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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Integrity Testing - Fall Edition

Oct 24 - Oct 25, 2019 |
Oct 25, 2019 |
The Swedish Exhibition & Congress Centre Gothia Towers Hotel | Gothenburg, Sweden
  • Education
  • Europe
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This workshop 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 Workshop 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 Workshop, 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.

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

Learning Objectives

This workshop 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


Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly
Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain distribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

Thursday, 24 October 2019

Welcome and Introduction

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

CCI Assurance throughout Product Lifecycle

  • Testing requirement definition – risk based approach
  • CCI Profile & Testing strategy development

Coffee Break

Introduction to Group Exercise #1:
Product life cycle testing and method selection

CCI Test Methods: Fundamentals and Overview

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

Lunch Break

CCI Test Methods: Fundamentals and Overview(continued)

  • Deterministic vs probabilistic definitions
  • Physicochemical methods vs microbiological methods: differences and correlations
  • Microbial and Dye Ingress Testing Basics
  • Seal Quality Testing
  • Introduction group exercise #2: Method Characteristics

Advanced CCI Testing Technologies

  • Vacuum and pressure decay
  • Mass Extraction
  • Headspace analysis
  • Seal Quality Testing
  • HVLD

Coffee Break

CCI Testing Technologies (continued)

  • Tracer gas (helium leak detection)
  • Seal Integrity method example (residual seal force)

Current Topics: Industry Best-Practices and Novel Technologies

  1. AMI Optical emission spectroscopy for CCI testing
  2. API Container Testing using HeLD; Review Helium leak detection video

Group Exercise #2: Method Characteristics

  • review, discussion

Day 1 Review, Q&A

End of Day 1

Friday, 25 October 2019

Application Case Studies – Section 1

  • Vacuum and pressure decay
  • Mass Extraction

Hands-on Training

Application Case Studies – Section 2

  • Headspace analysis
  • HVLD

Coffee Break

Application Case Studies – Section 3

  • Tracer gas (helium leak detection)
  • SQT (Residual Seal Force)

Instrument Demo and Hands-on Training

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
  • Class discussion - examples

Coffee Break

Group Exercise #1: Method Selection Review, Discussion, Q&A

Class Discussion, Recognition, Certification

End of Workshop

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1595 Euro

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


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

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 an official PDA Europe hotel.

You can book your Hotel Accomodation here!

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66

Register Now