Maurer, PhD
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.
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Serena Panighello
Stevanato Group
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Serena Panighello
Stevanato Group
Serena Panighello is a research scientist at EMEA Technology Excellence Center, Stevanato Group. Her role is mainly related to the study of glass corrosion mechanisms and container-drug interaction consultancy. She is involved in the advanced analytical services that TEC Lab offers to the Pharma customers to understand the container’s properties and performances with respect to the customer needs and to mitigate and reduce the risk of interaction of containers with the drugs. She is a member of TC02 and TC12 of ICG (International Commission on Glass). She earned a PhD in Chemical Sciences at Ca' Foscari University of Venice (Italy) within a joint research program with the National Institute of Chemistry, Ljubljana (Slovenia). During the PhD, she was awarded the Paul Award for the best presentation at the New Researchers Forum during the SGT (Society of Glass Technology) annual Conference in Durham (UK). -
Folker Steden, PhD
SCHOTT
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Folker Steden, PhD
SCHOTT
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn, Germany. He completed his PhD doctoral thesis in Inorganic Chemistry at Bonn and New Brunswick, Canada before joining SCHOTT for technical and pharmaceutical tubing applications.
Since 2012, he has been leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and intercultural skills, he is working between customers and local R&D units, focusing on future customer needs.
Folker presents frequently in international conferences on subjects related to special glass for technical and pharmaceutical applications.
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Sonja Wicks
Vetter Pharma
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Sonja Wicks
Vetter Pharma
Sonja started 12 years ago as a team manager at QC incoming goods lab. Here she was able to pursue her quality standards and broad interest in materials and processes but with a special focus, on accompanying the manufacturing processes, tests, and defect patterns of glass packaging materials for 5 years.
For a further 6 years, she also led several teams of experts in the quality control of incoming goods, dealing with regulatory requirements and their systematic implementation, as well as change and method management as part of supplier quality management. Thanks to her broad expertise in these areas, she has now taken over the role of Lead Manager for incoming goods.
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AC Hotel Mainz
Bahnhofplatz 8
55116 Mainz
Germany
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