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PDA EU00107 Container Closure Integrity Testing - Basic Course

May 31 - Jun 01, 2022
Basel, Switzerland

  • Education
  • Europe

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Program Highlights

Presentation of 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
  • Tuesday, 31 May 2022

    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)

    Methodologies for Sizing CCI Defects Using Gas Flow Dynamics

    Lunch Break

    CCI Test Methods: Overview

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

    Advanced CCI Testing Technologies

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

    Coffee Break

    Special Topic: Preventative Studies Critical Dimensions and Capping

    Application Case Studies (Part 1)

    • Tracer gas (Helium leak detection)
    • Vacuum and pressure decay

    Hands-on Training

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

    Day 1 Review, Q&A

    End of Day 1

  • Wednesday, 01 June 2022


    Application Case Studies (Part 2)

    • AMI Optical emission spectroscopy for CCI testing
    • Mass Extraction

    Hands-on Training

    • All instrument stations

    Coffee Break

    Application Case Studies (Part 3)

    • Headspace analysis
    • HVLD

    Hands-on Training

    • All instrument stations

    Lunch Break

    Approaches to CCI Testing Method Selection

    Method Selection Case Studies

    Development and Validation of Integrity Test Methods

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

    Introduce group exercise:
    Product life cycle testing and method selections

    Coffee Break

    Group Exercise - Breakout

    Group Exercise - Presentations & Discussion

    End of 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.

Congress Center Basel

Messeplatz 21
Basel, Switzerland

Congress Center Basel
  • Accommodations

    Training Location

    Congress Center Basel
    Messepl. 21
    4058 Basel, Switzerland

    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels.
    The general terms of business are valid at the event hotels.

    Pullman Basel Europe
    Clarastrasse 43
    4058 Basel
    Tel: +41616908080

    The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card. 

    Hyperion Hotel Basel
    Messeplatz 12
    4058 Basel
    Tel: +41 61 5604000

    The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centres are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

    It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

  • Amenities

How to Get Here

By Air

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the venue. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the venue.

By Car

The exhibition and congress site has its own direct link to the A2 motorway. The “Messe” exit will take you straight to the Messe Basel car park with its 1,200 parking spaces.

Other Options

From the SBB/SNCF railway station, it’s a ten-minute journey on the No. 1 or 2 Tram to the “Messeplatz/Exhibition Square” stop where Messe Basel and the Congress Center are located. From Badischer Bahnhof railway station, “Messeplatz/Exhibition Square” is the second stop on the No. 2 or 6 tram.


Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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