PDA EU00107 Container Closure Integrity Testing - Basic Course

Gothenburg, Sweden
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Program Highlights

Presentation on Technology, Instruments Demo, and Hands-on Training kindly supported by several suppliers of Container Closure Integrity testing systems and services.

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 be no longer provided to participants.

This training course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The training course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this training course, participants gain critical problem solving skills through:

  • interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
  • hands-on testing training on the newest innovations and state-of-the-art instruments
  • real-world case studies.

This training course utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

  • Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
  • Defining CCI requirements for various container and drug product types using a risk-based approach.
  • Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, mass extraction leak test.
  • Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
  • Defining CCI testing method development and validation approach and best practices.
  • Avoiding common issues and pitfalls in CCI testing applications
Event Location
The Swedish Exhibition & Congress Centre - Gothia Towers Hotel
Mässans Gata 24, Gothenburg, Sweden Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
[email protected]
Registration Customer Care

Standard Pricing

Standard Member Price

€1.895

GovernmentMember Only

€1.895

Health AuthorityMember Only

€1.895

Early Career ProfessionalMember Only

€1.895

StudentMember Only

€1.895

AcademicMember Only

€1.895

Non-Member

€1.895

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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

Thursday, 19 October 2023

9:00
Welcome and Introduction

9:15
Regulatory Requirements:
CCI Introduction, Regulatory Requirements, and Industry Trends

09:45
Introduction

  • Testing requirement definition – risk based approach
  • CCI Profile & Testing strategy development
  • CCI Assurance throughout Product Lifecycle
10:30
Coffee Break

11:00
CCI Test Methods: Fundamentals

  • CCI defects and commonly used positive controls
  • Evolution of CCI testing technology: liquid flow, gas flow, electron flow (electric current)

11:30
CCI Test Methods: Overview

  • Deterministic vs probabilistic definitions
  • Physicochemical methods vs microbiological methods: differences and correlations
  • Microbial and Dye Ingress Testing Basics
12:00
Lunch Break

13:00
CCI Testing Technologies

  • Vacuum and pressure decay
  • Mass Extraction
  • Headspace gas ingress
  • HVLD
  • Tracer gas (helium leak detection)

14:00
Special Topic: Case Study: Systemic Evaluation of Vial Container Closure System Suitability at Frozen Condition

14:30
Coffee Break

15:00
Application Case Studies (Part 1)

  • Tracer gas (Helium leak detection)
  • AMI Optical emission spectroscopy for CCI testing

15:40
Airborne Ultrasound

16:10
Hands-on Training

  • All instrument stations
    • HVLD station
    • Vacuum decay
    • Headspace
    • Helium leak detection
    • Mass extraction
    • AMI Optical Emission Spectroscopy

16:50
Day 1 Wrap-Up, Q&A

17:00
End of Training Course Day 1

Day 2

Friday, 20 October 2023

8:30
Welcome

8:40
Special Topic: Single Use Systems

9:10
Application Case Studies (Part 2)

  • Vacuum and pressure decay
  • Mass Extraction

9:50
Hands-on Training

  • All instrument stations

10:30
Coffee Break

11:00
Application Case Studies (Part 3)

  • Headspace gas ingress
  • HVLD

11:40
Hands-on Training

  • All instrument stations
12:00
Lunch Break

13:00
Hands-on Training

13:20
Specific Topic - Residual Seal Force: A Powerful Vial Seal Quality Test

14:00
Approaches to CCI testing method selection

14:30
Coffee Break

15:00
Development and Validation of Integrity Test Methods

  • Method development best practices
  • Method validation strategy
  • Pitfalls and solutions

15:40
Group exercise:
Product life cycle testing and method selections

16:10
Group Exercise - presentations & discussion

16:30
End of Training Course

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.

The Swedish Exhibition & Congress Centre - Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden , Sweden

PDA recommends the reservation at the following hotel

Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until the 15th August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.


Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here
By Air Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.
By Car E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.