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2023 PDA_Training-1988x680

PDA EU00135 Best Practices for Glass Primary Containers

Apr 12 - Apr 13, 2023
Mainz, Germany

  • Education
  • Europe
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Program Highlights

This course will include a Site Visit at the SCHOTT facilities on the 12 April 2023!

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.

Overview

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.

Prerequisites

  • Technical aptitude
  • Some familiarity with pharmaceutical fill/finish processes
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Agenda

  • Day 1
  • Day 2

  • Wednesday, 12 April 2023

    9:00
    Welcome and Introduction
    Participants' Expectations

    Manufacture and Characteristics of Glass as Primary Packaging Material

    9:15
    Glass Science

    • Chemical structure
    • Physical properties
    • Different glass types in the pharmaceutical industry
    10:30
    Coffee Break

    11:00
    Glass Making

    • Glass Melting
    • Tubing Production
    • Container conversion
    • Molded containers
    12:00
    Lunch Break

    13:00
    Glass Strength and Fracture Mechanics

    • Trigger for glass breakage
    • Crack formation and propagation
    • Theory of Fractography

    14:30
    Site Visit SCHOTT Tubular Glass Manufacturing

    16:00
    Coffee Break

    Receiving Inspection of Glass Primary Packaging Material

    16:15
    Requirements from Pharmacopoeias (EP, JP, USP) and Incoming Inspection

    • Overview Pharmacopoeia
    • Testing Parameters
    • Testing Methods, Equipment, Tools
    • Defects and PDA Technical Report #43

    17:00
    How to Do in Practice

    • Sampling (AQL)
    • Sample size
    • Testing
    • Documentation
    • Supplier certification & test reduction
    17:30
    End of Training Course Day 1

  • Thursday, 13 April 2023

    9:00
    Recap of Learning Objectives Day 1

    Receiving Inspection of Glass Primary Packaging Material (cont.)

    09:30
    What to Consider, What are the Common Problems, How to Avoid Them

    • Indications for (later) glass breakage | Practical examples
    10:15
    Coffee Break

    10:45
    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

    11:15
    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

    15:30
    Q&A

    16:00
    Summary & End of Training Course

Trainers

Markus Heinz
Markus Heinz
Syntegon
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.
Florian Maurer
Florian Maurer
SCHOTT AG
Bio
Florian Maurer
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
Karl Siemoneit
Sanofi-Aventis
Bio
Karl Siemoneit
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 has held various management positions in technical and quality areas. Karl Siemoneit obtained his degree in Biology from the University of Ulm, Germany.
Folker Steden
Folker Steden
SCHOTT
Bio
Folker Steden
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.

Additional Information

  • Learning Objectives

    Learning Objectives

    • 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
  • Who Should Attend
    • Packaging engineers
    • Quality personnel
    • Filling line technicians
    • Supervisors and engineering support
    • Those responding to failure complaints
    • Root cause investigators

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

IntercityHotel Mainz

Binger Str. 21
Mainz, Germany

  • Accommodations

    Hotel Nearby

    PDA Europe recommends the reservation at the following hotel:

    IntercityHotel Mainz
    Binger Str. 21, 55131 Mainz
    Tel: +49 6131 588510

  • Amenities

How to Get Here

By Air

Nearest Airport: Frankfurt Airport - FRA Airport Phone: +49 0180 6 3724636; Distance: 32,0 km; Estimated cab fare: 45,- EUR (one way)

By Car

IntercityHotel Mainz has its own parking garage with e-charging station; Cost: 2,30 EUR/hour, 19,- EUR/day

Other Options

Mainz main station; Distance: 0,5 km

Directions

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