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Container Closure Integrity Testing – Basic Course - Fall Edition

Oct 24 - Oct 25, 2019
Gothenburg, Sweden

  • Education
  • Europe

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This 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 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 course, participants gain critical problem solving skillsthrough:

  • 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, 24 October 2019

    Welcome and Introduction
    Learning objectives and benchmarking questionnaire

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

    CCI Assurance throughout Product Lifecycle

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

    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

    CCI Testing Technologies

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

    Coffee Break

    Application Case Studies (Part 1)(continued)

    • 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

  • Friday, 25 October 2019


    Application Case Studies – Cont.

    • Mass Extraction
    • AMI Optical emission spectroscopy for CCI testing

    Hands-on Training

    Coffee Break

    Application Case Studies – Cont.

    • Headspace analysis
    • HVLD

    Hands-on Training – Cont.

    Lunch Break

    Development and Validation of Integrity Test Methods

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

    Approaches to CCI Testing Method Selection

    Method selection considerations

    Introduce Group Exercise:
    Product life cycle testing and method selection

    Coffee Break

    Group Exercise - Breakout

    Group Exercise - Presentations & Discussion

    End of Course


Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Lei Li
Lei Li
Eli Lilly and Company

Additional Information

  • Learning Objectives

    Learning Objectives

    This 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, laserbased 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.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.

    You can book your Hotel Accomodation here!

  • Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.


Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (25%)

* 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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