PDA EU00107 Container Closure Integrity Testing - Basic Course
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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.
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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Member Price
€1.895GovernmentMember Only
€1.895
Health AuthorityMember Only
€1.895
Early Career ProfessionalMember Only
€1.895
StudentMember Only
€1.895
AcademicMember Only
€1.895
Non-Member
€1.895
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, 19 October 2023
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: Case Study: Systemic Evaluation of Vial Container Closure System Suitability at Frozen Condition
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, 20 October 2023
8:30
Welcome
8:40
Special Topic: Single Use Systems
9:10
Application Case Studies (Part 2)
- Vacuum and pressure decay
- Mass Extraction
9:50
Hands-on Training
- All instrument stations
10:30
Coffee Break
11:00
Application Case Studies (Part 3)
- Headspace gas ingress
- HVLD
11:40
Hands-on Training
- All instrument stations
12:00
Lunch Break
13:00
Hands-on Training
13:20
Specific Topic - Residual Seal Force: A Powerful Vial Seal Quality Test
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
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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.
The Swedish Exhibition & Congress Centre - Gothia Towers Hotel
Mässans Gata 24Gothenburg, Sweden , Sweden
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.
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.