PDA EU00189 Best Practices for Glass Primary Containers

Mainz, Germany
Ask a Question Exhibitor Standard Contract Clause
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

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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

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.

PDA recommends the reservation at the following hotel

AC Hotel Mainz
Bahnhofplatz 8
55116 Mainz
Germany