PDA EU00135 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 3 May 2022!

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.

Note   In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

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
  • 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

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
training-europe@pda.org
Registration Customer Care

Standard Registration

Member Price

€1.795

GovernmentMember Only

€1.795

Health AuthorityMember Only

€1.795

Early Career ProfessionalMember Only

€1.795

StudentMember Only

€1.795

AcademicMember Only

€1.795

Non-Member

€1.795

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, 3 May 2022

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 Day 1

Day 2

Wednesday, 4 May 2022

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
Agenda is subject to change.

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TBD Mainz


Mainz, Germany , Germany
How to Get Here
By Air Nearest Airport: Frankfurt Airport - FRA Airport Phone: +49 0180 6 3724636