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Parenteral Drug Association Connecting People, Science and Regulation ®

Best Practices for Glass Primary Containers

Sep 12 - Sep 13, 2018 |
Sep 13, 2018 |
Intercity Hotel Mainz | Mainz, Germany
  • Education
  • Europe
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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

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


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.

Wednesday, 12 September 2018

Welcome and Introduction Participants' Expectations

Manufacture and Characteristics of Glass as Primary Packaging Material

Glass Science

  • Chemical structure
  • Physical properties
  • Different glass types in the pharmaceutical industry

Coffee Break

Glass Making

  • Glass Melting
  • Tubing Production
  • Container conversion
  • Molded containers

Lunch Break

Glass Strength and Fracture Mechanics

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

Visit SCHOTT Tubular Glass Manufacturing

Coffee Break

Receiving Inspection of Glass Primary Packaging Material

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

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

How to Do in Practice

  • Sampling (AQL)
  • Sample size
  • Testing
  • Documentation
  • Supplier certification & test reduction

End of Day 1

Thursday, 13 September 2018

Recap of Learning Objectives Day 1

Receiving Inspection of Glass Primary Packaging Material (cont.)

What to Consider, What are the Common Problems, How to Avoid Them

  • Indications for (later) glass breakage | Practical examples

Coffee Break

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

Machine Runability of Glass Primary Packaging Material

  • Roughness of glass primary packaging material | Geometrics, tolerances | Quality of glass | Impact of machine speed

Lunch Break

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

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

Coffee Break

Coordination Process Primary Packaging Material and Machine

  • Important parameters | Control loop | Synchronization

Q & A

Summary & End of Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1,495 Euro


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66


Intercity Hotel Mainz
Binger Str. 21
55131 Mainz
Tel: +49 69 66564-460
Hotel Website

Just 450 m away from the main train station is the IntercityHotel Mainz. Explore the old town district on foot, visit the many attractions such as the cathedral and the Gutenberg Museum, or take a stroll along the Rhine promenade!

Despite its proximity to the train station, you can enjoy a peaceful night's sleep in any of our 194 soundproofed rooms and apartments. All rooms feature air conditioning, minibar, safe and a flatscreen TV with Sky Sports and Bundesliga channels! FreeCityTicket granting use of local public transport in Mainz and Wiesbaden at no charge.

PDA Europe has reserved a limited number of rooms until the 13th July 2018.

Room € 179 per night*

*Rates include the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • Taxes and Service will apply

How to Get There

  • Taxi Fees - € 7
  • 5 min. Walk


€ 15 per day


Sponsorship and Exhibit Opportunities are not Available!

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