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Parenteral Drug Association Connecting People, Science and Regulation ®

Best Practices for Glass Primary Containers

Oct 09 - Oct 10, 2019 |
Oct 10, 2019 |
TBD | 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

Wednesday, 09 October 2019

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
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

Thursday, 10 October 2019

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

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

1,595 Euro

Contact

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

More information coming soon.

Sponsorship and Exhibit Opportunities are not Available!

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https://store.pda.org/Meetings/Login.aspx?ID=4594

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