Container Closure Integrity Testing – Basic Course - Fall Edition

Gothenburg, Sweden
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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 no longer be provided to participants.

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.

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

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


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, 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

Day 2

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
Agenda is subject to change.

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

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!

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.