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2021 TC-Glass_1988x680

PDA EU00135 Best Practices for Glass Primary Containers

Feb 15 - Feb 16, 2022
Mainz, Germany

  • Education
  • Europe

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Program Highlights

This course will include a Site Visit at the SCHOTT facilities on the 15 February 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.

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

Agenda

  • Day 1
  • Day 2
  • Tuesday, 15 February 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
  • Wednesday, 16 February 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

Trainers

Florian Maurer
Florian Maurer
SCHOTT AG
Karl Siemoneit
Karl Siemoneit
Sanofi-Aventis
Folker Steden
Folker Steden
SCHOTT AG
Klaus Ullherr
Klaus Ullherr
Syntegon Technology (former Bosch Packaging Technology)

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

    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

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TBD Mainz


Mainz, Germany

How to Get Here

By Air

Nearest Airport: Frankfurt Airport - FRA
Airport Phone: +49 0180 6 3724636

By Car

More information coming soon.

Other Options

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Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

All fees given in Euro and excluding VAT










* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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