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Parenteral Drug Association Connecting People, Science and Regulation ®

Best Practices for Glass Primary Containers

Oct 18 - Oct 19, 2017 |
Oct 19, 2017 |
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

Prerequisites

  • 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

Instructors

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.

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, 18 October 2017

Training Location:
SCHOTT AG Hattenbergstrasse 10 55122 Mainz | Germany

Competion Clause
We ask you for your understanding that participants of competing companies cannot take part in the site visit on 18 October 2017.

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

  • Melting
  • Molded containers
  • Tube drawing and container conversion
12:15
Lunch Break

13:15
Preparation for Site Visit

13:30
Visit SCHOTT Tubular Glass Manufacturing

14:15
Glass Strength and Fracture Mechanics

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

15:15
Q & A

15:30
Coffee Break

Receiving Inspection of Glass Primary Packaging Material

16:00
Requirements from Pharmacopoeias (EP, JP, USP) and Incoming Inspection

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

16:45
How to Do in Practice

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

17:30
End of Day 1

Thursday, 19 October 2017

Training Location:
InterCityHotel Mainz Binger Strasse 21 55131 Mainz | Germany

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 loopInteraction 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

4 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

All fees given in Euro and excluding VAT (7%)

Contact

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

Schott Exterior

Venue Day 1

SCHOTT AG
Hattenbergstraße 10
55122 Mainz
Germany


Venue Day 2

Exterior

Intercity Hotel Mainz
Binger Str. 21
55131 Mainz
Germany
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 25thAugust 2017

Book your room for the PDA Group Rate by phone.
Room € 135 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

Parking

€ 15 per day

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

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https://www.pda.org/docs/default-source/website-document-library/eu-education/2017/10_glass-handling-best-practices-for-glass-primary-containers/registration-form.pdf

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