PDA EU00107 Container Closure Integrity Testing - Basic Course
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Individual Registration
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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.
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.
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 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
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Standard Pricing
Standard Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
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, 25 April 2024
9:00
Welcome and Introduction
9:15
Regulatory Requirements:
CCI Introduction, Regulatory Requirements, and Industry Trends
09:45
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
CCI Test Methods: Overview
- Deterministic vs probabilistic definitions
- Physicochemical methods vs microbiological methods: differences and correlations
- Microbial and Dye Ingress Testing Basics
12:00
Lunch Break
13:00
CCI Testing Technologies
- Vacuum and pressure decay
- Mass Extraction
- Headspace gas ingress
- HVLD
- Tracer gas (helium leak detection)
14:00
Special Topic: API Container Testing using Helium leak detection
14:30
Coffee Break
15:00
Application Case Studies (Part 1)
- Tracer gas (Helium leak detection)
- AMI Optical emission spectroscopy for CCI testing
15:40
Airborne Ultrasound
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
Day 2
Friday, 26 April 2024
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
Special Topic - Residual Seal Force: A Powerful Vial Quality Test
13:30
Special Topic: Case Study: Systemic Evaluation of Vial Container Closure System Suitability at Frozen Condition
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
Featured Trainers
-
Allison L. Dill, PhD
Eli Lilly and Company
Read Bio
Allison L. Dill, PhD
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, PhD
Eli Lilly and Company
Read Bio
Coralie A. Richard, PhD
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.
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Request InformationPLEASE 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.
Clarion Hotel Copenhagen Airport
Ellehammersvej 20Copenhagen, Denmark , Denmark
PDA Europe recommends two hotels where you can reserve bedrooms at a reduced rate for that event.
To secure your room, please use the following booking code “PDA Europe”.
Clarion Hotel Copenhagen Airport
Ellehammersvej 20
2770 Kastrup , Denmark
Metro
Take line M2 from central Copenhagen to Copenhagen Airport (approx. 10-15 mins). Then walk through the passageway straight into the hotel lobby.
From the airport
Walk through the passageway from Terminal 3 and straight into the hotel lobby (approx. 2 mins).
Comfort Hotel Copenhagen Airport - The Hangar
Ellehammersvej 18
2770 Kastrup , Denmark
Metro
Take line M2 from central Copenhagen to Copenhagen Airport.
From the airport
The hotel is just a 5-minute walk from Terminal 3.