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2023 PDA_Training-1988x680

PDA EU00107 Container Closure Integrity Testing - Basic Course

Oct 19 - Oct 20, 2023
Gothenburg, Sweden

  • 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.

Overview

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.
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Agenda

  • Day 1
  • Day 2

  • Thursday, 19 October 2023

    9:00
    Welcome and Introduction

    9:15
    Regulatory Requirements:
    CCI Introduction, Regulatory Requirements, and Industry Trends

    10:00
    Introduction

    • Testing requirement definition – risk based approach
    • CCI Profile & Testing strategy development
    • CCI Assurance throughout Product Lifecycle
    10:30
    Coffee Break

    11:00
    CCI Test Methods: Fundamentals

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

    11:30
    Lenox Laser: Laser Drilled Defects

    12:00
    Lunch Break

    13:00
    CCI Test Methods: Overview

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

    13:30
    CCI Testing Technologies

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

    14:30
    Coffee Break

    15:00
    Special Topic: Case Study: Systemic Evaluation of Vial Container Closure System Suitability at Frozen Condition

    15:30
    Application Case Studies (Part 1)

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

    16:10
    Hands-on Training

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

    16:50
    Day 1 Wrap-Up, Q&A

    17:00
    End of Training Course Day 1

  • Friday, 20 October 2023

    8:30
    Welcome

    8:40
    Application Case Studies (Part 2)

    • Vacuum and pressure decay
    • Mass Extraction

    9:20
    Hands-on Training

    • All instrument stations

    10:10
    Coffee Break

    10:40
    Application Case Studies (Part 3)

    • Headspace gas ingress
    • HVLD

    11:20
    Hands-on Training

    • All instrument stations
    12:00
    Lunch Break

    13:00
    Specific Topic - Residual Seal Force: A Powerful Vial Seal Quality Test

    13:30
    Airborne Ultrasound

    14:00
    Approaches to CCI testing method selection

    14:30
    Coffee Break

    15:00
    Development and Validation of Integrity Test Methods

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

    15:40
    Group exercise:
    Product life cycle testing and method selections

    16:10
    Group Exercise - presentations & discussion

    16:30
    End of Training Course

Trainers

Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Bio
Allison L. Dill
Eli Lilly and Company

Allison Dill, Ph.D. is a Principal Research Scientist in Bioproducts Research and Development at Eli Lilly and Company, Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to many regulatory submissions. Her contributions were recognized with an Eli Lilly Top 100 Innovator Award. She has contributed to the corporate CCI strategy as well as the strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection. In her current role, she provides technical leadership enabling the delivery of the bioproducts portfolio within a complex global network with responsibility for the analytical control strategy of both drug substance and drug product across all phases of development.
Coralie A. Richard
Coralie A. Richard
Eli Lilly and Company
Bio
Coralie A. Richard
Eli Lilly and Company

Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, U.S.

A native from France, she came to the U.S. to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards. In her current role she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping and distribution, surface science, and several related DDCS laboratories. Her global team support clinical and commercial development activities across all business units.

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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Travel

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

  • Accommodations

    PDA recommends the reservation at the following hotel

    Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg,
    Sweden

    PDA Europe has reserved a limited number of rooms until the 15th August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here

By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.

By Car

E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.

Other Options

From the main railway station take the number 2 tram (towards Krokslätt) or the 4 (towards Mölndal). From Brunnsparken Square you can also take the number 5 tram (towards Torp). The trams stop at Korsvägen / Svenska Mässan. Tram timetables can be found on the Västtrafik website.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* 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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