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2023 PDA_Training-1988x680

PDA EU00107 Container Closure Integrity Testing - Basic Course

Apr 25 - Apr 26, 2024
Copenhagen, Denmark

  • Education
  • Europe

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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.


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.


  • Day 1
  • Day 2
  • Thursday, 25 April 2024

    Welcome and Introduction

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


    • Testing requirement definition – risk based approach
    • CCI Profile & Testing strategy development
    • CCI Assurance throughout Product Lifecycle

    Coffee Break

    CCI Test Methods: Fundamentals

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

    CCI Test Methods: Overview

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

    Lunch Break

    CCI Testing Technologies

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

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

    Coffee Break

    Application Case Studies (Part 1)

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

    Airborne Ultrasound

    Hands-on Training

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

    Day 1 Wrap-Up, Q&A

    End of Training Course Day 1

  • Friday, 26 April 2024


    Special Topic: Single Use Systems

    Application Case Studies (Part 2)

    • Vacuum and pressure decay
    • Mass Extraction

    Hands-on Training

    • All instrument stations

    Coffee Break

    Application Case Studies (Part 3)

    • Headspace gas ingress
    • HVLD

    Hands-on Training

    • All instrument stations

    Lunch Break

    Hands-on Training

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

    Approaches to CCI testing method selection

    Coffee Break

    Development and Validation of Integrity Test Methods

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

    Group exercise:
    Product life cycle testing and method selections

    Group Exercise - presentations & discussion

    End of Training Course


Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Coralie A. Richard
Coralie A. Richard
Eli Lilly and Company

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend
    • Parenteral drug packaging engineers and formulation scientists
    • Laboratory scientific staff and managers
    • Parenteral manufacturing staff
    • Sterility Quality Assurance
    • Regulatory affair scientists
    • Pharmaceutical packaging component manufacturing staff

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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.

Ellehammersvej 20
Copenhagen, Denmark

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Registration Fees

Regular Price
Registration Type Price
All Participants €2.090

* 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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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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